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Compliance Specialist
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Compliance Specialist
Volunteers of America Chesapeake and Carolina's (V, Baltimore
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Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities and activities may change at any time with or without notice.  EFFECT ON END RESULTS:  To maintain an internal auditing system.  To complete ongoing assessments of the program and services provided to the residents.  To maintain documentation for compliance reviews.  To maintain compliance audit of the agency policies and procedures, including operational procedures.  To assist in maintaining compliance with contractors and regulatory requirements.  To maintain a training curriculum for new and current staff.  To facilitate staff development trainings for all new and current staff.  PHYSICAL REQUIREMENTS:  The physical requirements described below are representative of those that must be met by an employee to successfully perform the essential duties of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential duties.  The ability to safely operate a motor vehicle to transport oneself, consumers, and program supplies as necessary.  The physical ability to travel to assigned locations, stand, stoop, bend, reach, pull, push, lift, grasp, climb, talk, see, hear and perform basic and light home maintenance activities, and operate office equipment.  Move and lift light objects up to 30 pounds such as mail, supplies, files, and equipment. Operating office equipment requiring continuous or repetitive hand/arm movements.  The ability to remain in a sitting position for extended periods of time.  OTHER DUTIES:  Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities and activities may change at any time with or without notice.  REQUIREMENTS Bachelors Degree in a field of organizational administration, public administration, criminal justice, or management. Bachelors Degree in human services with at least two years of human services and/or corrections experience is acceptable. Reasonable combination of the following skills and abilities: organizational, time management, detail oriented, system development, written and verbal communication, interpret compliance requirements and public relations. The ability to multitask and function within a non-traditional work environment. The ability to be a self-started and work independently with limited supervision at times. Experience with Microsoft Word, Excel, Power-point, Outlook Email, and other systems i.e. electronic time punches, electronic medical records etc. Bilingual in any language a plus. EEO/AA
Compliance Specialist / Sr. Compliance Specialist - Newark, DE - Global Operations
AstraZeneca, Newark
At AstraZeneca we turn ideas into life changing medicines. Working here means being entrepreneurial, thinking big and working together to make the impossible a reality. We're focused on the potential of science to address the unmet needs of patients around the world. We commit to those areas where we think we can really change the course of medicine and bring big new ideas to life. As a Compliance Specialist in Newark,DE, Shift: Days: Monday to Friday schedule (4 days a week, 9 hours a day) Hours: 1st ShiftAt AstraZeneca, we work together across global boundaries to make an impact and find answers to challenges. We do this with the utmost integrity even in the most difficult situations because we are committed to doing the right thing. We continuously forge partnerships that help pursue world-class medicines in new ways, combining our people's exceptional skills with those of people from all over the globe.In Operations, we have a big ambition - to deliver more medicines to patients, quicker and more affordable. Backed by investment, leadership, and a clear plan to get there, we bring personal dedication and out-of-the-box thinking.The AstraZeneca Newark Supply Site in Newark, DE, was established in 1971 and currently employs approximately 260 people. Over the course of these years, Newark has undergone many product portfolio changes since it first began as Stuart Pharmaceuticals through today as the designated AZ North America Packaging Center of Excellence and a Flexible Formulation site for global supply of sophisticated products. The site provides a collaborative environment where everyone feels comfortable and able to be themselves is at the core of AstraZeneca's priorities. It's important to us that you bring your full self to work every day. To help maintain your best self, here's a sneak peek into some of the things this site provides for you: on-site fitness center access, lunch & learns, sustainable office working environment, team, site and family activities, life-long learning, diversity & inclusion, tuition reimbursement, and dining center.The core responsibilities of the role are as follows:Manage all Compliance programs and lead/execute required Compliance activities to ensure the site meets current GMP requirements of all local/global regulations and internal AZ Quality and Compliance policies. Provide oversight/process ownership for core Quality Systems including but not limited to; Complaints, Quality Events / Deviations, CAPA, Change Control, Product Reviews, Supplier Quality, Internal Audit Program, and other Quality Systems as needed to support the site.Drive continuous improvements efforts through monitoring/evaluation of site systems & processes against current Compliance requirements and influencing key stakeholders on recommended Compliance improvements. Host/lead/manage inspections of site by External Customers, internal assessors, and Regulatory authorities.Global Operations is fundamental to our purpose of delivering life-changing medicines to patients, touching every aspect of our business and providing a platform for everything that we do. We harness the specialist talents of 13,000 people around the world - 20% of our global workforce. With 30 production facilities in 18 countries we're focused on supplying our medicines with care, quality and efficiency, reducing the time from lab to patient. Keen to bridge the gap between science and patients? Turn research into reality? And forge a global career that's full of possibilities, as part of a world-class team? Come and thrive in our vibrant, energizing, connected and supportive culture and make a real difference to patients.Qualifications:Education:Bachelors degree in a Science / technical field such as Pharmacy, Biology, Chemistry or EngineeringRequired:Minimum of five years experience in the pharmaceutical industry and/or FDA experience and minimum 3 years in Quality Assurance/Compliance. Strong knowledge of global regulatory and cGMP requirements, industry best-practicesStrong familiarity with production operations.Strong leadership, project management, and technical writing.Desired:Minimum of seven (7) years in QA/Regulatory Compliance in the pharmaceutical industry.Prior experience leading/managing regulatory inspections.Experience managing Quality SystemsASQ certifications (e.g. CQA, CQE, CQM).Active member of pharmaceutical trade associations such as ISPE, PDA, etc.AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorization and employment eligibility verification requirements.
Compliance Specialist
Eurofins, Rensselaer
Company DescriptionThe work we do at Eurofins matters, and so do our employees. At Eurofins, we put a focus on your professional growth. We provide our employees the ability to break into the biopharmaceutical industry and grow from the bottom up. We have the supportive teams and tools available to invest in you while also affording you work-life balance and a competitive benefits package.Eurofins Scientific is an international life sciences company, providing a unique range of analytical testing services to clients across multiple industries, to make life and our environment safer, healthier and more sustainable. From the food you eat, to the water you drink, to the medicines you rely on, Eurofins works with the biggest companies in the world to ensure the products they supply are safe, their ingredients are authentic and labelling is accurate. Eurofins believes it is a global leader in food, environmental, pharmaceutical and cosmetics products testing and in agroscience CRO services. It is also one of the global independent market leaders in certain testing and laboratory services for genomics, discovery pharmacology, forensics, CDMO, advanced material sciences and in the support of clinical studies.If you're looking for a rewarding career, a place to call home, apply with us today!Job DescriptionDevelop a comprehensive set of quality metrics aligned with organizational goals and industry standards. This involves collaborating with stakeholders to identify key performance indications (KPIs) and defining measurable objectives.Collaborating with cross functional client Quality and other PSS site team.Collecting data from various process areas, defect reports and performance metrics. Analyze the data to identify trends, patterns, and areas of improvement.Generate regular investigation, training reports to provide visibility into quality performance. Manage quality improvement activities, meetings and other activities supporting the work of the departments.Presenting and Communicate quality related metrics, trends, and insights to stakeholders at various level of the organization. Present findings in meetings, reviews, and reports to facilitate informed decision making.Evaluate and managing resources and task- understanding department needs to evaluate resources needed by implementing the Capacity model system and cross-functional training.Work in a GMP-regulated environment to provide and assist in the implementation of quality-related activities.Assist with other aspects of quality improvement including administrative and operational support as needed.Drive continuous improvement efforts through monitoring/evaluation of site systems & processes aligned with GMP and FDA requirements. To ensure adherence with quality standards and best practices.Evaluate the thoroughness and effectiveness of the training program. Foster a culture of quality awareness and continues improvement throughout the organization.Provide oversight of systems to ensure compliance with internal policies, procedures, and guidelines.QA Essential Duties and Responsibilities:Applies GMP/GLP in all areas of responsibility, as appropriateDemonstrates and promotes the company's visionRegular attendance and punctualityEnsure that the quality policy program is understood, implemented, and maintained at all levels of the organization; identify, prevent, or correct any departures from the quality systemCoordinate workflow and perform daily monitoring to meet TATPerform and/or assign other duties as requested to ensure the smooth operations of departmentQualificationsEducation Requirements:Bachelor's degree in a Science / technical field such as Pharmacy, Biology, Chemistry or EngineeringBasic Minimum Requirements:1+ years of related pharmaceutical experienceStrong knowledge of global regulatory and cGMP requirements, industry best-practicesStrong familiarity with production operations.Strong technical writing.Additional InformationPosition isfull-time, Monday-Friday, 8:00am-5:00pm.Candidates currently living within a commutable distance ofRensselaer, NYare encouraged to apply. Excellent full-time benefits including comprehensive medical coverage, dental, and vision options.Excellent full-time benefits including comprehensive medical coverage, dental, and vision optionsLife and disability insurance401(k) with company matchPaid vacation and holidaysEligibility for potential yearly Bonus & Merit-Based Pay IncreasesBase compensation is $19-$27 per hour based on experience.Eurofins is aM/F, Disabled, and Veteran Equal Employment Opportunity and Affirmative Action employer.
Compliance Specialist
Upbring, Katy
OverviewAbout Upbring At Upbring, we are servants on a mission to break the cycle of child abuse. We are warriors, brave as the thousands of Texas Children and families we serve. We stand up for those who can’t speak for themselves. We are a family who values innovation, empathy, patience, understanding and trustworthiness. About our Children's SheltersMany children begin life in the face of serious challenges. Instead of playing pretend and imagining grand adventures, unaccompanied children face perilous conditions alone as they travel to unfamiliar countries, leaving home and loved ones behind to escape war and violence. Our children’s centers, operated through a grant from the Office of Refugee and Resettlement (ORR), provide safety, stability and wraparound services. We help children grow into adults who have received love and kindness, instead of only violence and chaos. What You'll DoThe Compliance Specialist is responsible and accountable to ensure the program remains up-to-date on all regulatory and licensing requirements in accordance with agency, state, accreditation, and federal regulations. The Compliance Specialist develops, implements, and enforces policies and procedures that keep the agency’s services, processes, and physical sites operating in a legal and ethical manner. If there are suspected violations of compliance, the Compliance Specialist conducts audits or investigations, recommends areas for improvement, and develops roadmaps for remediation. Our Upbring staff members are servant-leaders in the pursuit of breaking the cycle of child abuse and empowering others to do the same through example while embodying our core values: We are Warriors. We are Servants. We are Family. All Upbring Children's Shelters employees must comply with ORR's vaccination mandate. All staff must be able to show proof of immunity to vaccine-preventable diseases transmitted by the respiratory route if working directly with unaccompanied children (UC). Medical and Religious exemptions may be requested after an offer of employment is accepted. ResponsibilitiesWe Are Warriors | We Set the Standards for Child Welfare Work Standards Maintain audit readiness by ongoing training, competency assessment, audit, monitoring or metrics and corrective actionPerform regulatory compliance safety walk-throughs of the program to ensure continuous complianceReview critical incident reports and carry out root analysis to determine the causeEnsure consistency in standards, processes, forms, and best care practices across all Upbring ORR Emergency Shelter programsMust be able to adjust quickly to different work situations and remain composed under pressure and in stressful situationsDesign, develop, implement, and evaluate interventions to improve performance for key indicators of program outcomes and business operations, goals, and objectives Analyze and evaluate the effectiveness of programs and operations in meeting established goals and objectives in compliance with Agency, licensing, accreditation, and other regulatory requirements and advise management on any non-compliance through detailed reports.Ensure that operations comply with legal regulatory standards, procedures, and policiesResponsible for monitoring and documenting compliance activities, advising leadership and management on compliance matters, and liaising with regulatory, accreditation, and government agenciesIdentifying, investigating, and reporting compliance issues, irregularities, and violations immediately to leadership and managementIdentify compliance issues and recommend solutions. Perform occasional regulatory training for employees with respect to applicable job functions or as a response to audit findingsAct as an internal resource for compliance related questions, issues, resolutions based on Agency policies and procedures, accreditation, and applicable government standardsAttend monthly program Safety Committee meetings All other duties as assignedCommunication Possess strong analytical thinking skills and be able to maintain meticulous records of compliance activitiesAbility to express and to communicate thoughts and ideas in a professional, clear, and concise manner, both orally and in written form to a variety of audiences and to all levels of staff.Must be willing to express and support management’s ideas to affected staffPossess the ability to tactfully and effectively work with collateral agencies, peers, and stakeholders to achieve the mission of the agency We Are Servants | We Help Others TeamworkAssist in coordinating audit materials for internal compliance audits and external regulatory and accreditation bodiesAssist with reviewing compliance related policies annually and recommend changes for management approval as neededAssist with reviewing and revising forms for compliance with applicable policies, procedures, and standards.Assist with the development of corrective action plans in response to audit discoveries and compliance violations Assist with assuring that all deficiencies noted in Compliance Reports are addressed adequately and in a timely mannerAssist with receiving, archiving, and distributing all compliance resources as neededHelps to build and promote teamworkBuild and maintain cooperative working relationships with management, program staff, inter-disciplinary teams, volunteers, and service providers to ensure the needs of the UC and program goals and services are being met at the highest quality We Are Family | We Are Passionate & Compassionate Building RelationshipsBuild and maintain cooperative working relationships with leadership, management, program staff, inter-disciplinary teams, volunteers, and service providers to ensure the needs of the UC and program goals and services are being met at the highest qualityWork as a team player and exhibit professional behavior and a positive attitude with both internal and external clients that reflects positively on the Agency and is consistent with Agency policies and proceduresActively participate in exhibiting cultural awareness and sensitivity when interacting with UC, staff, and the communityProjects a positive image always along with the ability to work well with othersQualificationsMinimum QualificationsBachelor’s degree in behavioral science, social services fields, or closely related field2-years’ experience working with compliance issues, auditing, data, policies, standards, and best practicesMust be 21 years of age or older per licensing requirementsBilingual (Spanish preferred due to service area and service population)Ability to use sound judgment and always maintain confidentiallyDemonstrated ability to establish trust and a positive rapport with the service populationDemonstrated ability to gather and analyze information and translate into empirical data (metrics, structured reporting, data driven analysis)Ability to create scorecards and dashboards with relevant information to influence strategic planning, decision making, and meet department, program, and Agency goals and objectivesStrong time management and organizational skills with the ability to manage competing priorities and meet deadlinesStrong interpersonal and people skills with the ability to work independently, within a team environment and with a diverse group of peopleProficient with Microsoft Word, Excel, Power Point and OutlookPreferred QualificationsMaster’s degree in behavioral sciences, social services fields, or closely related fieldsCertified Risk and Compliance Management Professional (CRCMP)Prior compliance and/or internal company audit experience in a role like quality assuranceAdvanced knowledge of Licensing minimum standards and Office of Refugee and Resettlement policiesPerks at UpbringCompetitive PTO & paid holidays Health, dental, vision insurance & more! 403(b) PlanEmployee Assistance Program24/7 access to telemedicine and counseling services Discounted Gym Memberships Donated Leave Program Physical Demands & Work ConditionsThis position requires sitting and looking and using a computer for extended periods of timePosition works in a child facility and has constant exposure to childrenLift, push, pull, and move up to 25 lbs. The physical requirements for this position with or without reasonable accommodation are representative of those that must be met by an employee to perform the essential functions of this position successfully. While performing this position the employee with or without reasonable accommodation should have the ability to walk, stand, sit, kneel, speak, and hear with aid, see, read, reach with arms and hands, lift and/or move up to specified weight, and use equipment that is essential to performing the job, such as a computer, copier, fax machine, telephone, and automobile, if applicable. Specific vision requirements of this position may include color vision, seeing things close up, and the ability to adjust focus. Diversity. Equity. Inclusion. Belonging  We are a diverse and inclusive Organization that recognizes our strength is in the efforts of our selfless warriors. Honoring and recognizing the value and dignity of all individuals is the cornerstone of our agency. The more diverse the individuals, thought processes and lived experiences, the greater the opportunity is to combine unique perspectives to make a greater impact. Our trust, respect, and appreciation for one another is demonstrated through our communication, celebration of progress and relentless effort to be at our best TO FULLFILL OUR MISSION OF BREAKING THE CYCLE OF CHILD ABUSE. Upbring is an Equal Employment Opportunity/AA Employer and does not discriminate on the basis of race, color, ancestry, religion, age, sex, sexual orientation, gender, gender expression, gender identity, pregnancy, marital status, national origin, genetic information, physical or mental disability, military or veteran status.PI239773934
Compliance Specialist
VOA Chesapeake, Baltimore
COMPANY OVERVIEW: Volunteers of America Chesapeake & Carolinas empowers self-reliance and inspires hope. As a church without walls, we do this through personalized housing, ministry, health, and human services that benefit vulnerable individuals, their families and the community. Founded in 1896 in Baltimore, MDby social reformers, Ballington and Maud Booth, we were one of the first of over 30 affiliates of Volunteers of America - one of the nation's largest and most comprehensive human services organizations. Our founders envisioned a movement dedicated to reaching and uplifting the American people. On behalf of the organization, the Booths pledged "to go wherever we are needed, and do whatever comes to hand". Their declaration continues to guide Volunteers of America's impact on "Helping America's most vulnerable". Through a dedicated and committed team of more than 850 employees and thousands of volunteers, we provide critical care, support services and hope to thousands of people each year throughout Virginia, Maryland, the District of Columbia and the Carolinas. We firmly believe our employees drive the success of the organization. Through our diversity, equity and inclusion efforts (DEI), we endeavor to attract, engage and retain qualified, diverse, compassionate individuals to join our journey and experience a work environment that offers challenging, stimulating and financially rewarding opportunities. JOB SUMMARY: The Compliance Specialist is responsible for ensuring that agency programs and services are implemented in accordance with federal, state, local and agency standards through various means, including compliance audits and reports. In addition, the Compliance Specialist is responsible for developing training programs, and conducting all required training for employees. RESPONSIBILITIES: Maintain complete knowledge of the agency policies and procedures (including operational procedures), BOP, QCP and ACA standards. Develop and implement internal audit systems, in order to provide timely monitoring and assessment of programs and facility services. Compile documentation for compliance reviews for all regulatory requirements (the American Correctional Association, Federal Bureau of Prisons, etc.) and other contracted entities under which services are provided. Conduct an internal audit in order to determine compliance with agency standards, documenting findings and assist in corrective action plans indicating specific time lines to comply with agency standards. Conduct a compliance audit of policies and procedures in accordance with ACA standards; monitor and review ACA Outcome Measures on a monthly basis. Review ACA audit reports and findings, if any, and assist in preparing agency responses for review and approval. Submit annual certification reports to ACA outlining facilities compliance level, current status of action plans, and significant events, as required. Provide comprehensive training program for current &/or newly hired employees throughout the program staff (e.g. agency program policies and procedures, program rules and regulations, BOP contract requirements, QCP, ACA standards, agency forms, report writing, correction & security protocols) &/or management staff (e.g., leadership, delegation, new/advanced management training). Schedule training sessions, request/arrange equipment (e.g., video, recording, teleconferencing); maintain attendance records, training calendar; schedule follow-up sessions as needed; Participate with co-workers as self-directed work team to discuss issues, findings, discuss new and/or improved training methods and techniques. Coordinate and/or participate in training (e.g., solicit relevant staff for participation, register participants, conduct training overview & content review) conducted by outside entities, or contracted agencies as needed; request/arrange equipment (e.g., video, recording, teleconferencing); schedule follow-up sessions as needed; participate with co-workers as self-directed work team to discuss issues, findings, new and/or improved training methods and techniques (e.g., Quality Assurance, Accreditation). Perform other duties as assigned. Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities and activities may change at any time with or without notice. EFFECT ON END RESULTS: To maintain an internal auditing system. To complete ongoing assessments of the program and services provided to the residents. To maintain documentation for compliance reviews. To maintain compliance audit of the agency policies and procedures, including operational procedures. To assist in maintaining compliance with contractors and regulatory requirements. To maintain a training curriculum for new and current staff. To facilitate staff development trainings for all new and current staff. PHYSICAL REQUIREMENTS: The physical requirements described below are representative of those that must be met by an employee to successfully perform the essential duties of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential duties. The ability to safely operate a motor vehicle to transport oneself, consumers, and program supplies as necessary. The physical ability to travel to assigned locations, stand, stoop, bend, reach, pull, push, lift, grasp, climb, talk, see, hear and perform basic and light home maintenance activities, and operate office equipment. Move and lift light objects up to 30 pounds such as mail, supplies, files, and equipment. Operating office equipment requiring continuous or repetitive hand/arm movements. The ability to remain in a sitting position for extended periods of time. OTHER DUTIES: Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities and activities may change at any time with or without notice. QualificationsREQUIREMENTS Bachelors Degree in a field of organizational administration, public administration, criminal justice, or management. Bachelors Degree in human services with at least two years of human services and/or corrections experience is acceptable. Reasonable combination of the following skills and abilities: organizational, time management, detail oriented, system development, written and verbal communication, interpret compliance requirements and public relations. The ability to multitask and function within a non-traditional work environment. The ability to be a self-started and work independently with limited supervision at times. Experience with Microsoft Word, Excel, Power-point, Outlook Email, and other systems i.e. electronic time punches, electronic medical records etc. Bilingual in any language a plus. EEO/AAGet job alerts by email. Sign up now!