- Liaises with relevant functional groups (Operations, Facilitates, QC, EH&S) to provide guidance through all stages of the investigation / CAPA processes.
- Develops and communicates investigation strategy to key stakeholders.
- In order to close investigation and CAPA, collect necessary information from appropriate department to close in quality system and maintain investigation and CAPA log
- Reviews and approves investigations and CAPAs;
- Conducts weekly status update meetings with cross functional departments and other stakeholders.
- Monitors DR/CAPA KPIs including reporting requirements, provide detailed updates and information in support of quality & business review to management on periodic basis.
- Prepares and issues change control as necessary.
- Adherences and champions to all compliance regulations as required by regulatory agencies and per the Company's processes and procedures.
- Ensures appropriate CAPAs are generated to increase compliance and prevent repeat occurrences of deviations.
- Conducts trend analysis of compliance related metrics such as deviations and CAPAs.
- Performs supplemental investigations and/or participates in project teams or assignment as necessary.
- Support in agency, internal and/or client audits.
- Functional/Technical Skills: has the functional and technical knowledge and skills to do the job at a high level of accomplishment.
- Decision Quality: Makes good decisions (without considering how much time it takes) based upon a mixture of analysis, wisdom, experience, and judgment; most of his/her solutions and suggestions turn out to be correct and accurate when judged over time; sought out by others for advice and solutions.
- Drive for Results: Can be counted on to exceed goals successfully; is constantly and consistently one of the top performers; very bottom-line oriented; steadfastly pushes self and others for results.
- Written Communication: Able to write clearly and succinctly in a variety of communication settings and styles.
- Peer Relationships: Quickly find common ground and solve problems for the good of all; can represent his/her own interests and yet be fair to other groups; can solve problems with peers with a minimum of noise; is seen as a team player and is cooperative; easily gains trust and support of peers; encourages collaboration; can be candid with peers.
- BS biological sciences or other relevant field of study.
- 5 years' + experience in QA in a life sciences company with a strong focus in the manufacturing and/or testing of biologics preferred.
- Experience in authoring, reviewing, and /or approving cGMP/cGTP related documents (Investigation report, CAPA report, SOPs etc.) required.
- Understanding of quality system applications, including the use of electronic applications for training, deviations, CAPA management, etc.
- Familiar with FDA, ISO, and other regulatory agency guidelines.
- Understanding of Good Manufacturing Practices (GMP), Good Documentation Practices (GDP) and Good Laboratory Practices (GLP) required.
- Working knowledge and technical understanding of aseptic manufacture of biologics preferred.
- Experience in both clinical and commercial manufacturing is preferred.
- Experience in supporting health authority inspections and/or client audits preferred.
- Minimum Required Training (optional); GXP training, SOP & WI training, Safety Training
- Understanding and comprehension of quality system applications.
-
Specialist in Compliance
3 weeks ago
NebulaWorks Clifton, United StatesA publicly listed German reinsurance company specializing in various areas of property and casualty and life reinsurance is seeking a Compliance Management System Specialist (m/f/d). You will benefit from a pleasant working environment and numerous development opportunities. · Yo ...
-
Environmental Compliance Specialist
1 week ago
EmployVision Bergen County, NJ, United States**Environmental Specialist** · **Bergen County, NJ** · **Job Description-** · This role is responsible for ensuring compliance and coordinating efforts related to TSCA (PMN, LVE preparation/NOC submittals) and DSL compliance. Also ensure that additional regulatory practices are i ...
-
Document Compliance Specialist
1 week ago
Independent Chemical Corporation Paterson, United StatesRole & Responsibilities: · 1. Document Compliance Specialist is required to ensure that · product support and compliance documentation is current and complete in order · to facilitate timely resolution of internal and external customer requests and · concerns regarding chemical p ...
-
Quality Assurance Compliance Specialist
1 week ago
Json South Hackensack, United States**Summary**: This position will be responsible for working with QC and other departments to coordinate acceptable outcomes on distributor quality complaints. Effectively execute company processes while researching claims and project situations, in reaching project resolution. Ass ...
-
Compliance Specialist
2 weeks ago
ADAPT Community Network New York, United States**Why Join ADAPT?** · It's more than a job; it's a calling. It's where passion meets purpose. ADAPT Community Network, formerly United Cerebral Palsy (UCP) of NYC provides a multitude of services to people with developmental disabilities. At ADAPT, we are 3,000 strong, and it tak ...
-
Compliance Specialist
2 weeks ago
New York City Housing Development Corporation (HDC) New York, United States· **Position Summary**: · The Compliance Specialist reports to the Assistant Vice President of Compliance and is responsible for monitoring and evaluating compliance within HDC's Low Income Housing Tax Credit (LIHTC), Tax Exempt Bond (TEB), and Taxable Bond (TB) properties. · ** ...
-
Compliance Specialist
2 weeks ago
WB Residential Communities, Inc. Chappaqua, United States**Compliance Specialist** · **Duties**: · - Update waiting list and ensure accurate notes. · - Understands income limit requirements & rent charges with applicant households. · - Conducts applicant background checks & hold applicant interviews to prepare initial Tenant Certificat ...
-
Compliance Specialist
1 day ago
Sun River Health Manhattan, United StatesSun River Health provides the highest quality of comprehensive primary, preventative and behavioral health services to all who seek it, regardless of insurance status and ability to pay, especially for the underserved and vulnerable. Sun River Health is a Federally Qualified, Non ...
-
Compliance Specialist
11 hours ago
MMC Corporate New York, United StatesMercer, a place where extraordinary individuals can do their best work and lead their best lives We believe in camaraderie and collaboration, no matter what your role, level, experience or background. · **Compliance Specialist** · **What can you expect?** · - The team at Mercer w ...
-
Compliance Specialist
3 weeks ago
Lee Hecht Harrison Nederland B.V. Rochelle Park, United States9-5 · Long term temporary role · Filings,database updates, reconcile billing for Public notice · High level of coordination · Working directly with our client's real estate team's development. · 100% on site · Pay Details: · $20.00 to $22.00 per hour · Search managed by: · ...
-
Academic and Compliance Specialist
3 weeks ago
Eastern International College Jersey City, United StatesThe Academic and Compliance Specialist (ACS) leads and coordinates the development of new academic programs and ensures regulatory compliance with State and accreditation standards and procedures. The ACS also coordinates, formulates, and conducts faculty professional development ...
-
Medicare Compliance Specialist
1 week ago
MetroPlusHealth New York, United States**Empower. Unite. Care.**: · **MetroPlusHealth** is committed to empowering New Yorkers by uniting communities through care. We believe that Health care is a right, not a privilege. If you have compassion and a collaborative spirit, work with us. You can come to work being proud ...
-
Contract and Compliance Specialist
2 weeks ago
Upwardly Global New York, United States**Title: Contract and Compliance Specialist** · **Department: Finance** · **Reports to: Director of Budget and Grants Compliance** · **Location: New York, San Francisco, Chicago or DC** · **FLSA Status: Exempt** · **About the Organization** · Over the years, Upwardly Global has s ...
-
HR Compliance Specialist
3 weeks ago
The College Board New York, United StatesHR Compliance Specialist (temp) · - College Board - Global Strategy & Talent- work location · - is regularly commutable for you. · Type: This is a temp position expected to last 3-6 months from the start date · - Anticipated Start date: May 7 · - About the Team · - The Talent tea ...
-
BMW Woodcliff Lake, United StatesAs an independent group of companies, the BMW Group has a commitment to creativity and breakthrough ideas that goes well beyond the racetrack. In order to continuously create ultimate driving machines, we drive our growth and design excellence by staffing our teams with individua ...
-
Compliance and Audit Specialist
1 week ago
DocGo New York, United StatesTITLE: COMPLIANCE & AUDIT SPECIALIST · - SALARY: $72,500-$82,000 · - LOCATION: DocGo HQ, 35 W 35th St. New York, NY 10001 · - EMPLOYMENT TYPE: Full Time, On-Site · - BENEFITS: Medical, Dental, and Vision (with company contribution), Paid Time Off, 401k · ABOUT DOCGO: · - DocGo is ...
-
Environmental Compliance Specialist
3 weeks ago
FMC Corporation Newark, United StatesFMC Corporation is a global agricultural sciences company dedicated to helping growers produce food, feed, fiber and fuel for an expanding world population while adapting to a changing environment. FMC's innovative crop protection solutions - including biologicals, crop nutrition ...
-
Lead HR Compliance Specialist
3 weeks ago
Starbucks New York, United States**Now Brewing - Lead HR Compliance Specialist -#tobeapartner** · **From the beginning, Starbucks set out to be a different kind of company**. One that not only celebrated coffee and its rich tradition but also brought a feeling of connection. We are known for developing and suppo ...
-
Wealth Management Compliance Specialist
3 weeks ago
EF Hutton New York, United States**The Company** · EF Hutton is a fast-paced, high-growth, global investment bank founded by experienced investment professionals that have collectively financed over $250 billion for public and private companies alike. EF Hutton offers strategic advice and financing solutions to ...
-
Saint Dominic's Family Services Blauvelt, United StatesThe Compliance Specialist, Developmental Disabilities is responsible for the tracking and collecting all developmental disabilities data/reports related to accountability services and will be responsible for supporting incident management practices across all OPWDD programs. · ** ...