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Quality Assurance Documentation Specialist
Job Description
- Review and verify document records to ensure the documentation complies with regulations and internal quality control practices.
- Request, organize and maintain raw material and supplier documents.
- Maintain files and retrieve requested documents during inspections, audits, traceability exercises, recalls, market withdrawals, business continuity, etc.
- Participate in customer audits by completing pre-audit questionnaires, presenting specific programs, contributing to and following up on corrective actions, as needed.
- The Document Control Specialist will author, format, track, store, review, update and maintain control over all Quality Assurance documentation.
- Leads customer complaints, contributing to and following up on corrective actions, as needed.
- Obtain Vendor Audit questionnaires from hundreds of suppliers to ensure they comply with FSVP.
Job Requirements
- Strong quality documentation background, preferably in a GMP setting, such as a nutraceutical, food, or dietary supplement manufacturer
- Minimum Bachelor of Science degree
- Excellent organizational skills
- Excellent communication and problem-solving skills
- Strong experience with the documentation area (ex. product related documents such as SIDI documents).
- Experience with third party audits+
Meet Your Recruiter
Matthew Assael
Matt Assael heads up a team focused on Management level to C Suite searches in the Life Sciences industry. He is a staffing industry veteran with 30+ years in Executive Recruitment; 29 years in Life Sciences. Matt has worked extensively in the Precision/Personalized Medicine area including Cell and Gene Therapy, Molecular Diagnostics, Gene Editing and Next Generation Sequencing. He began working in this niche specialty area approximately 20 years ago when he first became interested in Precision/Personalized Medicine for the Pharma/Biotech industries. Matt predicted that this novel approach to treating disease was going to lead to a medical revolution and he wanted to be a part of this new specialty’s growth. Matt focuses on leadership talent in areas such as Discovery Research (Principal Scientist through the Head of R&D), Biomarker Research, Translational Research, Bioinformatics, Computational Biology, Clinical Development, Medical Affairs, MSLs, Medical Information, Pharmacovigilance/Safety Surveillance, Regulatory Affairs, Biostatistics/Data Management, Quality Systems/Manufacturing, Sales and Marketing and Business Development. #LIVINGLLOYD
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