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We're looking for a Quality Assurance Compliance Specialist IV
, working in Pharmaceuticals and Medical Products
industry in 100 College Street, New Haven, Connecticut, 06510, United States
- Assist in daily activities for the ongoing development and operations of the GMP Archive with Quality Assurance.
- Take the lead in carrying out the operational requirements that result from policies, procedures, regulations, and guidances governing the management of records that exist in print and electronic form.
- Help manage record retention schedules, outreach to other internal/external archival support staff, and the acquisition of GMP Archive records.
- Record control will be maintained at many levels, such as original hardcopies, electronic files, and physical security.
- Coordinate documents such as laboratory notebooks, binders, procedures, photographs, computer printouts, protocols, technical reports, resumes, audits, facility records, validation documents, and certificates of analysis.
- Contribute to the completion of milestones associated with specific projects and supports quality systems related to document reviews, training, change control, deviations, corrective actions/preventative actions, and investigations.
- Expedient retrieval of organized and complete records for internal requests, agency requests, and regulatory inspections is a key element to this position.
- Provide the incumbent the unique opportunity to lead in various areas of GMP Quality Systems.
Our client is an award-winning clinical development company. Improving lives globally with 20+ years experience in clinical research and strategic resourcing. Elevating results with proven strategies, comprehensive solutions, and customized delivery models.
Serving pharmaceutical, biopharmaceutical, biotechnology, and medical device organizations.
Strong relationships provide you connections and access to great opportunities. Industry expertise sets you up for success with helpful insights, career coaching, and professional training. Grow and learn while you put your skills to work.
Experience Required for Your Success
- 9+ years of Experience
- Ability to review documents for compliance to regulations, guidances, and internal procedures/policies
- Minimum of 7 years GMP related experience in biopharmaceutical / pharmaceutical or related industry
- Experience in developing, implementing, and evaluating archives or records management processes and systems. This includes cataloging, filing, and retrieving of records
- Experience with GMP global regulatory requirements
- Experience with electronic systems (e.g. FirstDoc and TrackWise) and databases
- Capable of moving, copying and recovering large numbers of files and folders in a Windows environment
What Do You Think?
Does your experience reflect what it takes to be successful in this role? Do the work and challenges get you excited about what's possible?