Description
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 .
Job description:
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.
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