Sr. Specialist Quality Assurance - Contract - San Diego CA
Proclinical is seeking a Sr. Specialist Quality Assurance to oversee and manage document control activities, including deviations, change control, training, and maintenance of documents.
Primary Responsibilities :
This role involves managing and archiving quality-controlled documents and records for GMP, GLP, and GCP. The successful candidate will also support GXP managers in creating training matrices for new employees and maintain training records.
This role will also maintain the approved supplier list and participate in batch record reviews and approvals.
Skills & Requirements :
- Knowledge of GMP, GCP, and GDP regulatory requirements.
- Experience with EDMS or EQMS is preferred.
- Self-motivated with excellent organizational skills and the ability to prioritize effectively.
- Ability to work and make decisions independently and as part of a team.
- Strong verbal, interpersonal, and written communication skills.
- Strong collaboration, strategic thinking, leadership, and teamwork skills.
- Advanced computer skills.
The Sr. Specialist Quality Assurance's responsibilities will be :
- Manage document control, change control, and training processes for GXP activities.
- Prepare and handle documents and procedures for review, approval, and execution.
- Develop, review, and revise documentation procedures.
- Establish and maintain records management processes, including archival and retention of key documents and protocols.
- Ensure operational and validation status of EQMS and DocuSign Part 11 systems.
- Handle and track change control activities, ensuring timely approval and closure.
- Oversee onboarding and ongoing training programs, tracking and maintaining training records.
- Recommend improvements and changes to quality processes.
- Attend CMC and Clinical Sub team meetings as a QA representative.
- Help prepare metrics information for GMP using EQMS summary functions.
- Perform other duties as assigned.
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