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Sr. Document Control QA Specialist
- Permanent
- Senior/Director & VP, Good Distribution Practice (GDP), Good Pharmacovigilance Practice (GVP)
- United States
This vacancy has now expired. Please see similar roles below...
Proclinical is working with our client on an exciting opportunity to join a growing biotech company in San Diego! This isn't your average Document Control position; this role will wear many hats and be trained in several areas of QA! This position will require being onsite in the San Diego (Mira Mesa) office. It is a hybrid schedule, 3 days in office/2 days work from home. Please do not apply if you want a remote only position.
Job Responsibilities:
- Associate's degree or higher, Bachelor's degree preferred
- Manage document control, deviations and change control and training processes for GXP activities.
- Support audit scheduling and records for all GXP activities.
- Prepare and handle documents and procedures for review, approval, and execution.
- Develop, review and revise documentation procedures.
- Establish and maintain records management process including scan, storage, archival and retention.
- Support deviation and change control activities to ensure timely approval and closure.
- Oversee on boarding and on-going training program, tracking and maintaining training records
Skills and Requirements:
- Knowledge of GXP and GDP regulatory requirements.
- Strong collaboration, strategic thinking, leadership, and teamwork skills.
- EDMS experience
If you are having difficulty in applying or if you have any questions, please contact Jax Zafrani at (+1) 213-893-4997 or j.zafrani@proclinical.com.
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
Proclinical Staffing is an equal opportunity employer.
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