Overview
Document Control & QA Specialist (QC labs) Jobs in San Diego, CA at The Planet Group
Title: Document Control & QA Specialist (QC labs)
Company: The Planet Group
Location: San Diego, CA
Job Title: Document Control & QA Specialist (QC Labs) – (eQMS / LIMS / Empower) – Contract
Location: San Diego, CA
Onsite Requirements: Fully Onsite (100% onsite; local candidates only)
Compensation Range: $35/hr. W2 (w/wo benefits) $55/hr. (C2C)
Benefits: Not specifiedIntroduction
- A pharmaceutical organization is seeking a Document Control & QA Specialist to manage QC documentation within an electronic Quality Management System (eQMS) and provide Quality Assurance (QA) oversight for QC laboratory operations.
- This role supports sample management, stability programs, and method transfer documentation in a LIMS-enabled environment, including analytical instrument integrations and method transfer activity into Waters Empower (CDS).
- The position emphasizes GxP compliance, ALCOA+ data integrity, and inspection readiness.
Day-to-Day Responsibilities
- Perform QA review/approval routing for QC procedures, sample management documentation, stability protocols, method transfer protocols, SOPs, and work instructions
- Provide QA oversight for QC process documents, method transfer documentation, and instrument qualification documentation (when integrated with Empower and/or LIMS)
- Ensure document lifecycle compliance within the eQMS (draft, review, approval, issuance, archival, periodic review) and support inspection readiness
- Author, revise, and standardize QC SOPs (sample management, stability testing, and method transfer), and ensure training is assigned/aligned to approved procedures
- Initiate and manage document workflows; assign reviewers/approvers, manage effective dates, issue/reconcile controlled documents/logbooks (as applicable), and drive document change requests (DCRs) to closure
- Support controlled processes for sample traceability, stability lifecycle activities, data integrity, and laboratory system documentation governance in a LIMS-enabled QC environment
Required Skills & Qualifications
- Must-have qualifications that candidates must meet to be considered.
- Bachelor’s degree in Chemistry, Biochemistry, Pharmaceutical Sciences, or a related discipline
- 6+ years (or comparable) experience in an FDA-regulated / GxP environment with QA oversight in a QC laboratory setting (including sample management and stability processes)
- Hands-on experience authoring/revising QC-focused SOPs, strong knowledge of ALCOA+ data integrity, and experience working in eQMS and LIMS environments
Preferred Skills & Qualifications
- Nice-to-have skills that would make a candidate more competitive but are not required.
- Experience supporting documentation related to method transfers and instrument integrations
- Direct experience with Waters Empower CDS in a QC documentation / compliance context
- Experience developing/updating training materials and/or challenge questions tied to SOPs
#TECH
Onsite:
