Document Control & QA Specialist (QC / e
QMS / LIMS
/ Empower)
- (Contract)
- Onsite
- San Diego, CA Pharmaceutical organization seeks a Document Control & QA Specialist to manage QC documentation within a Quality Management System (eQMS) and provide QA oversight for QC laboratory operations, sample management, stability programs, and method transfer documentation.
Focus includes GxP compliance, ALCOA+ data integrity, inspection readiness, and governance of controlled documentation supporting a LIMS-enabled QC lab environment, including instrument integrations and method transfer activity into Waters Empower CDS. The ideal candidate will have 6+ years supporting FDA-regulated / GxP environment, and exposure to both LIMS and eQMSs. Opportunity provides an onsite 12-month contract for a qualified individual local to San Diego. Benefits"
Pay Range :
Up to $55/hr. (C2C)
Work Arrangement :
100% onsite in San Diego, CA (local candidates only)
Duration :
12-month contract (ASAP start; extension possible based on business needs)
Responsibilities:
QA Oversight of QC Laboratory, Sample Management, Stability, and Method Transfer Documentation Perform QA review and approval routing for QC procedures, sample management documentation, stability protocols, method transfer protocols, SOPs, and work instructions. Provide QA oversight of QC process documents and method transfer protocols to ensure alignment with internal quality governance expectations. Review/approve QC instrument qualification documentation when equipment is integrated with Empower and/or the LIMS. Ensure documentation and records meet ALCOA+ data integrity principles (Attributable, Legible, Contemporaneous, Original, Accurate, Complete, Enduring, Available) Ensure document lifecycle compliance within the eQMS (draft, review, approval, issuance, archival, periodic review) Provide QA governance over documentation supporting sample receipt, handling, storage, testing, and stability lifecycle activities. Support inspection readiness through QA oversight of QC documentation practices and data integrity compliance. SOP Authoring and Revision (QC Laboratory Processes) Author, revise, and review SOPs governing QC laboratory processes including sample management, stability testing, and method transfer. Ensure SOPs clearly define controlled laboratory practices and align with regulatory requirements and internal quality systems. Partner with QC, QA, and technical stakeholders to ensure procedures accurately reflect current laboratory operations. Ensure SOP updates are version-controlled, approved, implemented via eQMS, and paired to required training assignments. Maintain standardization across QC procedures to support consistent compliance and data integrity expectations. Document Control / Processing (eQMS) Initiate and manage document workflows within eQMS (draft, review, approval) Assign reviewers/approvers and manage effective dates. Issue and reconcile controlled documents and QC logbooks (as applicable) Maintain document archival and retrieval practices to support audit/inspection readiness. Monitor, drive, and close document change requests (DCRs) Support periodic review execution for controlled documents. Training (Quality System / QC Document Training) Assign training tied to new or revised QC and quality system documents. Develop and update training materials and challenge questions linked to SOPs (as required) Ensure training content remains aligned to currently approved procedures. Support alignment between document revisions and training completion requirements. LIMS & Laboratory Systems Support Operate in a LIMS-enabled QC laboratory environment with understanding of GxP controls, sample/data/instrument workflows, and traceability expectations. Support controlled processes for sample management, stability tracking, data integrity, and system-related documentation governance. Support method transfers documentation and instrument integration workflows, including Empower-related documentation needs.
Requirements:
Bachelor's degree in Chemistry, Biochemistry, Pharmaceutical Sciences, or a related scientific discipline 6+ years regulated industry experience supporting FDA-regulated / GxP environments. Demonstrated QA oversight experience in a QC laboratory environment, including sample management and stability processes. Hands-on experience authoring/revising SOPs governing laboratory processes (QC-focused) Strong knowledge of ALCOA+ and data integrity expectations Experience working within eQMS and LIMS environments. Experience supporting documentation related to method transfers and instrument integrations, including Waters Empower CDS
