Document Control & QA Specialist (QC labs)

Introduction

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.

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

Nice-to-have Skills & Qualifications

• 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