Document Control Specialist II

Document Control Specialist II A growing manufacturer of drug substances is seeking a Document Control Specialist II to join its QA team. In this role you will help ensure that drug substances are produced in compliance with FDA and international regulatory requirements across research, pre-clinical, clinical, and commercial stages. The position centers on the review and processing of GMP documentation, day-to-day quality oversight, guidance to other functions on cGMP matters, and support for customer and regulatory audits. You will also help maintain GMP records and the supporting electronic quality systems. Location : Onsite in Vista, CA | Hours : M-F 8-5 | Type : 1-year contract | Compensation : $39-52/hour Core Responsibilities Carry out clearance verifications for production rooms, the dispensary, and shipments as needed Revise standard operating procedures (SOPs) and other GMP documents such as stability protocols, raw material specifications, and environmental monitoring trend reports Administer GMP documentation and the associated workflows for the department Review and verify QC data output from chromatographic systems (HPLC, UPLC, or GC), confirming the accuracy of scanned batch records, chromatograms, and associated analytical records, and ensuring documents are correctly labeled and packaged for archival Provide support during regulatory, customer, and internal audits Help implement and maintain the Quality Management System Scan, verify, and archive internal and external GMP records Represent QA on cross-functional and cross-site projects, including system and process harmonization and the rollout of new systems Education & Experience Bachelor's degree in organic chemistry or a related field required; master's degree in organic chemistry or a related field preferred, or Bachelor's degree in a science or related field with a minimum of 3 years in a GMP/manufacturing setting, or Associate's degree in a science or related field with a minimum of 5 years in a GMP/manufacturing setting 3-5 years in Quality Assurance and/or Quality Control 3-5 years in internal auditing and in working with regulatory agencies 3-5 years in an ISO 7 and ISO 8 controlled environment, with experience supporting real-time batch record review Demonstrated experience reviewing QC chromatographic data output from HPLC, UPLC, or GC systems in a GMP environment Knowledge & Skills Working knowledge of cGMP and FDA regulations and guidance Familiarity with Quality Management Systems and GxP Ability to review scanned batch records and QC chromatographic data output (HPLC, UPLC, or GC) with a high degree of accuracy Detail-oriented, with sound problem-solving and troubleshooting ability Able to work independently, manage your own time, and contribute effectively within a team Certifications ASQ Certified Quality Process Analyst, or Certified Quality Auditor (CQA), or Certified Quality Engineer (CQE) Pay Rate Low: 39 | Pay Rate High: 52 #J-18808-Ljbffr