QA Specialist II​/III

Pay Rate Low: 39 | Pay Rate High: 58

A growing manufacturer of drug substances is seeking a Quality Assurance Specialist to join its QA team. This opening is being filled at one of two levels —
Level II or Level III — with placement determined by the candidate's experience and demonstrated capabilities.

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 for Level II
: $39-$52/hour,
Level III
: $44-$58/hour

• 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

• Perform timely, high-accuracy real-time batch record review and execute usage decisions within electronic batch release systems, including critical review of chromatographic data packages (HPLC, UPLC, GC) generated by QC in support of batch disposition
• Identify and put in place improvements to quality systems and SOPs, applying LEAN GMP principles
• Review and approve the full range of GMP documentation, including batch production records, validation protocols, analytical data, and reports
• Partner with other functions and sites to close out quality records and investigations (e.g., OOS) and to approve documents and changes such as master batch records, analytical procedures, protocols, reports, and specification
• Conduct internal GMP audits, drive compliance improvements, and advise other departments and sites on GMP compliance

• 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

• 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-related field with a minimum of 5 years in a GMP manufacturing setting, or
• Associate's degree in a science-related field with a minimum of 7 years in a GMP manufacturing setting
• 4–6 years in Quality Assurance
• 4–6 years working in an ISO 7 and ISO 8 controlled environment, supporting real-time batch record review
• 4–6 years with GMP document control, validation, qualification, and calibration (preferred)
• 4–6 years in internal auditing and in working with regulatory agencies (preferred)
• De…