Overview
QA Specialist II/III Jobs in Vista, CA at Astrix
Title: QA Specialist II/III
Company: Astrix
Location: Vista, CA
Pay Rate Low: 39 | Pay Rate High: 58
Quality Assurance Specialist (Level II / Level III)
Position Summary
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
What You Will Do
Level II — 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.
- Confirm the accuracy of scanned batch records, chromatograms, and similar records, and ensure 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.
Level III — Additional Responsibilities
In addition to all duties at Level I and II, the Level III specialist will:
- Perform timely, high-accuracy real-time batch record review and execute usage decisions within electronic batch release systems.
- 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, 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 specifications.
- Resolve issues within GMP systems and serve as a resource on GMP topics.
- Help build the organization's quality culture through guidance and training of other departments and sites.
- Conduct internal GMP audits, drive compliance improvements, and advise other departments and sites on GMP compliance.
Qualifications
Education & Experience
Level II
- 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
Level III
- 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)
Knowledge & Skills (Both Levels)
- Working knowledge of cGMP and FDA regulations and guidance
- Familiarity with Quality Management Systems and GxP
- Ability to review scanned batch records and chromatograms with a high degree of accuracy
- Proficiency with Microsoft Word, Excel, and PowerPoint
- Strong written and verbal communication, with a proactive, solution-oriented approach that keeps management informed of potential issues
- Detail-oriented, with sound problem-solving and troubleshooting ability
- Able to organize, multitask, and perform in a fast-paced, deadline-driven environment
- Able to work independently, manage your own time, and contribute effectively within a team
Certifications (Preferred For Both Levels)
- ASQ Certified Quality Process Analyst, or
- Certified Quality Auditor (CQA), or
- Certified Quality Engineer (CQE)
This job description is a complete list of all desired skills, but not all are required. We strongly encourage candidates who have some of the skills to apply. We look forward to a conversation to learn more about you!
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