Quality Assurance Specialist

Quality Assurance Specialist (GMP) – Level I–III (DOE) We are seeking a detail-oriented Quality Assurance (QA) Specialist to support operations in a GMP-regulated pharmaceutical manufacturing environment. This role offers growth across multiple levels (I–III) based on experience and provides strong cross‑functional exposure in a fast-paced production setting. Key Responsibilities Review batch production records, laboratory results, and quality documentation to ensure GMP compliance Support batch disposition and release for raw materials, intermediates, and finished products Perform document control activities, including SOPs, logbooks, and quality records Provide QA oversight on the manufacturing floor: Line clearance In-process checks Partner with Operations and Manufacturing teams to resolve documentation and process issues in real time Assist with and/or lead: Deviation investigations CAPAs (Corrective and Preventive Actions) Non-conformances Change controls Support audit readiness, regulatory inspections, and related documentation Maintain accurate records across paper-based and electronic systems Collaborate cross‑functionally with QC, Engineering, Manufacturing, and Regulatory teams Contribute to SOP development, continuous improvement, and quality initiatives Required Qualifications Bachelor’s degree in Chemistry, Biology, Engineering, or related discipline QA experience in a GMP environment: Level I: 2–4 years Level II: 3–5 years Level III: 5+ years Strong knowledge of: GMP (Good Manufacturing Practices) GDP (Good Documentation Practices) Batch record review Experience with: Deviation management, CAPAs, and change controls Preferred Skills Experience in API, peptide, or pharmaceutical manufacturing environments Exposure to ERP systems and electronic quality systems Audit support or supplier audit experience Core Competencies Strong attention to detail and organizational skills Ability to work independently and escalate quality risks appropriately Excellent written and verbal communication Comfortable working in a fast-paced manufacturing environment Top Skills GMP Compliance Batch Record Review CAPA Management Deviation Investigations Change Control Job Type & Location This is a Contract position based out of San Diego, CA. Pay and Benefits The pay range for this position is $24.00 - $45.50/hr. Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following: Medical, dental & vision Critical Illness, Accident, and Hospital 401(k) Retirement Plan – Pre‑tax and Roth post‑tax contributions available Life Insurance (Voluntary Life & AD&D for the employee and dependents) Short and long‑term disability Health Spending Account (HSA) Transportation benefits Employee Assistance Program Time Off/Leave (PTO, Vacation or Sick Leave) Workplace Type This is a fully onsite position in San Diego, CA. Application Deadline This position is anticipated to close on Jun 17, 2026. Equal Opportunity Employer The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law. San Francisco Fair Chance Ordinance Pursuant to the San Francisco Fair Chance Ordinance, for all positions located in the city and county of San Francisco, we will consider for employment qualified applicants with arrest and conviction records. Massachusetts Lie Detector It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability. Use of Artificial Intelligence (AI) We may use Artificial Intelligence (AI) to support parts of our hiring process, including sourcing, screening, and evaluating candidates. AI helps assess applications and qualifications, but final decisions are made by our hiring team. By applying, you acknowledge and agree that your application may be reviewed using AI tools. #J-18808-Ljbffr