Quality Systems Specialist

Job Title: Quality Systems Specialist Job Description This role supports Quality Assurance operations in a GMP-regulated pharmaceutical manufacturing environment. The Quality Systems Specialist reviews and maintains critical quality documentation, supports batch disposition and release activities, and ensures compliance with regulatory standards. The position offers exposure to the full quality lifecycle, including batch record review, investigations, audits, and regulatory work, with responsibilities that scale based on experience level. Responsibilities Review batch production records, laboratory results, logbooks, and quality documentation to verify accuracy, completeness, and compliance with cGMP and Good Documentation Practices. Support batch disposition and release of raw materials, intermediates, and finished pharmaceutical products in alignment with regulatory and internal quality standards. Perform document control activities, including managing logbooks, standard operating procedures (SOPs), and quality records to ensure proper version control and traceability. Provide a visible Quality Assurance presence on the manufacturing floor by performing line clearances, in-process checks, and on-the-spot documentation reviews. Partner with Operations and other functional teams to resolve documentation or process-related issues in real time and prevent recurrence. Support investigations for deviations, non-conformances, CAPAs, and change controls within the quality system, contributing to root cause analysis and effective corrective and preventive actions. Assist with audit preparation, inspection readiness activities, and the compilation of regulatory documentation to support internal and external inspections. Maintain accurate Quality Assurance records in both paper-based and electronic systems, including ERP and other quality-related platforms. Collaborate cross-functionally with Manufacturing, Quality Control (QC), Engineering, Regulatory, and other stakeholders to ensure consistent quality practices and alignment. Contribute to the development, revision, and implementation of SOPs and quality documentation to support continuous improvement initiatives. Support peptide and API manufacturing activities by ensuring adherence to high-compliance standards and applicable regulations. Participate in or support internal and supplier audits as needed, helping to assess compliance and identify improvement opportunities. Essential Skills Strong understanding of cGMP requirements and quality compliance within a pharmaceutical manufacturing environment. Working knowledge of FDA, ICH, and EU regulations and the ability to ensure manufacturing, documentation, and release activities align with these standards. Hands‑on experience reviewing batch records, laboratory results, logbooks, and QA documentation for accuracy, completeness, and compliance with Good Documentation Practices (GDP). Experience supporting or leading investigations, deviations, non-conformances, CAPAs, and change controls within a GMP quality system. Quality Assurance experience in a GMP-regulated environment: 2–4 years for LevelI roles, 3–5 years for LevelII roles, and 5+ years for LevelIII roles. Bachelor’s degree in Chemistry, Biology, Engineering, or a related scientific or technical field. Strong attention to detail and organizational skills, with the ability to manage multiple tasks and priorities in a structured manner. Ability to work independently while appropriately escalating risks and issues when needed. Strong written and verbal communication skills for clear documentation and cross‑functional collaboration. Experience working in fast-paced manufacturing settings, balancing on‑floor support with documentation responsibilities. Additional Skills & Qualifications Experience with Quality Assurance activities related to APIs and peptide manufacturing. Exposure to or experience with ERP systems and electronic quality management tools. Experience participating in or supporting internal audits and supplier audits. Experience in developing, revising, or implementing SOPs and other controlled quality documents. Demonstrated ability to collaborate effectively with Manufacturing, QC, Engineering, and Regulatory teams. Job Type & Location This is a Contract to Hire 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 23, 2026. About Actalent Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 20,000 consultants and 5,000 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500. We are proud to be an Engineering News‑Record (ENR) Top 500 Design Firm for our engineering design services and a ClearlyRated Best of Staffing® winner for both client and talent service. 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. If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please email View email address on click.appcast.io for other accommodation options. 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