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Description

Position Summary: The Quality Assurance Specialist is responsible for ensuring compliance with Good Manufacturing Practices (GMP) and supporting manufacturing operations through documentation review, product disposition, and real-time quality oversight. This role plays a key part in maintaining product integrity and regulatory compliance across production campaigns. Key Responsibilities: Manufacturing Oversight: Provide support for room clearance activities prior to and during manufacturing operations. Offer on-the-floor and on-call QA support during manufacturing campaigns for PDS Products, PDS Services, and MDS. Issue and reconcile product labels in accordance with GMP requirements. Documentation & Disposition: Review production campaign documentation and batch records for completeness and accuracy. Perform final disposition of finished products, raw materials, and fill/finish components. Review cleanroom logbooks and ensure proper documentation practices. Quality Systems Management: Update, review, and approve QMS documentation (SOPs, work instructions, forms, specifications) using the Regulus document control system. Support SAP-related QA activities, including inspection plan reviews. Facility & Utility Monitoring: Review data supporting the testing of site utilities (e.g., WFI, steam, nitrogen). Conduct monthly GMP monitoring of laboratories, manufacturing areas, and warehouse facilities.

Skills

quality assurance, gmp, quality control, chemistry, sap, quality management system

Top Skills Details

quality assurance,gmp,quality control,chemistry,sap,quality management system

Additional Skills & Qualifications

Qualifications: Bachelor’s degree in Life Sciences, Chemistry, Engineering, or related field. 2+ years of experience in a GMP-regulated QA role within pharmaceutical or biotech manufacturing. Strong knowledge of batch record review, product disposition, and quality systems. Familiarity with SAP and electronic document control systems (e.g., Regulus). Excellent attention to detail, communication, and organizational skills.

Experience Level

Entry Level

Pay and Benefits

The pay range for this position is $33.00 - $36.00/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 Birmingham,AL.

Application Deadline

This position is anticipated to close on Jul 30, 2025.

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 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.

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 due to a disability, please email [email protected] (%[email protected]) for other accommodation options.