QA Specialist

Job Title: QA Specialist

Job Description

The QA Specialist supports all elements of the quality system to ensure compliance with FDA cGMP and other applicable quality standards, with a primary focus on Supplier Quality. This role manages supplier qualification activities, oversees supplier-related quality documentation, and collaborates closely with internal and external stakeholders to maintain robust, audit-ready quality systems within a pharmaceutical environment.

Responsibilities

• Support all quality system elements to ensure compliance with FDA cGMP and other relevant quality standards, with an emphasis on Supplier Quality.

• Manage supplier qualification activities for new and existing suppliers, ensuring they meet internal and regulatory requirements.

• Coordinate supplier onboarding through the development and review of supplier qualification questionnaires, quality agreements, paper audits, and supporting documentation.

• Review, process, and support supplier-related change controls, ensuring appropriate assessment, documentation, and implementation.

• Assess supplier quality documentation to verify compliance with internal quality requirements and regulatory expectations.

• Support the qualification of suppliers providing APIs, raw materials, components, packaging materials, bottles, pails, bags, contract manufacturing services (CMOs), and external laboratory services.

• Track and manage supplier qualification projects from initiation through approval, maintaining clear timelines and status updates.

• Communicate directly with suppliers regarding qualification requirements, documentation requests, and quality-related inquiries.

• Support supplier risk assessments and supplier quality evaluations to identify and mitigate potential quality risks.

• Participate in supplier audit preparation and follow-up activities, including documentation review and paper-based audits.

• Maintain supplier qualification records and ensure all documentation is complete, accurate, and audit-ready.

• Collaborate with internal stakeholders to resolve supplier quality issues and support continuous improvement initiatives within the quality system.

• Assist with Annual Product Reviews (APRs) and related quality documentation, as applicable.

• Contribute to the overall effectiveness of Quality Assurance and Quality Systems by supporting activities such as change control, label control, APRs, and other quality system processes.

Essential Skills

• 3+ years of experience in a FDA-regulated pharmaceutical facility preferred.

• 3+ years of experience in Quality Assurance and/or Quality Systems.

• Demonstrated exposure to and experience with Quality Systems, preferably including Supplier Quality, Change Control, Label Control, and Annual Product Reviews.

• Strong experience in supplier qualification, including hands-on work with supplier qualification questionnaires, quality agreements, change controls, paper-based audits, supplier documentation, and qualification requirements.

• Knowledge of Annual Product Reviews (APRs) and related processes.

• Experience working in a pharmaceutical environment with an understanding of regulatory expectations and quality standards.

• Familiarity with quality systems management, supplier quality, auditing practices, and quality management principles.

• Proficiency in MS Office tools, including Word, Excel, and Outlook.

• Strong verbal, written, and electronic communication skills to effectively interact with suppliers and internal stakeholders.

• Ability to manage multiple supplier qualification projects and documentation in an organized, detail-oriented, and audit-ready manner.

Additional Skills & Qualifications

• Bachelors degree strongly preferred.

• Degree in Biology, Chemistry, or a related scientific field preferred.

• Experience with regulatory submissions and regulatory affairs is beneficial.

• Experience working with CMOs and external laboratories is an advantage.

• Strong customer focus, integrity, and commitment to safety and compliance.

• Demonstrated ability to collaborate effectively within cross-functional teams.

• Proven track record of achieving results in a quality-focused environment.

• Interest in learning multiple areas of quality systems and expanding expertise within Quality Assurance.

Job Type & Location

This is a Contract to Hire position based out of St. Louis, MO.

Pay and Benefits

The pay range for this position is $26.44 - $34.00/hr.

Individual compensation offered for this position within this range will depend on many factors, including qualifications, skills, relevant experience, job knowledge, geographic location, internal equity, and other pertinent job-related factors.

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)

Job Type & Location

This is a Contract to Hire position based out of St. Louis, MO.

Application Deadline

This position is anticipated to close on Nov 13, 2026.

Workplace Type

This is a fully onsite position in St. Louis,MO.

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 [email protected] 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.