Quality Assurance Specialist

Our client is a pillar in the Chemical Manufacturing industry that supports Pharma, Biopharma, and Biotech subsets with its production of materials. We are seeking a new QA Specialist to help their growing team!

Located in St. Louis, MO

6 month contract to hire
Pay: $30-36/hour
1st shift

Key Responsibilities:

• Operate within a GMP-regulated environment to support and implement quality-related activities.

• Interpret and apply regulatory guidelines, policies, and industry best practices to ensure compliance across departments.

• Serve as a subject matter expert and primary QA contact for quality and operational systems.

• Review and approve procedures, protocols, technical specifications, and reports to ensure alignment with internal and regulatory requirements.

• Author and maintain Standard Operating Procedures (SOPs), validation plans, and other compliance documentation.

• Oversee validation documentation including user and functional requirements, IQ/OQ/PQ, risk assessments, and traceability matrices.

• Conduct reviews and audits of computerized systems in accordance with 21 CFR Part 11, Annex 11, and other applicable regulations.

• Lead qualification activities for instruments, equipment, cleanrooms, facilities, and computer systems.

• Perform periodic reviews of validation and qualification records to ensure ongoing compliance.

• Maintain accurate, audit-ready documentation following Good Documentation Practices and Data Integrity standards.

• Drive continuous improvement initiatives to enhance quality systems and ensure regulatory alignment.

• Support food safety and quality certification programs (e.g., HACCP, FSSC 22000).

• Conduct internal audits and self-inspections across various departments including QC, manufacturing, and warehousing.

• Present quality metrics and findings in departmental and cross-functional meetings.

• Collaborate with cross-functional teams to promote and enforce site-wide quality standards.

• Review and approve change controls, ensuring compliance with all relevant standards and procedures.

• Conduct and document GMP-related risk assessments.

• Administer and maintain Quality Management Software systems.

• Perform additional quality activities as needed in alignment with business priorities.

Qualifications:

• Bachelor’s degree in a scientific discipline such as Chemistry, Biology, Biochemistry, or Microbiology.
• Minimum of 5 years of progressive Quality Assurance experience in a GMP-regulated pharmaceutical or biopharmaceutical environment, preferably with a focus on Active Pharmaceutical Ingredient (API) manufacturing.