QA/Regulatory Specialist (Chemical Manufacturing)

Astrix • Saint Louis, MO

255d • $65,000 - $75,000

About The Position

Our client, a global leader in cGMP manufacturing of high purity specialty chemicals for pharmaceutical, biotech, nutritional, food and other markets, is seeking a Quality Assurance Specialist to join their team! The Quality Assurance (QA) Specialist is responsible for ensuring that all products and processes meet established standards of quality, including reliability, usability, and performance. This role involves developing, implementing, and maintaining quality assurance systems and activities to ensure compliance with regulatory requirements and internal standards. The QA Specialist will work closely with cross-functional teams, including manufacturing, regulatory affairs, and R&D, to support continuous improvement initiatives and ensure product safety and efficacy.

Requirements

• A Bachelor's Degree is essential, preferably in a relevant scientific field like Chemistry, Biology, Biochemistry, or Microbiology.
• Preferred at least 5 years of experience in the biopharmaceutical industry, with progressive involvement in Quality Assurance cGMP experience in the area of Active Pharmaceutical Ingredients (API) manufacturing or related industrial experience.
• Exceptional written and verbal communication abilities.
• Knowledgeable in instrument, equipment, facility, clean rooms and software qualification - validation.
• Experienced in auditing suppliers, analytical contract labs and vendors.
• Knowledge of annual product review and stability study protocols per ICH.
• High level of knowledge in cGMP guidelines as specified in ICH Q7A.
• Working knowledge of 21 CFR Parts 11, 210, and 211.
• Experience conducting audits of internal and external operations preferred.
• Certification as a Quality Auditor or an equivalent qualification preferred.
• Proficiency in computer operations, including experience with SAP and various reporting and data analysis tools such as Word, Excel, Visio, JMP, and Minitab.

Responsibilities

• Provide QA support and be a primary point of contact for quality systems and other operational systems, provide oversight of systems to ensure compliance with internal policies, procedures, and guidelines.
• Review and approve procedures and documents against regulatory and internal requirements to include protocols, technical specifications, raw data, final reports.
• Author SOP's, protocols, validation plans and compliance documents for cGMP program.
• Author and review validation documentation - such as user requirements, functional requirements, validation plans, IQ/OQ/PQ documentation, risk assessments, test scripts, trace matrix Review.
• Review and audit computerized system validation deliverables according to 21 CFR Part 11, Annex 11 and other regulatory requirements.
• Oversees qualification of instruments, equipment, facility, clean rooms and computer hardware - software.
• Maintain, enforce and improve Food Safety Program/ HACCP/ FSSC 22000 certification.
• Performs internal audits, self-inspections in areas including quality control, manufacturing, warehousing, packaging, food safety. Ensures observations are corrected.
• Review and approve Change Control records acting as a subject matter expert, ensuring compliance with internal policies, procedures, and guidelines.
• Perform and conduct risk assessments for various GMP topics.
• Administrator of Quality Management Software

Benefits

• Contract-to-hire position
• Competitive pay rate of $65,000 - $75,000
• 1st shift schedule (8a-5p) M-F

What This Job Offers

• Career Level: Mid Level
• Industry: Professional, Scientific, and Technical Services
• Education Level: Bachelor's degree