A pharmaceutical Quality Assurance (QA) professional ensures that drug products are safe, effective, and compliant with regulatory standards. They proactively design systems to prevent defects throughout the manufacturing lifecycle. Daily duties encompass batch record reviews, handling deviations, and enforcing compliance with cGMP regulations.
Key Responsibilities
- Batch Release: Review and approve executed manufacturing, packaging, and testing records before final product disposition.
- Document Control: Author, review, and manage Standard Operating Procedures (SOPs), protocols, and master records.
- Deviations & CAPA: Investigate manufacturing issues (deviations) and manage Corrective and Preventive Action (CAPA) plans to resolve them.
- Change Control: Evaluate and approve changes to facilities, equipment, or processes to ensure ongoing compliance.
- Auditing: Conduct internal facility audits and support inspections by regulatory bodies like the FDA.
- Training: Develop and deliver training programs on cGMP and quality practices for site personnel.
Lab Manager
Qualifications & Requirements
- Education: A Bachelor's degree (B.S.) in Chemistry, Pharmacy, Biology, or a related scientific discipline.
- Experience: Typically ranges from 1–3 years for a specialist up to 8+ years for a QA Manager.
- Knowledge: Deep understanding of FDA, EMA, or other regional regulatory guidelines and Current Good Manufacturing Practices (cGMP).
- Skills: Strong attention to detail, technical writing, problem-solving, and cross-functional communication.
Company Description
Join a strong, stable but growing aerospace company that is going places. This is your opportunity to gain aerospace experience.
Excellent company benefits, including 401(k) with match. Chance for travel, both domestic and international and earned bonuses for exceptional work.
Come grow with us!