Job Opportunity: Specialist, Quality Assurance (QA) ,MD
Number of Openings: 55
**Position Summary:**
The Specialist, QA will play a vital role in providing Quality Assurance support for GMP manufacturing of master/working cell banks, biological bulk drug substances, and finished drug products intended for human use. This position involves on-the-floor oversight of manufacturing operations to ensure compliance with regulatory and industry standards while driving quality improvements.
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**Key Responsibilities:**
- **On-the-Floor Oversight:** Spend 75% of the day in manufacturing areas, monitoring operations and ensuring compliance with quality standards.
- **Documentation Review:** Conduct real-time reviews of batch records, cleaning logs, and other documentation during the manufacturing process.
- **Collaboration:** Work closely with Manufacturing and support teams to troubleshoot issues and facilitate smooth operations.
- **Visual Inspections:** Perform Acceptable Quality Limit (AQL) inspections of drug products.
- **Batch Document Review:** Review and approve documentation related to media and buffer preparation.
- **GMP Documentation:** Create or update Standard Operating Procedures (SOPs) and review Master Batch Records.
- **Deviations Management:** Compile and address deviations observed on the floor, ensuring timely resolution.
- **Audits:** Conduct audits of manufacturing and support areas to ensure adherence to internal procedures and Good Documentation Practices.
- **Decision Making:** Make sound quality decisions with limited oversight and initiate continuous improvement initiatives.
- **Training Engagement:** Participate in training activities and manage individual training plans.
- **Additional Duties:** Perform other assigned tasks as needed.
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**Position Requirements:**
- **Education:**
- A degree in Engineering or Biotech field with 0-2 years of experience in QA/QC/Manufacturing within biologics, biopharmaceuticals, or a regulated industry;
- **OR** a Bachelor’s degree in a Scientific, Engineering, or Biotech field with 2-4 years of experience in QA/QC/Manufacturing.
- **Knowledge and Skills:**
- Understanding of Good Manufacturing Practices (GMPs), 21 CFR Parts 210, 211, and 600s, ICH Guidelines, and EU GMPs.
- Familiarity with biological manufacturing processes, including cell banking, fermentation, purification, and fill/finish.
- Ability to apply scientific and regulatory principles to solve operational and quality-related challenges.
- Proficiency with electronic systems and software, including Microsoft products; experience with LIMS, Master Control, and Trackwise is a plus.
- Strong analytical, troubleshooting, and decision-making skills.
- Capacity to quickly learn new manufacturing processes and adapt to changing client needs.
- Ability to work both independently and collaboratively in a team environment, meeting deadlines in a fast-paced setting.
