Are you looking to join a company that has an outstanding history of developing and producing biodefense and lifesaving drugs and has signed deals with some of the largest drug development companies to manufacture the next COVID vaccine? A company where you feel a sense of ownership in your future? If so, look no further.
Our client is looking to hire a Manufacturing Analyst, Downstream
Job Summary:
The Manufacturing Analyst will ensure Downstream manufacturing deviations/CAPAs/CCs are timely addressed and closed relating to manufacturing ,technical operations, and quality control. Individual will be the SME for defending relevant deviations in GMP audits (internal and external) and will lead and coordinate efforts for continuous improvement in deviation reduction and manufacturing operations for the site.
Responsibilities include but are not limited to:
- Author and resolve Deviations, Change Controls, CAPAs and additional documents to support production needs and meet product release requirements
- Investigate deviations from all departments, perform thorough product impact analysis, utilize root cause analysis tools and work cross functionally to implement effective CAPAs
- Collaborate with area SMEs to write, review, revise and/or prepare manufacturing documents (BPRs, RPTs, SOPs, SWIs, etc.) in accordance with cGMPs and regulatory guidelines
- Independently analyze complex issues using risk appropriate decision making
- Initiate tracking and follow up of more complex issues stemming from deviation investigations
Experience & Skills:
- Bachelor’s Degree in Science and/or related field
- Minimum of 2-5 years experience writing technical deviations relating to manufacturing process and review documents
- Thorough understanding of the biopharmaceutical manufacturing process, current Good Manufacturing Practices (cGMPs), CAPA, CC and regulatory guidelines
- Working knowledge of root cause analysis tools and continuous improvement techniques