Title: MIR Scientist, 1st Shift
Responsible for managing the day-to-day manufacturing deviations (MIRs) Investigations within a section or functional area. Identify and assess quality risks in activities and processes related to manufacturing and follow West-Ward quality and current good manufacturing practices(c GMP). Participate and drive departmental Investigations to closure. Assist/drive and /or lead, Change Controls (CCRs), Customer Complaints and Annual Product Review (APRs).
- Ensure timely closure of in process and finished product investigations (MIRs).
- Write and Review Annual Product Reviews.
- Perform / Assist in Customer Complaints by collecting and analyzing objective evidence regardingrisks and corrective actions to remediate.
- Maintain a high level of Expertise in West-Ward’s Quality Systems and Current Good Manufacturing Practices in resolving technical issues.
- Participate in manufacturing projects in the role of contributor, coordinator or leader.
- Bachelor degree in the sciences or engineering. Strong Chemistry and/or Microbiology background preferred.
- 3-5 years experience in pharmaceutical processes or manufacturing.
- Exceptional organizational skills and ability to plan and implement resolutions to technical problems.
- Familiarity with current good manufacturing practices and quality systems related to asepticprocessing.
- Understand scientific strategies and be able to explore all avenues of investigation.
- Good interpersonal/ communication skills.
- Good project management skills.
- Working knowledge of FDA regulations with regards to Annual Product Review.
Cherry Hill, NJ, US, 08003
Nearest Major Market: Philadelphia