RCA is a team of experienced professionals from FDA-regulated industries. Our team has navigated the front lines in Quality, Regulatory Affairs, Operations, Manufacturing and R&D. Not only does RCA understand the complexities of running a Life Science business, we can also negotiate the difficult demands of remediation and compliance with insight, hindsight and the clear advantage of our unique expertise and experience.
Job Title : Quality Specialist: Supporting Analytical Lab QC Testing/Mentoring
Job Code : 214
Position Overview :
- Support production/lab activities associated with the re-start of production on-site in India
- cGMP manufacturing plant support experience: API and/or Finished drug manufacturing (3 years minimum, target 3 – 5 years) (US/EU cGMP API manufacturing floor / lab bench experience preferred)
- Previous Warning Letter or Consent Decree remediation experience for manufacturing facility helpful.
- Willingness to work job rotations of 6 weeks on-site at the manufacturing production facility in India with two weeks “off” between rotations. Work minimum of 2 rotations for project.
- Work schedule is 6 days per week and one day off (depending upon shift/production schedule)
- Need to be able to climb stairs for several floors and stand for long periods of time while observing plant activities in real time.
- Need to be a team player within an international team of professionals and have a willingness to be flexible to the client’s changing manufacturing/laboratory priorities and schedules
Eligiblity : Four year degree in Microbiology, masters degree in technical discipline preferred
Added Skills Required :
- Experience/exposure of QC production sampling activities
- Bench top experience in analytical chemical testing of raw materials, excipients, API intermediates and/or API finished goods (3 - 5 years experience in QC sampling and testing in wet chemistry/analytical testing using chromatographic analysis/Microbiology)
- Strong Bench top experience at mentoring & qualifying chemists in the GMP aspects of analytical chemical testing of raw materials, excipients, API intermediates and/or API finished goods (significant experience in managing / mentoring QC sampling and testing in wet chemistry/analytical testing using chromatographic analysis/Microbiology)
- Good documentation practice: A portion of the time will be spent on executing checklists generated for production and laboratory cGMP processes and require legible hand writing and details of supporting back-up data for the checklist entries.
- Experience with Compendial testing a plus
- Strong working knowledge of cGMP Practices in FDA approved laboratory testing facility
- Significant experience in analytical method development/validation activities
- Practical understanding and experience resolving analytical testing deviations (OOT, OOS, etc.)/root cause investigations and effective CAPA’s
- Experience with mentoring / hands-on laboratory analyst in cGMP, GLP, GDP work
- Proven track record with mentoring / hands-on laboratory analyst in cGMP, GDP work
- Previous experience with analytical specification development is a plusThis project has 24/7 coverage expectation, work shifts can vary to support production needs
- Strong interpersonal skills required: communication, ability to multi-task and work in a team environment.
Apply Below :
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