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successfactors

Microbiology Supervisor I

Perrigo
The Bronx, USA
Mid
Onsite
Discovered 1 weeks ago

Full Job Posting

Experience

  • Required · Bachelor’s Degree in Biology, Microbiology or related discipline, with three or more years experience in a GMP laboratory environment and one or more years of previous supervisory experience. Consideration can be given to candidates without previous supervisory experience who meet all other qualifications and possess considerable laboratory knowledge in a pharmaceutical environment. · Responsible for implementing and monitoring cGMP requirements for all data generated by the QC laboratory, including data integrity and controls. · Responsible for day-to -day activities of micro lab including scheduling of work, data review and release, and safety requirements · Responsible as registered supervisor for microbiology lab in NYS board of pharmacy permit and maintains renewal · Supervise, coach, evaluate, and oversee training of Microbiologists responsible for the testing of raw material, products, water and environmental monitoring of manufacturing and packaging operations. · Ensure all lab activates comply with cGMP requirements, FDA regulations, approved procedures, and internal SOPs. · Provide Microbiology support to operations by addressing quality concerns, conducting risk assessments, and escalating issues when appropriate. · Perform micro risk assessment for new raw materials and formulations to justify and assign appropriate specifications · Author, revise, review, and approve SOPs, test methods. specifications and other controlled documents; develop new procedures and improve existing microbiology lab procedures as needed. · Author investigations involving OOS or atypical results, environmental monitoring excursions, and other quality events in which microbiological risk is present. · Design and implement appropriate CAPAs · Monitor compliance trends and identify opportunities for continuous improvement. · Act as microbiology SME during inspections, customer audits, and internal audits while maintaining inspection readiness and implementing remediation activities. · Track and trend lab performance and safety metrics and implement changes when necessary to maintain customer service Benefits We believe our people are our greatest asset. Alongside competitive compensation, we offer benefits tailored to supporting you and your family, as well as career development opportunities to ensure you feel valued and supported, both professionally and personally. Find out more about Total Rewards at Perrigo. We are proud to be included in the Forbes list of "America's Best Employers by State 2024". Find out more here Applicants please note: To apply to this position please click the APPLY button at the bottom of the application. (The SAVE button will only save your profile information but not submit an application for this open position.) All application materials, including resumes and CVs, must be submitted in English. Thank you. We are an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, status as a protected veteran, or other characteristics protected by law. #weareperrigo

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