Microbiology Supervisor I

Perrigouk; New York (NY); Presencial; USD 90 000 - 120 000; Tempo integral

Vantagens oferecidas por esta oferta de emprego

Competitive compensation

Career development

Flexible benefits

Resumo da oferta

Perrigo is seeking a Microbiology Lab Supervisor in New York to lead a team of microbiologists ensuring cGMP compliance and quality across topical, nasal spray, and suppository products. You will oversee daily lab activities, data integrity, and regulatory readiness while coordinating with Manufacturing, Packaging, Engineering, and Validation to drive continuous improvement and risk assessments.

The role requires a Bachelor’s degree in biology or microbiology, 3+ years in GMP labs, and at least

Qualificações

• Bachelor’s Degree in Biology or Microbiology with 3+ years in GMP labs and 1+ year supervisory experience.
• Experience implementing and monitoring cGMP for data generated by QC labs.
• Experience scheduling work, data review, and safety compliance.
• Registered supervisor for microbiology lab in NYS board of pharmacy permit and renewals.
• Supervise training of microbiologists for testing raw materials and products.
• Ensure lab activities comply with cGMP, FDA regulations, and SOPs.
• Provide microbiology support addressing quality concerns and risk assessments.
• Author and approve SOPs, test methods, and specifications; develop new procedures.

Responsabilidades

• Lead a team of Microbiologists for testing of raw materials, products, water and environmental monitoring.
• Ensure compliance with cGMP, FDA regulations, and internal SOPs.
• Coordinate CAPAs and continuous improvement initiatives.
• Serve as SME during inspections, audits, and regulatory reviews.
• Track and trend lab performance and safety metrics.
• Support operations with risk assessments and issue escalation.

Conhecimentos

GMP laboratory experience

Supervisory experience

Data integrity awareness

FDA regulations knowledge

Formação académica

Bachelor’s Degree in Biology or Microbiology

Descrição da oferta de emprego

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At Perrigo, we are driven by our mission to Makes Lives Better Through Trusted Health and Wellness Solutions, Accessible to All. We are proud to be a Top 10 player in the European Consumer Self-Care market and the largest U.S. store brand provider of over the counter and infant formula. Dedicated to providing The Best Self-Care for Everyone, we are the people behind the brands you trust. We are Opill®, Compeed®, Solpadeine®, NiQuitin®, and many more. We Are Perrigo. We are committed to enhancing the wellbeing of our colleagues and consumers alike. We pride ourselves on fostering an inclusive, collaborative culture where each person can experience a sense of belonging.

Join us on our One Perrigo journey as we evolve to win in self-care.

Description Overview

To ensure the Quality and Compliance of raw materials and products by overseeing daily Microbiology laboratory activities including testing and personnel for the support of Perrigo operations and manufacturing needs.

Scope of the Role

The Microbiology lab Supervisor is responsible for leading a team of Microbiologists that provides testing of topical, nasal spray and suppository pharmaceutical products. This role ensures compliance with current Good Manufacturing Practices (cGMP), FDA regulations, internal quality systems, and approved procedures. The Microbiology lab Supervisor serves as a key quality Subject Matter Expert for microbial risk assessments in project teams for Manufacturing, Packaging, Engineering, and Validation.

Schedule: First shift, Monday through Friday. Occasional weekend on-call support may be required.

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.

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

Nearest Major Market: Bronx
Nearest Secondary Market: New York City