Laboratory Manager

Description

1. JOB SUMMARY

• The Laboratory Manager will oversee and manage the operations of the Micro and Industrial Chemistry critical laboratories within the FDA registered facility of OTC (Over- the – counter) cosmetic products. This position is responsible for ensuring that both laboratories operate in compliance to GMP, FDA CFR 210 and 211 and to USP 61 & 62 guidelines, as well as overseeing bulk and raw material testing, batch records and the development of preventative measures to ensure the successful and efficient production of high-quality OTC cosmetic products.

1. RESPONSIBILITIES

• Manage daily operations of the Microbiology and Industrial Chemistry Laboratories, ensuring the timely execution of testing and analysis.
• Develop and maintain Standard Operating Procedures, Work Instructions and Standard Testing Methods for laboratory operations, ensuring they are up to date, in practice and compliant with FDA requirements including USP 61 and USP 62.
• Lead and mentor staff, providing training, guidance and professional development opportunities to microbiological staff and IC team.
• Maintain and implement Good Laboratory Practices, Good Manufacturing Practices and 5S for both laboratories to comply with FDA, USP and GMP regulations.
• Participate and lead internal and external audits, addressing any findings and ensuring corrective actions are implemented accordingly.
• Work closely with R&D and Manufacturing teams in reviewing first productions and address any ongoing production issues to ensure proper CAPAs have been implemented.
• Lead the investigation of any discrepancies in batch records, working with manufacturing and R&D teams to assess potential causes and implement corrective actions to improve process and right product outcome.
• Oversee microbiological testing for OTC and cosmetics and ensure compliance with USP 61 and USP 62 standards.
• Oversee testing and analysis of bulk and raw materials used in OTC and cosmetic formulas, ensuring compliance with defined specifications including review of batch records to assess and verify formulas, and that the raw materials testing meet established specifications.
• Investigate and report any deviations or out of specification results, ensuring timely resolution and documentation.
• Lead process change and improvements for the QC area as outlined in FDA & Customer audits.
• Monitor and review all lab equipment maintenance and calibration activities, ensuring compliance at all times.
• All other activities as requested by Quality Director.

Qualifications

EDUCATION

• Bachelor’s degree in microbiology, Biology, Chemistry, Biochemistry or a related field.

WORK EXPERIENCE

• Minimum of 3 years of experience in a laboratory management role within an FDA-regulated facility, preferably in the cosmetic or pharmaceutical industry.
• Strong knowledge of USP 61, USP 62, and other relevant regulations for microbiological testing.
• Extensive experience in Industrial Chemistry (IC) with a focus on batch record review, raw material testing, and formula adjustment.
• Demonstrated experience in managing laboratory operations, including equipment validation, method development, and personnel management.
• Proven ability to troubleshoot production issues, implement preventative measures, and lead continuous improvement efforts in laboratory and manufacturing environments.

Salary : $80,000 - $90,000