Analytical Laboratory Manager

Position Summary

The Analytical Laboratory Manager will be responsible for the successful analysis of raw materials, bulks, and finished goods to ensure that they meet the high quality standards set by management and customers.

This position will oversee the daily operation of the analytical laboratory to ensure samples are being tested and results reviewed/released in a timely manner while managing the QC Analysts involved in testing to ensure adherence to all applicable procedures, Good Lab Practices (GLP), and FDA regulations.

This position will be responsible for analytical laboratory investigations, root cause analysis and method development/transfer/validation. The Analytical Laboratory Manager is responsible for the maintenance and contracts of all analytical instruments including (but not limited to) HPLC, ICP-OES, ICP-MS, XRF, and UV-Vis, as well as the review of all documentation generated by the Analytical Laboratory.

Responsibilities and Essential Duties

• Ensure SOPs, Work Instructions, and Methods are followed to meet and exceed the Quality Standards set forth in Specifications and the requirements of 21 Code of Federal Regulations Parts 210 and 211.
• Ensure the laboratory can perform new customer methods and requirements.
• Work to bring third-party testing in-house.
• Act as the Subject Matter Expert (SME) for the laboratory.
• Train and update technicians and staff on industry standards and regulations.

Oversee laboratory personnel to ensure the performance of in-process and final inspections, measurements, and analysis of bulk batches, finished goods, incoming bulks and/or raw materials in compliance with cGMPs and all applicable regulations, standards, and client requirements. These tests must be performed accurately, safely, efficiently, and in a timely manner.

• Develop new analytical procedures using existing or new analytical equipment.
• Train/mentor more junior laboratory personnel on proper laboratory procedures and methods.
• Maintain all testing equipment correctly and within manufacturers’ expectations.
• Coordinate testing and sample submissions to third-party labs.
• Maintain proper labeling, handling, storage, use, and disposal of solutions, samples, and hazardous waste.
• Ensure that the team maintains the highest levels of safety to build an environment where the team’s well-being is a top priority.
• Verify that instruments such as balances and laboratory equipment are properly maintained and calibrated.
• Maintain detailed and accurate records of all testing results, comments, deviations, and control information in coordination with the Quality Management Team.
• Manage projects in collaboration with other departments to ensure that goals and expectations are met.
• Build technical expertise through continuous learning.
• Think independently while working in a team environment.
• Perform additional duties as assigned.

Technical Skills Required

• Proficiency with HPLC, ICP-OES, and/or ICP-MS is required.
• Critical thinking and problem-solving skills are essential for this position.
• Ability to perform basic mathematical calculations.
• High attention to detail.
• Great communication skills (oral and written).
• Knowledge of laboratory safety procedures and practices is required to ensure a safe working environment.
• Experience with Microsoft Office Suite (Excel, Word, Outlook).
• Experience with performing root cause analysis investigations is required.
• Knowledge of Good Lab Practices (GLP) and Good Documentation Practices (GDP).
• General knowledge of 21 CFR Parts 210 and 211.

Experience Required

• Minimum of BS/BA degree in Analysis or Bioanalysis required. Other science degrees can be considered in conjunction with applicable work experience.
• 6 years or more prior analytical work experience in Consumer Personal Goods, food, pharmaceutical, or manufacturing industry.
• Demonstrated knowledge of analytical testing, analysis, and quality systems.
• Experience in authorship of Nonconformance/Notice of Event (NOE) documentation.
• Previous laboratory or process auditing experience preferred.
• Experience in a supervisory role within a laboratory environment.
• Organized, self-directed and motivated. Team oriented and collaborative.

Physical Requirements

• Regularly sit, stand, and walk for extended periods of time.
• Ability to sit, balance, climb, stand, bend, squat, squeeze, kneel, turn, crouch, stoop repeatedly.
• Physically able to lift 50 pounds periodically.
• Frequent exposure to varying temperatures, loud noises, heavy machinery, fumes, airborne particles, moving mechanical parts, electrical current, chemicals, and vibrations.
• Prolonged use of computer screens.

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