Environmental Monitoring Team Lead
4 weeks ago
The Environmental Monitoring Team Lead is responsible for conducting environmental monitoring activities in accordance with FDA, cGMP, and Boston Analytical, Inc. Standard Operating Procedures. This role also involves mentoring and training microbiologists on their team.
Key Responsibilities- Lead trainer and mentor to microbiologists on their team.
- Lead teams at client sites to ensure consistency and quality in the work produced.
- Act as point of contact for client questions and concerns while the EM team is off-site sampling.
- Schedule and prioritize incoming work projects for the environmental monitoring team to meet client requirements.
- Develop environmental monitoring qualifications studies and new routine EM programs.
- Coordinate and communicate delays and technical issues with management in a timely manner.
- Act as a point of contact and subject matter expert for job-specific questions from team members.
- Perform and lead the peer review process in support of client and laboratory quality objectives.
- Develop process and method changes for the solution of technical problems in collaboration with microbiology management.
- Schedule and coordinate lab investigations and deviations with microbiologists in their group. Conduct root cause analysis and implement solutions in collaboration with the microbiologists and management.
- Confer with Quality Assurance and Lab Management to design and/or improve standard operating procedures and/or training programs.
- Ensure all work performed is in compliance with Standard Operating Procedures, Good Manufacturing Practices, Regulations of the Food and Drug Administration, Company, Client, and Pharmacopeial Methodologies.
- Collect environmental monitoring samples onsite and offsite at client manufacturing sites.
- Analyze and enumerate environmental monitoring samples.
- Perform routine data generation and problem-solving with little to no rework.
- Perform system maintenance and calibrations to ensure equipment is operating within specified requirements.
- Follow all safety rules and regulations.
- Follow all cGMP rules and regulations.
- Document work in a clear and organized manner.
- Maintain a clean and orderly laboratory environment.
- Properly handle hazardous waste in compliance with the Company and DES hazardous waste rules.
Qualifications include a BA or BS degree in Microbiology or a related science discipline with 2+ years of related experience. Knowledge of cGMP and related compliance regulations and guidances is required.
This position requires a self-starting, motivated person who possesses excellent interpersonal skills and is able to effectively interact with all departments within the company and with client personnel.
Minimum Skills Requirements- Demonstrated skills in laboratory techniques.
- Solid computer skills.
- Knowledge of safe laboratory practices, including the proper procedures in handling chemicals and samples.
- Must be a team player with integrity and concern for the quality of Company products, services, and staff members.
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