Environmental Monitoring (EM) Lead
The basic function of the Environmental Monitoring Lead is to conduct environmental monitoring activities according to FDA, cGMP and Boston Analytical, Inc. Standard Operating Procedures. In addition, the lead mentors and trains the Microbiologists in their team. The essential duties and responsibilities of this position include the following. Other duties may be assigned as needed.
PRIMARY DUTIES AND RESPONSIBILITIES
- Acts as lead trainer and mentor to microbiologists on their team.
- Leads teams at client sites to ensure consistency and quality in the work that is produced.
- Acts as point of contact for client’s questions and concerns, with the goal of client satisfaction, while the EM team is off site sampling.
- Responsible for the scheduling and prioritizing incoming work projects for the environmental monitoring team to meet client requirements as related to quality, on-time performance and TAT (Turnaround Time).
- Leads and helps develop environmental monitoring qualifications studies as well as new routine EM programs.
- Coordinates and communicates delays and technical issues with management in a timely manner.
- Acts as a point of contact and subject matter expert for job specific questions from team members.
- Performs and leads the peer review process in support of client and laboratory quality objectives.
- Devises and develops process and method changes for the solution of technical problems in collaboration with microbiology management.
- Schedules/coordinates, performs and reviews lab investigations and deviations with microbiologists in their group. Conducts root cause analysis and helps to implement solutions in collaboration with the microbiologists and management.
- Confers with Quality Assurance and Lab Management to design and/or improve standard operating procedures and/or training programs.
- Ensures all work performed is performed in compliance with Standard Operating Procedures, Good Manufacturing Practices, Regulations of the Food and Drug Administration, Company, Client and Pharmacopeial Methodologies.
- Collects Environmental Monitoring Samples onsite and offsite at client manufacturing sites.
- Analyzes and enumerates environmental monitoring samples.
- Performs routine data generation and problem solving with little to no rework.
- Performs system maintenance and calibrations to ensure equipment is operating with specified requirements.
- Follows all safety rules and regulations.
- Follows all cGMP rules and regulations.
- Documents work in a clear and organized manner.
- Maintain a clean and orderly laboratory environment.
- Proper handling of hazardous waste in compliance with the Company and DES hazardous waste rules.
REQUIREMENTS & QUALIFICATIONS
Qualifications include a BA or BS degree in Microbiology or related science discipline with 2+ years of related experience is required. Knowledge of cGMP and related compliance regulations and guidances is required.
This position requires a self-starting, motivated person who possesses excellent interpersonal skills who 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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