employment type: full-time
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Job Label: Environmental Monitoring Manager
Boston Analytical is a premier cGMP compliant laboratory, FDA and DEA registered for pharmaceutical analytical testing. We provide the highest quality analytical testing services to Pharmaceutical, Biopharmaceutical, and Medical device companies worldwide. Since 1987, Boston Analytical has been and remains dedicated to customer satisfaction, and to the fast and accurate analysis of our clients' products.
Boston Analytical is a growing pharmaceutical contract lab providing quality Analytical and Microbiological testing services. We are known for our quality and believe our success is driven by our employees. We provide our employees with a state-of-the-art work environment, excellent benefits and opportunities for development.
The Environmental Monitoring Manager is responsible for the day to day and strategic functions of the EM department. The EM Manager is responsible for scheduling and prioritizing work to meet customer expectations, ensuring all work is performed in compliance with the quality, health and safety objectives of the company. Provide technical support to Microbiologists and Group Leaders. Responsible for all aspects of staff management including training, hiring, conducting feedback sessions, employee development, retention and engagement. The EM Manager has direct responsibility for improving production efficiency while meeting the financial and service goals of the laboratory.
The essential duties and responsibilities of this position include the following. Other duties may be assigned as needed.
PRIMARY DUTIES AND RESPONISIBITIES
Leads the development and implementation of process improvement initiatives that promote increased productivity for the EM group and client EM programs.
Coordinates work projects to appropriately prioritize laboratory workload to meet client requirements as related to quality, on-time performance and TAT (Turnaround Time).
Distributes work to Group Leaders to maximize productivity.
Maintains quality performance metrics, conducts routine metrics review and root cause analysis in collaboration with the Group Leader and Microbiologists.
Devises and develops processes and methods for the solution of technical problems.
Trains, mentors and supervises Group Leaders on an as needed basis.
Confers with Quality Assurance and Lab Management to design and/or improve standard operating procedures and/or training programs.
Responsible for scheduling work in support of maintaining all deadlines.
Ensures that laboratory supplies, consumables, standards are available to perform the analyses within the required project turnaround time.
Communicates project delays, quality and or technical issues to the Microbiology Director, and/or Client Services Team, as needed.
Reviews lab nonconformance (investigation and deviations) with Group Leaders and Microbiologists. Conducts root cause analysis and implements solutions in collaboration with the team.
Manages all aspects of department operations as related to operating costs.
Responsible for the interviewing and the hiring of employees.
Provides regular ongoing performance feedback while serving as a coach and mentor.
Responsible for developing and communicating goals to Group Leaders and associated microbiologists.
Ensures all work is performed in compliance with Standard Operating Procedures, Good Manufacturing Practices, Regulations of the Food and Drug Administration, Company, Client and Pharmacopeial Methodologies.
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 Master’s and/or Bachelor’s degree in Microbiology or a related discipline is required. Must have laboratory experience with a minimum of 5 years of related work experience. Knowledge of cGMPs and related compliance regulations and guidances required.
Must have experience with the various products and services the Company offers including stability studies, method development and validation, LIMS and ELN.
This position requires a self-starting, motivated person who possesses excellent interpersonal skills; who is able to assume a leadership role in the laboratory; and, who is able to effectively interact with all departments within the company and with client personnel.
MINIMUM SKILLS REQUIREMENT
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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Related Keywords: Environmental, Monitoring, Samples, cleanrooms, EM, Morrisville, Triangle, LIMS, ELN, cGMP, FDA, Microbiology, Manager, "Environmental Monitoring"