The Environmental Monitoring Supervisor will be responsible for overseeing the daily operations of a group of analysts and sets clear expectations around the delivery of the EM and utility work load. The supervisor ensures that all activities within the laboratory are performed in compliance with cGMP and internal written procedures and policies. The supervisor is responsible for scheduling personnel and material resources to ensure that sampling/testing commitments are satisfied and communicate any difficulties to QC management. The supervisor is accountable for the accuracy, integrity, and security of all results generated by the working group. The supervisor measures progress, evaluates results, and takes responsibility for outcomes.
Major Responsibilities
Supervise laboratory investigations for EM and utilities. Train analysts in the investigation process. Write or review investigation reports as required by the investigation procedure.
Maintain aseptic gowning qualification and perform environmental monitoring for aseptic fill lines if reports are absent.
Attend meetings and give Microbiology input and direction to teams. Elevate batch impacting decisions to management.
Work with manufacturing to appropriately schedule direct reports work. Coordinate schedule with first shift and off shift supervision as well.
Ensure all assigned timelines are met including reviewing, deviations, projects, weekly assignments etc.
Ensure staff is adequately trained to perform job assignments. Execute training in accordance with written procedures and assist in the preparation of training programs and curricula.
Provides personnel to support the training of manufacturing personnel on MODA, water sampling, settle plates, RODAC, and air plates
Participates in personnel decisions (interviewing, hiring, performance appraisals, promotion, disciplinary action, staff development, coaching and counseling) regarding subordinate staff
Write, revise, or review SOP's, environmental and validation protocols, and controlled forms
Identify and report unsafe conditions within the laboratory
Actively participate and contribute to the Laboratories mission and objectives. Facilitate dialogue and value input from others
Deliver key business messages in a timely manner and support continuous improvement
Qualifications
Preferred Skills/ Abilities:
Supportive/Proactive approach to business demands
Strong technical knowledge of environmental monitoring and utilities testing (endotoxin, conductivity, bioburden, nitrates, TOC)
Thorough knowledge of aseptically filled sterile drugs. Additional knowledge of biologically derived products and non-sterile solid doses helpful.
Strong mentor for staff with ability to help others develop and maintain a great team.
Demonstrate diplomacy and tact to diffuse tense situations and presents arguments to support decision/ point of view
Excellent organizational, planning, and scheduling skills.
Ability to make decisions efficiently and correctly to align with GMP or SOP requirements.
Excellent verbal and written communication skills
Maintains a clean, organized lab environment
Ability to cope with a rapidly changing work environment
Motivates personnel to participate and grow within the department
Required Education/ Experience:
Bachelor's Degree in a Life Science (Microbiology preferred) or equivalent
8+years ofexperience in pharmaceutical manufacturing
Preferred Experience:
Prior supervisory experience (approx. 2 years) managing direct reports and performance reviews in an aseptic pharmaceutical setting
Alkermes, Inc. is an equal employment opportunity employer and does not discriminate against any applicant because of race, creed, color, age, national origin, ancestry, religion, gender, sexual orientation, gender expression and identity, disability, genetic information, veteran status, military status, application for military service or any other class protected by state or federal law. Alkermes also complies with all work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA. Alkermes is an E-Verify employer.
