Supervisor, Environmental Monitoring

Position Overview

The Environmental Monitoring (EM) Supervisor is responsible for supervising the activities of Environmental Monitoring technicians and ensuring EM production coverage on all shifts is provided. They are also responsible for effectively hiring, developing, coaching, counseling, managing and motivating the EM staff.

How You’ll Make An Impact

• Supervises daily activities of EM technicians.
• Affirms that job activity deadlines are met on a timely basis.
• Affirms that daily quality concerns and questions are being adequately addressed by department personnel.
• Affirms that the system for monitoring and trending environmental data is up to date and data is approved.
• Affirms that proper and timely collection of environmental and site utility samples.
• Participates and serves as the EM representative during internal and regulatory audits.
• Creates EM summary reports to support site and product filings.
• Instructs the new employee gowning classes.
• Instructs the Aseptic Process Area (APA) gowning class and approves new employees to start APA qualification.
• Affirms that all employees that enter the APA are gown qualified / requalified and participate in annual media fills.
• Affirms that planned repair work to be performed in the classified areas is completed and QC Approval of CWOs for the work to be performed.
• Affirms that the review and approval of EM data is completed and delivered to MQA to support the weekly System Release process.
• Hires and oversees the training of department personnel.
• Affirms that steps are being taken to maintain positive personnel morale and development.
• Conducts performance evaluations.
• Affirms that execution of monitoring and testing programs to assess the microbiology quality parameters of in-process, environmental systems and effectiveness of production processes.
• Affirms that goals for the timely release of product and performance of projects are established.
• Affirms that performance of the group against the goals is monitored to identify and implement needed corrective action.
• Affirms that product or an environmental system not meeting specifications and limits is promptly investigated.
• Affirms that possible source and corrective action needed is identified and evaluated the impact upon the lot.
• Affirms that significant adverse quality trends are identified by preparing and analyzing summary reports.
• Affirms that addresses quality control test results, microbial profiles of environmental systems.
• Generates and updates Standard Operating Procedures.
• Affirms that maintains current knowledge of cGMPs and regulatory issues/guidelines.
• Affirms that department is equipped with functional, calibrated equipment and necessary supplies.
• Affirms that supervision of investigations of out of specification results and environmental excursions.
• Affirms that adequate evaluation of new product processes.
• Represents the department in cross functional teams and meetings.
• Performs other duties and projects as assigned by management.

What You’ll Bring

• Bachelor’s degree in microbiology, biological sciences or related field required.
• Three to five years of progressive laboratory/environmental monitoring responsibility in support of pharmaceutical manufacturing or equivalent related industrial or clinical experience.
• Experience in aseptic processing is preferred.
• Must be knowledgeable of quality control testing methods, validation techniques and concepts of microbiology.
• Must be able to understand and scientifically interpret data utilizing analytical skills and practical experience in pharmaceutical applications.
• Supervisory experience preferred, but candidate must have held some type of leadership role.
• Demonstrated leadership and supervisory skills.
• Excellent verbal and written communication skills are essential.

Physical Requirements

• Position is exposed to a number of environments, office, lab, outside, plant floor, etc.
• The role requires continuous computer use and typing, along with routine walking between offices, laboratories, and operational areas.
• Frequently talking and using eye and hand coordination.
• Occasionally requiring lifting and carrying less than 10 lbs.
• Standing, walking, bending over, and repetitive use of legs are done occasionally.
• Personnel engaged in the manufacture, processing, or holding of a drug product shall wear clean clothing appropriate for the duties they perform.
• Protective apparel, such as head, face, hand, and arm coverings, shall be worn as necessary to protect drug products from contamination.

How We Invest In Our People

• Starting Salary: $88,000-$95,731 USD
• Note actual salary is based on qualifications and experience.
• Benefits include:
• Competitive PTO plus company closure from December 24th- January 1st
• Eligible to participate in Indivior’s bonus program, based on company and individual performance
• 401(k) and Profit-Sharing Plan: Company match of 75% on your first 6% of contributions and profit-sharing contribution equal to 4% of your eligible pay
• Annual Equity for All program and U.S. Employee Stock Purchase Plan- 15% Discount
• Comprehensive Medical, Dental, Vision, Life and Disability coverage
• Health, Dependent Care and Limited Purpose Flex Spending and HSA options
• Adoption assistance
• Tuition reimbursement
• Concierge/personal assistance services
• Voluntary benefits including Legal, Pet Insurance and Critical Illness coverage
• Wellness programs as well as other discounts and perks