Supervisor, Environmental Monitoring

Indivior • Raleigh, NC

3d • Onsite

About The Position

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. Responsible for effectively hiring, developing, coaching, counseling, managing and motivating the EM staff. The number of direct reports fluctuates with the needs of the business. Responsible for the timely and accurate completion of required environmental samples and collection of water and other site utility samples. Assures compliance to cGMP and Indivior specifications. Identifies areas for validation and/or improvement and develops protocols for same. Inform Senior Manager of QC of departmental activities and product related events. This position may represent the QC department at meetings and provides guidance in the absence of the Senior Manager of QC.

Requirements

• Bachelor’s degree in microbiology, biological sciences or related field required
• Requires three to five years of progressive laboratory/environmental monitoring responsibility in support of pharmaceutical manufacturing or equivalent related industrial or clinical experience
• 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

Nice To Haves

• Experience in aseptic processing is preferred
• Supervisory experience preferred, but candidate must have held some type of leadership role

Responsibilities

• Supervises daily activities of EM technicians.
• Assures that job activity deadlines are met on a timely basis.
• Ensures daily quality concerns and questions are being adequately addressed by department personnel.
• Ensures system for monitoring and trending environmental data is up to date and data is approved
• Assures 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
• Ensures all employees that enter the APA are gown qualified / requalified and participate in annual media fills
• Assess planned repair work to be performed in the classified areas and completes the QC Approval of CWOs for the work to be performed
• Ensures 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.
• Assures steps are being taken to maintain positive personnel morale and development.
• Conducts performance evaluations
• Assures execution of monitoring and testing programs to assess the microbiology quality parameters of in-process, environmental systems and effectiveness of production processes
• Establishes goals for the timely release of product and performance of projects.
• Monitors performance of the group against the goals to identify and implement needed corrective action.
• Ensures that product or an environmental system not meeting specifications and limits is promptly investigated
• Identifies possible source and corrective action needed and evaluates the impact upon the lot
• Identifies significant adverse quality trends by preparing and analyzing summary reports
• Addresses quality control test results, microbial profiles of environmental systems.
• Generates and updates Standard Operating Procedures
• Maintains current knowledge of cGMPs and regulatory issues/guidelines
• Assures department is equipped with functional, calibrated equipment and necessary supplies
• Supervises investigations of out of specification results and environmental excursions
• Ensures adequate evaluation of new product processes
• Represents the department in cross functional teams and meetings
• Performs other duties and projects as assigned by management

Benefits

• 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

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level