Supervisor, Environmental Monitoring
Indivior
August 18, 2026
On-site
Raleigh, NC
Operations
Position Overview
- Supervise Environmental Monitoring (EM) technicians and ensure EM production coverage on all shifts.
- Hire, develop, coach, counsel, manage, and motivate EM staff; conduct performance evaluations.
- Ensure timely and accurate completion of required environmental samples and collection of water and other site utility samples.
- Ensure compliance to cGMP and Indivior specifications; identify validation/improvement opportunities and develop protocols.
- Inform the Senior Manager of QC of departmental activities and product-related events; represent QC at meetings when needed.
Responsibilities
- Supervise daily EM technician activities; meet job deadlines; address daily quality concerns.
- Maintain an up-to-date system for monitoring/trending environmental data and ensure data approval.
- Collect environmental and site utility samples properly and on time.
- Serve as EM representative during internal and regulatory audits.
- Create EM summary reports to support site and product filings.
- Instruct gowning classes (new employee gowning; Aseptic Process Area/APA gowning) and approve employees to begin APA qualification.
- Ensure APA gown-qualified/requalified status and annual media fill participation.
- Assess planned repair work in classified areas; complete QC Approval of CWOs.
- Ensure EM data review/approval is delivered to MQA to support weekly System Release.
- Execute monitoring/testing programs for microbiology quality parameters.
- Set goals for timely product release and project performance; monitor progress and implement corrective actions.
- Investigate out-of-specification results/limits excursions; identify sources, corrective actions, and lot impact.
- Identify adverse quality trends; address QC test results and microbial profiles.
- Generate/update SOPs; maintain knowledge of cGMP and regulatory guidance.
- Ensure calibrated, functional equipment and necessary supplies; supervise investigations of excursions.
- Ensure evaluation of new product processes; represent department in cross-functional teams.
What You’ll Bring
- Bachelor’s degree in microbiology, biological sciences, or related field (required).
- 3–5 years progressive laboratory/environmental monitoring experience supporting pharmaceutical manufacturing or equivalent industrial/clinical experience (required).
- Aseptic processing experience (preferred).
- Knowledge of QC testing methods, validation techniques, and microbiology concepts.
- Ability to scientifically interpret analytical data in pharmaceutical applications.
- Supervisory/leadership experience (preferred).
- Excellent verbal and written communication skills (essential).
Benefits (as stated)
- Starting salary: $88,000–$95,731 USD (based on qualifications/experience).
- Competitive PTO; company closure Dec 24–Jan 1.
- Bonus eligibility (company/individual performance).
- 401(k) with 75% match on first 6% contribution; profit-sharing contribution equal to 4% of eligible pay.
- Annual Equity for All program; U.S. Employee Stock Purchase Plan 15% discount.
- Medical, dental, vision, life, disability; HSA/FSA options; adoption assistance; tuition reimbursement; concierge/personal assistance; voluntary benefits; wellness programs.
Application instructions: None provided in the posting.
- Supervise Environmental Monitoring (EM) technicians and ensure EM production coverage on all shifts.
- Hire, develop, coach, counsel, manage, and motivate EM staff; conduct performance evaluations.
- Ensure timely and accurate completion of required environmental samples and collection of water and other site utility samples.
- Ensure compliance to cGMP and Indivior specifications; identify validation/improvement opportunities and develop protocols.
- Inform the Senior Manager of QC of departmental activities and product-related events; represent QC at meetings when needed.
Responsibilities
- Supervise daily EM technician activities; meet job deadlines; address daily quality concerns.
- Maintain an up-to-date system for monitoring/trending environmental data and ensure data approval.
- Collect environmental and site utility samples properly and on time.
- Serve as EM representative during internal and regulatory audits.
- Create EM summary reports to support site and product filings.
- Instruct gowning classes (new employee gowning; Aseptic Process Area/APA gowning) and approve employees to begin APA qualification.
- Ensure APA gown-qualified/requalified status and annual media fill participation.
- Assess planned repair work in classified areas; complete QC Approval of CWOs.
- Ensure EM data review/approval is delivered to MQA to support weekly System Release.
- Execute monitoring/testing programs for microbiology quality parameters.
- Set goals for timely product release and project performance; monitor progress and implement corrective actions.
- Investigate out-of-specification results/limits excursions; identify sources, corrective actions, and lot impact.
- Identify adverse quality trends; address QC test results and microbial profiles.
- Generate/update SOPs; maintain knowledge of cGMP and regulatory guidance.
- Ensure calibrated, functional equipment and necessary supplies; supervise investigations of excursions.
- Ensure evaluation of new product processes; represent department in cross-functional teams.
What You’ll Bring
- Bachelor’s degree in microbiology, biological sciences, or related field (required).
- 3–5 years progressive laboratory/environmental monitoring experience supporting pharmaceutical manufacturing or equivalent industrial/clinical experience (required).
- Aseptic processing experience (preferred).
- Knowledge of QC testing methods, validation techniques, and microbiology concepts.
- Ability to scientifically interpret analytical data in pharmaceutical applications.
- Supervisory/leadership experience (preferred).
- Excellent verbal and written communication skills (essential).
Benefits (as stated)
- Starting salary: $88,000–$95,731 USD (based on qualifications/experience).
- Competitive PTO; company closure Dec 24–Jan 1.
- Bonus eligibility (company/individual performance).
- 401(k) with 75% match on first 6% contribution; profit-sharing contribution equal to 4% of eligible pay.
- Annual Equity for All program; U.S. Employee Stock Purchase Plan 15% discount.
- Medical, dental, vision, life, disability; HSA/FSA options; adoption assistance; tuition reimbursement; concierge/personal assistance; voluntary benefits; wellness programs.
Application instructions: None provided in the posting.