Supervisor, Environmental Monitoring

Job Title : Supervisor, Environmental Monitoring Location : Bedford, Ohio Job Type : Full-time Req ID : 11288 Job Overview This position is responsible for the supervision of microbiologists performing environmental monitoring procedures and for ensuring the accuracy of test results and raw data generated. The qualified candidate must possess a strong background in environmental monitoring of ISO 5/7/8 classified rooms, media fill trials, clean room qualifications, and air pattern analysis. Experience interacting with the FDA and other regulatory or audit groups is required. Responsibilities include resolving technical and equipment problems, implementing corrective and preventive actions, writing and revising standard operating procedures, forms, protocols, trending reports and change controls, and providing guidance to less senior staff. Key Responsibilities Control the workflow of the environmental monitoring staff by supervising, planning, organizing, and directing the activities of the group to support production, stability program, technical services, and R&D. Ensure adequate supplies and equipment are available for testing and maintain expenses at or below budget. Analyze workflow, prepare metrics, and make recommendations to improve productivity and efficiency of the group and generate cost savings. Enforce policies and procedures by monitoring testing techniques and accuracy of all records and documentation. Ensure team members are properly trained and proficient before allowing them to perform tasks. Review laboratory records for accuracy, completeness, compliance, and conformance to specifications. Approve laboratory records and initiate laboratory events and investigations as required. Ensure compliance and keep the department ready for both internal and external audits. Oversee instrument and equipment maintenance and calibration programs. Troubleshoot and resolve instrument and equipment problems. Conduct maintenance and calibrations in accordance with required schedules. Develop proposals for new laboratory systems and equipment. Execute qualification studies, prepare summary reports, and manage change controls. Stay current on laboratory instruments and methods. Ensure completion of all protocols, validations, and summary reports in a timely manner. Prepare and/or revise SOPs to ensure compliance with regulations and current practices. Keep current on regulations and industry best practices and update SOPs to improve compliance. Prepare and execute change controls as needed to support changes to the program. Make staffing recommendations, support laboratory cross‑training efforts, evaluate team member performance, conduct appraisals, and ensure team members have development plans. Resolve deviations by investigating and working closely with investigators to determine root causes. Prepare all necessary reports in a timely manner to meet compliance requirements and business needs. Interact with FDA and other regulatory/audit groups. Maintain working knowledge of FDA regulations and application of GLPs and GMPs. Qualifications BS with 5 to 7 years of pharmaceutical microbiology experience or an MS with 3 to 5 years of pharmaceutical microbiology experience. Minimum 3 to 5 years of supervisory experience. Excellent organizational and project‑management skills with the ability to handle multiple projects. Excellent writing and computer skills and ability to present data logically. Excellent interpersonal communication, influencing, and negotiation skills. Understanding of scientific strategies and ability to innovate new methods or research avenues. Demonstrated effectiveness in task completion, decision making, and problem solving. Working knowledge of FDA regulations, application of GLPs and GMPs, and experience interacting with personnel from regulatory agencies. Compensation Base Salary: $66,600 to $133,750 annually, determined during the interview process and varying based on location, experience, and other factors. Benefits Annual performance bonus, commission, and share potential Auto enrollment in a company‑sponsored 401(k) program with 3% pre‑tax contribution and company match of 100% of the first 6% contributed. Paid time off (PTO) starting with 20 days (prorated) and additional days granted at milestone anniversaries. Three personal days (prorated). 11 company paid holidays. Comprehensive benefits including health, dental, vision, mental health, disability, life insurance, prescription drug coverage, and voluntary benefits. Employee discount program Wellbeing rewards program Safety and quality are top priorities. Career advancement and growth opportunities Tuition reimbursement Paid maternity and parental leave Equal Opportunity Employer Hikma Pharmaceuticals USA Inc. is an Equal Opportunity Employer. Employment decisions are made without regard to race, color, religion, national or ethnic origin, sex, sexual orientation, gender identity or expression, age, disability, protected veteran status, or other characteristics protected by law. #J-18808-Ljbffr Hikma Pharmaceuticals