Published: April 29, 2021
- Plans and coordinates analysis of products, raw material, in-process samples, final bulk and final product samples, and water samples.
- Reviews the plant Environmental Monitoring program results and reports to management. Seeks that the appropriate corrective action is taken.
- Writes department reports to management concerning the environmental conditions of the manufacturing area.
- Gives technical guidance to laboratory technicians to efficiently solve situations related to the analytical nature of the tests.
- Proficiently utilizes all instruments and equipment in the microbiology laboratory. Has understanding of equipment's underlying principles of operation.
- Implements new instrumentation/technology into the laboratory operation.
- Maintains sample authorization flow to keeps the LIMS system updated for trend analysis.
- Develops, writes, implements, and audits the Basic Operation Procedures to ensure compliance with FDA CGMP's Corporate, and Divisional requirements.
- Performs QC lab audits. Maintains adequate materials and supplies inventory.
- Schedules the work, vacations, and holidays of laboratory technicians.
- Performs analytical effort required for special problem solving arising from production, R & D, Q.A., and facility/equipment validation studies. Maintaining excellent communication with Lab Coordinators to manage the lab priorities including the completion of the EM program, product release, and reinstatements, among others.
- Assures all QC lab. technicians complete training program for new or improved methodology.
- Participates in technical personnel selection, training, performance appraisal, placement, transferring discipline, and reprimands.
- Bachelor’s Degree in Science.
- 3+ years supervision experience in laboratory areas.
- Basic knowledge of governmental regulations and pharmaceutical compendia (USP, EP, BP, etc.)
- Excellent verbal and written communication skills in English and Spanish.
- Good statistical and scientific knowledge.
- These include laboratory troubleshooting and problem-solving skills.