Location: Buena, NJ
- Ensure compliance to GxP from the perspective of Quality Control (Microbiological Testing and Environmental Monitoring, Raw Material consumable, excipient, API testing and release. Ensure regulatory compliance through implementation of harmonized standards, testing, monitoring and reporting.
- Maintain the QC Microbiology Lab and function in full cGMP-compliance and continue to challenge the status quo of the labs to enhance throughput efficiency and Compliance while ensuring Method lifecycle management in these areas.
- Perform microbiological testing of compounded sterile products, Topicals and supervise scientists who perform the same.
- Maintain Environmental Monitoring Program to meet or exceed the requirements of USP, PCAB and other regulatory agencies.
- Responsible for installing laboratory equipment and qualify/validate lab equipment for intended use in QC Microbiology laboratory to support testing.
- Responsible for microbial testing method validation.
- Leads laboratory investigations and facilitates root cause analysis.
- Reviews documents to ensure completeness, accuracy, consistency, and clarity and ensures that materials or final products have been manufactured, tested, or inspected according to specification and cGMPs
- Collaborate with Manufacturing, Supply Chain and Logistics and Quality to ensure an uninterrupted supply of materials for use in Manufacturing.
- Participate in the preparation and consolidation of the budget of the Quality Unit.
- Identifies and implements improvement opportunities for established Quality Systems, processes, procedures, and training to support CAPA, Change Control, Deviation, Risk Management, and Investigation processes.
- Collaborates significantly with cross functional groups, including QC Analytical, QA, Validation, Manufacturing, Process Development, Facilities, and Regulatory Affairs.
- Minimum BS in Biology, Biochemistry or related discipline with at 5 + years supervisory /managerial experience. MS Biology, Biochemistry + 2 years in the alternative.