PharMEDium Services, LLC, an AmerisourceBergen Company, is a growing outsource compounding organization servicing hospitals nationwide.
The Project manager will p
articipate in and manage both stability and sterility activities in the stability program for PharMEDium's services. RESPONSIBILITIES:
- Assist in the design and acceptance of test method validation protocols, preparation and execution of stability testing protocols.
- Manage new product evaluations based on current stability data.
- Manage the development of compounding processes and standard operating procedures, project tracking, with outcome of adding new services to current offering.
- Manage container closure testing and sterility testing of new services.
- Support ongoing sterility and chemical testing of current services.
- Interact with PharMEDium's Management level personnel, which include Sales and Marketing, Legal, Quality Management, etc.
- Interact with outside vendors, and customers.
- Manage job related activities with contract laboratories. Review all data and reports for acceptance. Evaluate alternate contract laboratories; including performing audits as needed, for utilization and comparison against current contract laboratories.
- Manage activities related to End Preparation Assurance Program which include method transfers, method validations and daily review of results.
- Participate in all internal and external audits
- Manage complaint sample reporting and investigations
- Other duties as assigned.
- BS in Chemistry, Biochemistry, Biology, Pharmacy, or related science field.
- Five years related experience in Manufacturing, Quality, or Testing in a laboratory setting.
- Knowledge of various biological and chemical equipment testing modalities.
- Knowledge of sterility tests per USP Endotoxin testing per USP
- Experience in an FDA regulated industry.
- Ability to work well within a team and with minimal guidance.
- Demonstrated strength in problem solving skills.
- Strong written and verbal communication skills.