- Direct QC testing of finished products requiring testing by cell culture, microbiological, PCR and simple automated chemistry methods. Assure compliance with site, divisional, corporate and regulatory guidelines, as applicable.
- Provide technical expertise to aid in making decisions on finished product release. In a timely manner, work with appropriate teams to make recommendations and/or formulate action plans for investigation and disposition of materials which do not meet release specifications.
- Serve as QC representative on cross-functional, inter-facility and product integration teams.
- Ensure lab throughput meets business demand by effectively planning resource and equipment capacity.
- Develop training and cross training plan of lab personnel to enable efficient lab throughput.
- Develop and maintain a flexible organization such that fast changing manufacturing priorities can be accommodated with a minimum of disruption. Work with manufacturing on a daily basis to meet their scheduling needs and avoid product backorders.
- Effectively manage, develop and motivate a team.
- Assure that all lab instruments and documentation are in compliance.
- Effectively lead projects as assigned. Plan, perform and evaluate experiments as needed.
- Implement practical process improvements to reduce lead times and improve turn-around times for lab testing. This includes lab metric development and countermeasures (e.g. daily releases, backlog >5 days, equipment down time, COA releases …)
- Perform other duties as assigned.
B.S. or M.S. Degree in Biology, Clinical Chemistry or related science with 10 years related experience of which five (5) must have been in a proven leadership role.
Non-Negotiable Hiring Criteria:
- Knowledge of the diverse operations of chemical Quality Assurance and Quality Control principles, statistic and computerization.
- In-depth knowledge of cell culture or microbiology testing and instrumentation.
- Ability to use critical judgment in a very demanding environment to address product or process problems under immediate time constraints.
- Ability to rapidly and effectively resolve testing and/or procedural problems.
- Ability to review current processes and implement productivity improvements.
- Demonstrated leadership and supervisor skills, including the ability to effectively motivate and develop employees and delegate work assignments.
- Strong “people skills” to be able to deal with various personalities and levels within the organization.
- Excellent verbal and written communication skills.
- Excellent organizational skills and be detail oriented.