Job Description
One of our large pharmaceutical manufacturing clients is seeking a QC Microbiologist to join their Quality team in King of Prussia, PA. The Quality Control Microbiologist is responsible for overseeing all cGMP Microbiology testing including environmental monitoring for the King of Prussia plant. The incumbent will be a key member of the Quality team and will be responsible for the execution of microbiology testing of water, raw materials, and finished goods when specified. In addition, they will be responsible for trending microbiological data for the facility and performing out of specification data investigations. This position will work closely with the Director of Microbiology, Global Quality and other corporate functions for technical direction in this role.
Responsibilities include but are not limited to:
- Performs a variety of microbiological analyses on products, raw materials, water and in-process materials per quality system requirements.
- Interprets, evaluates, and reports the analyses in terms of accuracy and precision.
- Monitors and verifies quality in accordance with statistical process control, and conducts certification and training of employee's based on test methods and procedures.
- Applies method, instrument and data systems expertise to resolve problems.
- Links analytical and microbiological results with a basic understanding of manufacturing and packaging.
Required Skills & Experience
- Bachelor's degree in a science related field of study or extensive GMP experience (Preferred degrees in Microbiology, Biology, Molecular Biology, Chemistry, Biochemistry and Food Science).
- Minimum of five years experience in quality related processes
- Demonstrated use of advanced problem solving tools
- Industrial experience with Environmental Monitoring
- Strong analytical and problem-solving abilities.
Nice to Have Skills & Experience
- Advanced degree or certificate in quality related processes (e.g. Lean, Six Sigma) a plus
- Industrial experience with GMP testing of non-sterile drug product testing
- Experience starting up lab facilities supporting clinical and/or commercial manufacturing.
- Experience with regulatory agency inspections.
Benefit packages for this role will start on the 31st day of employment and include medical, dental, and vision insurance, as well as HSA, FSA, and DCFSA account options, and 401k retirement account access with employer matching. Employees in this role are also entitled to paid sick leave and/or other paid time off as provided by applicable law.