QC Microbiology Analyst III Job in Exton 19341, Pennsylvania US
BPS Inc. is a leading process consulting and contract engineering company. For 15 years we have been engaged in providing engineering and process support services to client biotech and pharmaceutical companies. Services include design engineering, automation engineering, manufacturing/process support, GMP compliance and validation.
Opportunity:
BPS Inc. has been retained to help recruit a contract QC Microbiologist for Morphotek's Biologics Pilot Plant in Exton, PA, 19341. The positions are available immediately initially for 12 months.
Job Summary
Under minimal supervision, be responsible for assisting with the start-up, operation and qualification of the QC microbiology laboratory as well as the critical utilities and operations environment in support of the cGMP biopharmaceutical Pilot Plant Facility. Once the facility is operational, the individual will provide technical skills and testing support for preclinical and phase I and II clinical materials by scheduling and conducting general microbiological and/or chemical testing including assays such as bioburden, endotoxin, TOC, conductivity, viable and non-viable environmental monitoring and microbial identifications in compliance with all applicable procedures and regulations. The analyst will deliver compliant laboratory data in support of clinical material manufactured in the Morphotek Pilot Plant, and in accordance with appropriate regulatory, corporate and scientific guidelines. The individual will assist with the management of raw materials, data review and data management as well as lead the qualification of instruments and assay validations as appropriate. The individual will write and review SOPs on laboratory procedures, instrument operation and test methods. The individual will lead investigations, be responsible for documenting assay failures, OOS events, and in implementing associated laboratory CAPAs. The ability to function in a fast-paced, highly-technical environment, and communicate effectively is essential to success.
Education/Experience:
· BS in Microbiology, or other relevant scientific discipline.
· A minimum of 6-10 years working experience in a cGMP Quality Control department in an FDA-regulated industry.
· Strong working experience with microbiological testing such as membrane filtration and direct plating bioburden, TOC, conductivity, endotoxin testing using kinetic chromogenic systems, microbial identifications and environmental monitoring experience using viable and non-viable methods.
· Experience with LIMS preferred.
· Ability to speedily perform repetitive tasks while maintaining attention to detail.
· Strong working knowledge of cGMP/ICH/FDA/EMEA regulations and guidelines
· Ability to identify, investigate, and solve assay and equipment related problems.
· Working knowledge of MS Office applications.
· Ability to prioritize and successfully execute projects
· Excellent oral and written skills preferred.
· Team player who can excel in a “hands-on” entrepreneurial environment.
· Physical requirements: handling of laboratory equipment, chemicals and biological materials. Ability to stand, walk, use hands to handle or feel, see, and talk or hear is required. The employee must occasionally lift up to 20 pounds and push/pull up to 50 pounds.