Analyst II, Quality Control Microbiology

Position Overview:

The incumbent will support the implementation and execution of core microbiology programs at Beam’s manufacturing facility in RTP, North Carolina. The NC manufacturing facility is a greenfield build and will be implemented in phases over a 6-8 Year period, with a focus on advanced therapeutic manufacturing technologies (cell and gene therapy modalities). The facility will start as a clinical phase manufacturing plant with the intent to move programs to commercial within the same facility. The incumbent will assist with the planning, implementation, and execution of microbiology workstreams in support of the facility startup plan. These workstreams and duties may include draft documentation for the microbiology programs, perform facility environmental monitoring (EM), conducting/drafting investigations, Gram staining, media growth promotion, endotoxin, bioburden and rapid sterility testing. The incumbent will work with colleagues in other Quality teams, as well as colleagues in manufacturing, engineering, validation to support the implementation of site contamination control goals and standards. The work schedule will provide support for site implementation activities and establishment of routine operations. Leveling for this position will be commensurate of experience.

Primary Responsibilities:

• Draft documentation for the microbiology programs (SOPs, WIs, Protocols, reports etc.)
• Conduct and draft investigations for the microbiology programs (EM excursions, lab deviations, product OOS’s, etc.)
• Support the implementation and execution of microbiology laboratory programs, including bioburden, endotoxin, and rapid sterility testing, method verifications, media growth promotion and gram staining.
• Support the implementation and execution of the environmental monitoring (EM) program.
• Review and approve laboratory data for the microbiology programs.
• Support the incoming testing and management of raw materials.
• Assist with the data analysis and trending program for EM data.
• Support the implementation of the disinfectant efficacy qualification program.
• Partner with CQV representative to support the implementation of QC lab equipment by providing technical assistance during the development and execution of IQ/OQ/PQ protocols.
• Provide assistance for the implementation of the site LIMS; support protocol execution when applicable.
• Additional duties as assigned.

Qualifications:

• Bachelor’s or Master’s degree in a scientific discipline.
• 2+ years’ relevant experience in the pharmaceutical/biotech industry.
• Excellent verbal and written communication skills.
• Strong writing skills.
• Strong team player that has a customer service approach and is solution oriented.
• Attention to detail and the ability to work equally well individually as within a multi-disciplinary team.
• Excellent time management skills.
• Consistent delivery of high-quality work at all times.