Quality Control Analyst II - Microbiology

Paragon Bioservices, Inc. (PBI) is a growing Biotech Contract Development and Manufacturing Organization (CDMO) with an internationally recognized tradition of quality and service. Paragon Bioservices provides
process development and GMP manufacturing services for Phase I/II clinical trials to industry leaders as well as innovative start-ups utilizing novel technologies to produce state-of-the-art vaccines and therapies for people when they are most in need. As a PBI employee, you will actively contribute to the delivery of our services and products to our customers and their patients.

The QC Analyst II, Microbiology is actively engaged across multiple departments as well as within a dynamic project team. The Microbiologist must display strong technical knowledge, initiative, and scientific commitment, while making significant scientific and technical contributions within the quality control, quality assurance, validation, and manufacturing groups.

Key Responsibilities include but are not limited to:

• Perform microbiological testing for buffers/solutions, in-process manufacturing samples, bulk drug substance and finished drug product samples.
• Develop and perform validation testing of microbiological methods for client specific products and materials
• Draft, review and revise microbiological procedures.
• Document writing, data interpretation, results presentation, statistical analyses, and trending
• Assist in developing a microbial contamination control plan and program, with a focus on sterility assurance and manufacturing drug products under controlled conditions
• Assist in the tracking, trending, and identification of all facility microorganisms including cataloging and generating stock of facilities resident microflora
• Evaluate manufacturing processes for potential to eliminate and limit bioburden (for example, HACCP or FEMA approach) as well as reviewing cleaning steps, equipment hold times, HVAC, control level of environments for critical tasks, open-system vs closed-system operations, and bioburden monitoring.
• Perform cleaning and disinfection validation studies as wells as minimization of cleaning material residual control
• Establish phase appropriate contamination control, gowning procedures, and operator training
• Assist in implementation of industry best practices for Environmental Monitoring and the monitoring of clean utilities in the facility
• Other duties as assigned

Experience & Education:

• Bachelor degree in a Life Science field required; Microbiology preferred
• 2 years of experience and knowledge in the pharmaceutical and/or biotech industry in sampling and testing of critical utilities and environmental monitoring within a GMP environment
• Extensive experience performing USP testing such as bioburden, growth promotion, endotoxin, TOC and conductivity
• Must be able to gown as required in Aseptic Manufacturing areas
• Strong aseptic technique experience
• Advanced knowledge of cGMPs, safety, proper documentation, and data integrity
• Knowledge and application of GMP principles, and working in an FDA regulated environment
• Strong communication skills: oral/written and listening

Paragon Bioservices is proud to be an Equal Employment Opportunity and Affirmative Action employer. We do not discriminate based upon race, religion, color, national origin, gender (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, gender expression, age, status as a protected veteran, status as an individual with a disability, or other applicable legally protected characteristics.

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