Job Description:
The primary purpose of the Analyst I position is to Support Quality Control Microbiological testing of drug substances, raw materials and process intermediates in support of clinical development and commercial programs under cGMP and GLP guidelines, address excursions and conduct investigations.
Essential Job Responsibilities:
⦁ Attire gowning for Grade B/A manufacturing areas and collect EM samples for viable air, non-viable particulates, and surface viable samples.
⦁ Perform QC testing of samples for bioburden, microbial identification, growth promotion, and Endotoxin analysis.
⦁ Receive manufacturing samples for QC analysis, ship samples to the contract labs testing, review data for lot disposition.
⦁ Read and Review routine EM plates, lab testing data, logbooks, and documents for product release and trend reports.
⦁ Understand and follow aseptic behavior, good laboratory and manufacturing practices, and documentation.
⦁ Author/update laboratory procedures, protocols, and help in EM data trend reports.
⦁ Support cleanroom qualification, gowning qualification, aseptic process qualification, and personnel monitoring for manufacturing activities.
⦁ Initiate Incident reports for OOS results and work with the team to find a root cause and corrective actions.
⦁ Perform QC lab support activities like lab set up, housekeeping, instrumentation maintenance, and coordinate instrument calibration.
Required:
⦁ B.S. degree in Biology/ or other life science related degree with 0-3 years of relevant industry experience in a quality control role.
⦁ While working towards a completed B.S. degree, consideration will be given to associate degree in Biology or related life sciences with 2-5 years direct industry experience.
⦁ Excellent knowledge of Aseptic technique and common microbiological testing
⦁ Knowledge of relevant, compliance and guidance documents
⦁ Must be able to gown into cleanrooms in support of testing and manufacturing activities
⦁ Good documentation (ALCOA +) and data organization
⦁ Ability to work weekends is required; while most of the schedule will be during a standard work week, there will be regular weekend work.Interpersonal skills and ability to contribute to the success of a team
Preferred:
⦁ Proven history of working in a fast-paced team environment, time management, and meet deadlines.
⦁ Team player with the ability and willingness to support other colleagues in the Quality Control department.
⦁ This support may include future cross training with analytical assays as needed
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⦁ Models our Core Values: Bold, Caring, and Results-Driven - consistently exemplifies the culture we strive to create, operates with transparency, and earns trust.
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