Manufacturing Associate (Night Shift)
TALENT Software Services
Job Title
Shift is Sunday Tuesday 6:00 p.m. - 7:00 a.m., with alternating Saturdays
Job Description: Process Knowledge
Understanding of process theory and equipment operation. Ability to learn biopharmaceutical manufacturing processes, including mammalian cell culture, depth filtration, tangential flow filtration, column chromatography, centrifugation, protein purification, and formulation of bulk drug substance. Support initiatives for process optimization. Identify and elevate processing issues and support solutions. Gain experience with automation systems (LIMS, MES, PI, etc.)
Technical Documentation
Provide feedback and/or suggested changes to operational procedures. Assist in the incorporation of new technologies, practices, and standards into procedures. Capable of writing and reviewing process documents
Quality and Compliance
Understanding of cGMPs as related to Commercial Operations. Ability to utilize Quality systems (Deviations, CAPAs, Change Requests, Action/Alert Reports, etc.)
Business
Ability to participate in projects and contribute to outcomes. Capability to learn and support new business systems (Track-wise, ERP, etc.). Support trending of defined department metrics
Skills
Strong communication skillsverbal and written Ability to work in a team environment, which includes good conflict resolution and collaboration Displays good initiative to identify areas for improvement and implement solutions
Education
-Bachelor's degree in a science-related area or engineering -Associate's degree in a science-related area or a Biotech certificate with 2+ years of experience in a biotech manufacturing environment or other regulated industry
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