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Manufacturing Specialist II
PRINCIPLE DUTIES:
- Utilizes expert knowledge of compliance and GXP manufacturing processes to manage investigation and improvement initiatives within manufacturing operations.
- Participates in cross functional teams to drive investigation close outs, determine root cause and implement appropriate Corrective and Presentative Action.
- Utilizes manufacturing process knowledge and investigation skillsets to identify and resolve manufacturing issues, improve process operations and affect positive changes.
- Conducts document revisions and/or document management including batch production records, and manufacturing procedures.
Requirements:
- High school diploma/GED or Biotech Certification with 5-7 years of experience in cGXP manufacturing environment, or Bachelors degree with 3-5 years of experience.
- Technical Writing, Deviation Investigations, Corrective and Preventative Action, Planning Document Change Requests Change Control Execution
- Demonstrated knowledge/understanding of biologics manufacturing.
- Knowledge and demonstrated an understanding of GXP and how it applies to specific responsibilities and manufacturing operations.
Does your experience reflect what it takes to be successful in this role? Do the work and challenges get you excited about what's possible? Then please send your resume now for immediate consideration.
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