Quality Control Microbiology Engineer III
1 month ago
- Documentation according to written Standard Operating Procedures in accordance to Current Good Manufacturing Practices (cGMP) and Good Documentation Practices (GDP).
- Coordinates microbiological testing data for batch release
- Participation in project/client meetings and communications, providing scientific and technical expertise
- Authoring/revising Standard Operating Procedures, Work Instructions, Forms, and Protocols
- Review of investigations and documentation of non-confirming events and environmental excursions.
- Apply expertise of compliance requirements to maintain an inspection-ready state.
- Participate and act as subject matter expert during audits/inspections
- Develop and train QC Microbiology Engineer II on relevant business processes
- Processing of purchase orders for outsourced testing and lab supplies
- Coordinates work orders
- Other duties as assigned
- BA/BS in a science or relevant field required or equivalent experience
- Minimum 5-7 years of experience with environmental monitoring or within the biopharmaceutical industry
- Minimum required training; GxP/GDP Training, Safety Training
- Proficient with computer software such as; Microsoft Office, MODA/LIMS; Microsoft Visio (preferred); Netsuite (preferred); Maximo Asset Management System (preferred)
- Proficient knowledge of ISO and EU standards
- Strong knowledge of quality systems and ability to interpret Quality standards for implementation and review.
- Strong written and oral communication skills
- Strong technical writing skills
- Technical training experience
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