Job Description

Target Pay Rate: $25-30/hr **salary will be commensurate with experience Duties:
•    Observes and performs critical processing steps and provides real-time feedback.
•    Redlines and reviews process Standard Operating Procedures (SOPs).
•    Develop a suitable level understanding of the company
GMP manufacturing process(es) and be able to skillfully execute and troubleshoot them. 
•    Performs inventory control and cycle counts. Resolves and reports issues with product accountability and inventory system discrepancies.
•    Executes real-time batch record review. Performs alarm monitoring and reconciliation.
•    Reviews and completes documentation to support production activities, including batch record events and management of forms and labels on the production floor.
•    Collaborates with stakeholders and customers to resolve production-related issues. 
•    Conforms to established safety procedures in accordance with OSHA and other regulatory agencies.
•    Serves on safety, quality, and other committees, if applicable.
•    Attends and actively participates in waste walkthroughs, 5S, kaizen events, lean six-sigma, quality, safety or environmental training/initiatives, as required.
Skills:

• Build strong, open, and collaborative working relationships with both internal and external stakeholders.
• Strong attention to detail.
• Ability to work safely and conscientiously in a manufacturing environment.
• Leads tasks to completion.
• Experience in aseptic operations preferred.
• Background in cell/tissue culture, BSCs, isolators, aseptic gowning and qualification, and ISO 7/8 cleanroom operations is strongly desired
• Experience with batch record execution, including good documentation practices preferred
• Must be able to work in a controlled or clean room environment requiring special gowning including a face mask.
• Individuals may be required to sit, stand, walk regularly, and occasionally lift 20-25 pounds.

• A minimum of 0+ years of experience in a cGMP manufacturing environment along with a degree in science or a technical related discipline OR a minimum of 1+ years of cGMP manufacturing experience with a high school diploma is required.

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