Safety: ● Participates in monthly safety meetings.
● Reports all safety issues, concerns, incidents and near misses to the team leadership.
● Works with the safety and leadership team to provide input for potential safety issues as well as contributing ideas, implement all safety initiatives by actively and effectively communicating the initiatives and by helping others to understand the initiatives.
● Works with the safety team to ensure that the resources required addressing safety issues are secured in a timely manner and that the effective resolutions are put into place and trained
Quality: ● FDA audit understanding and awareness.
● Ensures process in areas is following proper procedures at all times.
● Follows effective procedures to ensure the production of a safe and efficacious product. Adhere to all SOPs and cGMP's.
● Identifies areas of deficiency to the management team and offers potential suggestions for improvements.
● Participates in both deviation investigations when appropriate and implementation plans to ensure a quality product.
● Works with the management team to complete deviation investigations and root cause analysis.
● Writes edits and reviews process documentation for completeness and Understands the function of the quality group.
Delivery: ● Performs production in accordance with volume fluctuation, business need, and effective cGMP procedures.
● Ensures all materials required for production are available prior to use.
● Completes sampling and corresponding documentation as required.
● Ensures the completion of move tickets to ensure accurate inventory.
● Identifies all production issues and relays them to the management team.
● Works to prepare assigned areas for the oncoming shifts.
● Completes tasks and corresponding documentation as required by cGMP.
● Follow all procedures to ensure safety of self and others.
● Works to complete quality documentation (BPR's, logbooks, etc.) accurately in a timely manner.
Cost:● Participates in all aspects of inventory management (SAP, cycle counting, ordering, LIMS, Deviation Trackwise, eDOC etc.).
● Actively communicates improvement ideas, issues, concerns, etc. to team members along with providing solutions.
● Works to resolve common production issues related to area of work.
Involvement: ● Involved in at least one cross functional teams where necessary to complete projects in an effective and timely manner.
● Understands respect, professionalism and confidentiality.
● Completes at least 1 process training in new area whenever possible and Continues development by completing at least one developmental class annually.
● Works to become trained in all assigned training modules.
● Maintains qualified trainer status if applicable.
All other duties as assigned.
Broad Coursework in such as:
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