The basic purpose of this position is review and approvals of batch records, government release documentation and release of starting materials, in process and finished biological product. This position assures that all specifications are met prior to each stage of release to comply with USDA, FDA and cGMP regulatory requirements relating to these areas. The scope of support includes every stage of manufacturing, including product received from 3rd Party contract manufacturing organizations (CMOs). This individual will be a resource for related technical and compliance information within the Quality and Compliance unit.
Documentation Review/Approvals:
1) Prepares batch record documentation and performs review for compliance to Good Documentation Practices and against established SOPs/standards.
2) Resolves minor issues found during documentation review (documentation errors, missing information) as directed by SOP.
3) Resolves major issues that are not defined by SOP.
4) Reviews and approves Certificates of Analysis and Certificates of Conformance for batch release.
5) Performs review and approvals of APHIS Form 2008s against applicable Outlines of Production for submission to the USDA for all serial releases.
6) Reviews artwork proofs from vendors and prepares label specifications.Deviations/CAPA:
1) Writes or participates in deviation investigations for determination of appropriate root causes.
2) Performs follow-up on CAPAs for completion.
Training:
1) Completes all assigned training by target due dates as assigned.
2) Completes on the job training for each assigned job task.
3) Cross trains on other job tasks within department.
4) Assists with training other individuals within the department on specific tasks.
5) Performs training other individuals within department per assigned training plans.
6) Assists QA management with the development of training plans within department and trains others.
Regulatory:
Demonstrates understanding of regulations for various countries
This position requires ability to utilize computer programs such as Microsoft suite, SAP, IDEA for CON, Learning One Source and other relevant electronic applications.
Shift- First (8am 5pm)
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