Description: QA Specialist - specifically supporting implementation of a new batch record system This position is responsible for all QA activities that directly support execution of the process both within the Process Execution Team (PET) and in assigned areas outside of the PETs. These activities may include, but are not limited to, batch release, change control and documentation, equipment and process validation, deviation investigations, SOPs, supplier management, distribution center management, and regulatory interactions.
Major Responsibilities: Maintains a high level of understanding of relevant production processes and quality systems Performs the QA review and approval of the following GMP documentation that has direct impact on the activities performed by, and facilities utilized in their corresponding areas as applicable: • Change Requests • Batch Records and associated documentation • Product and Component Release transactions in SAP • Quality Investigations (Deviations, Product Complaints) • Validation Plans, Protocols and Reports • Standard Operating Procedures
Bachelor’s degree in a Science / technical field such as Pharmacy, Biology, Chemistry or Engineering Excellent oral and written communication skills Strong ability and motivation to learn
All your information will be kept confidential according to EEO guidelines.
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