Please note that this is a 1 year contract position.
High Quality background Manufacturing experience Experience with batch records Experience with filling/finishing vaccines/vials (or will look at candidates with filling syringes or the bulk stage experience)
• With Quality oversight, support the review and approval of equipment and process qualification/validation protocols and reports
• With Quality oversight, support the review and approval of process flow diagrams/product descriptions and subsequent master batch records - focus on large molecule cell expansion/bioreactor/purification manufacturing
• With quality oversight, support the investigation related to manufacturing deviations
• Review batch documentation provided by contract manufacturers (CMO) and responsible for product release in accordance to Company Supply Chain (JSC) procedures
• Ensure all required testing and documentation are provided and met release requirements. Including but not limited to:
• Review CMO Certificates of Conformance for batch release. Verify CMO certificates contain required information to confirm compliance of product to GMP, Company Specification and Quality Agreement requirements. Ensure all documents are in compliance with good documentation practice, data integrity, and accuracy of batch information, including but not limited to lot number, expiry date, within target ranges, etc..
• Ensure required Certificate of Analysis and Certificate of Conformance from bulk manufacturers and external laboratories are included and met specification.
• Ensure documentation review meets the requirements as specified for each product
• Generate Company certificate of release
• Maintain high level oversight of individual batch releases; able to give accurate, succinct updates on particular batch release status.
• Alert Supervision of any nonconforming results, out of trend, or out of specification results.
• Support supply chain logistics for on time shipment from CMO to Warehouse
• Complete and pass all applicable training required for access to the systems
• Complete and pass all applicable training for Good Manufacturing Practice and quality requirement training
· Bachelor Degree in a scientific function, or equivalent degree level, with minimum of 6+ yr healthcare industry experience
. Experience in quality function in Biologics or Vaccine industry preferred
. Previous experience in work environment under cGMP regulation highly desirable,
· Must have strong ability to maintain high efficiencies and accuracy in data entry.
. Strong proof reading skills to validate complex information and detect errors
. Strong quantitative and analytic abilities to analyze and validate data
. Ability to maintain and organized record file is essential
. Strong computer skills in Excel, Word, Sharepoint
. Ability to follow standard operating procedures and work instructions.
. Good interpersonal, communication and organization skills. Ability to manage multiple and changing priorities required.
· Detail oriented, dependable and motivated
· Willingness to initiative to alert supervision when encountering aberrant data.
Applicants must provide their phone number. Reference job number A390.