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The External Product Quality Specialist will be Responsible for providing Quality support to the external and third-party product portfolio of generic and branded products, inclusive of products in development through product discontinuation.
- Perform Quality Assurance activities associated with new external product development, Innovative Lifecycle Management, or commercial projects, ensuring accuracy and integrity of all data submitted to applicable regulatory bodies.
- For contractor manufactured drug products, combination products, and/or medical devices, serves as the Quality liaison between vendors, private label customers maintaining effective communication systems for quality expectations and compliance.
- Provide Quality guidance and expertise to manage product changes and issue resolution.
- Provide support to the Research & Development and Operations groups to promote continuity of product lifecycle management.
- Review and/or approve product related documents including, but not limited to, material specifications, finished product specifications, master batch records, change control documents, investigations, deviations, regulatory submissions, stability protocols, process validations or verifications, design history file, device master record, and device history record.
- Contributes to the compilation, review, approval, and reporting of Annual Product Reports.
- Performs quality audits of batch records to support finished product release for designated product during new product development.
- Represents company interests through review of contractor records for release of purchased product.
- 4 years’ experience (Bachelor’s degree) required in a GMP-related industry (Pharmaceutical, Combination Product, and/or Medical Device).
- Minimum of 2 years of experience in Quality Assurance or Analytical Services/Quality Control.
- Certifications / Licenses ASQ certification a plus.
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Posted: Apr 30, 2020
Type: Full Time