Quality Release Specialist
We are seeking a Quality Release Specialist to be responsible for timely and effective GMP review of batch record documentation and final release of product.
Job Duties:
Single point of contact for the Batch Record Review Process includes requesting and organizing batch records, creating reports, production terminating and approving records, issue resolution, batch record approvals and release of product.
Assist with customer complaint investigations, quality events, and compliance investigations.
Reviews all batch documentation for accuracy and completeness according to cGMPs to ensure proper release.
Adheres to internal/external guidelines, specifications and regulatory requirements while reviewing batch documentation.
Positively interacts with internal associates to quickly and effectively resolve issues.
Addresses deficiencies and ensures completion of all follow-up actions to maintain consistent resolutions to all batch review issues.
Skills Required:
Prior experience with batch record review is preferred.
Strong background and skills in communication and computer related systems.
Demonstrates cGMP knowledge.
Strong interpersonal, written, communication problem solving skills and follow-up actions.
Must be well organized, accurate and attentive to details, creative, flexible and work with minimal supervision.
Experience/Schooling or Degree Required:
Minimum of 2 years' experience in Manufacturing, a Quality function, within medical device and/or drug environment.
Experience interacting with internal/external auditors is a plus.
Experience with electronic document control systems is desirable.
Oracle applications knowledge preferred.
ultradent.comEstimated Salary: $20 to $28 per hour based on qualifications.
Job Duties:
Single point of contact for the Batch Record Review Process includes requesting and organizing batch records, creating reports, production terminating and approving records, issue resolution, batch record approvals and release of product.
Assist with customer complaint investigations, quality events, and compliance investigations.
Reviews all batch documentation for accuracy and completeness according to cGMPs to ensure proper release.
Adheres to internal/external guidelines, specifications and regulatory requirements while reviewing batch documentation.
Positively interacts with internal associates to quickly and effectively resolve issues.
Addresses deficiencies and ensures completion of all follow-up actions to maintain consistent resolutions to all batch review issues.
Skills Required:
Prior experience with batch record review is preferred.
Strong background and skills in communication and computer related systems.
Demonstrates cGMP knowledge.
Strong interpersonal, written, communication problem solving skills and follow-up actions.
Must be well organized, accurate and attentive to details, creative, flexible and work with minimal supervision.
Experience/Schooling or Degree Required:
Minimum of 2 years' experience in Manufacturing, a Quality function, within medical device and/or drug environment.
Experience interacting with internal/external auditors is a plus.
Experience with electronic document control systems is desirable.
Oracle applications knowledge preferred.
ultradent.comEstimated Salary: $20 to $28 per hour based on qualifications.
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