Quality Assurance Document Specialist

Job Title: Quality Assurance Document Specialist
Location: Berkeley, CA
Zip Code: 94710
Start Date: ASAP
Job Type: Contract
Keywords: #qualitycontroldocumentjobs #analyst

JOB RESPONSIBILITIES:
* Reviewing electronic batch records, interacting with QA staff and operations staff
* Identifying errors in the batch records and interacting with productions to ensure that the corrections are completed to support the QA release of API and drug substance batches

REQUIRED QUALIFICATIONS:
* Bachelor in Scientific field with 7 years of overall experience in the biopharmaceutical, biologics, medical device along with knowledge and understanding of cGMP concepts, and applicable US and foreign regulations
* 4 years of direct experience in Manufacturing and/or Quality in a GMP-regulated industry
* Ability to review API (active pharmaceutical ingredients) and Drug substance product to support on-time release of product.
* Experience reviewing and approving pharmaceutical manufacturing electronic and paper batch records and understand the review and approval process.
* Experience reviewing electronic batch records.
* Aware of the CFR cGMP regarding batch record review, familiarity with health authorities audit and how the Quality Assurance review impacts the release of a batch.

If you are interested in this role, please apply via the apply now link provided. Our overriding goal is to provide quality staffing solutions that help people, organizations, and communities succeed. Belcan is a leading provider of qualified personnel to many of the world's most respected enterprises. We offer excellent opportunities for contract, temporary, temp-to-hire, and direct assignments. We are the employer of choice for thousands worldwide. For more information, please visit our website at Belcan.com
EOE/F/M/Disability/Veterans