Job Directory Gritstone Oncology Specialist/senior Specialist, Quality Assurance Batch Release
Gritstone Oncology

Specialist/senior Specialist, Quality Assurance Batch Release Gritstone Oncology
Pleasanton, CA

Gritstone Oncology is a cancer immunotherapy company developing next-generation personalized cancer therapeutics.

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About Gritstone Oncology

Job Description

The Specialist/Senior Specialist Quality Assurance Batch Release supports the drug product manufacturing process with the following responsibilities:

* Development/review/approval of MBRs including development of Electronic Batch Records
* QA Review and approval of Executed Batch Records
* Address any comments or corrections identified during the Batch Record review process with internal manufacturing or CMOs as necessary
* Support review and investigation of discrepancies associated with the product batches
* Participate in quality related investigations and provide input for corrective and preventive actions
* Confirm all deviations and investigation reports are closed prior release of the batch
* Compile the batch disposition packages
* Maintain a batch record review schedule to ensure on-time product dispositions
* Support development/review/approval of department SOPs as required

Minimum Education/Experience

* Bachelor's degree (or equivalent), preferably in scientific discipline or a health-related field and at least 2 to 4 years of experience reviewing Batch Documentation in the Pharmaceutical industry
* Working knowledge of FDA and EMA GMP regulation and ICH guidance documents.
* Experience in the manufacture of biopharmaceutical drug substance and drug products
* Experience in discrepancy investigation and change management is a plus

Other Qualifications

* Strong organizational skills and attention to detail
* Able to work effectively in a fast-paced, small start-up company environment
* Self-motivated, self-disciplined and able to function independently as well as part of a team
* Strategic agility, strong critical and logical thinking with ability to analyze problems
* Ability work with Electronic Quality Management Systems
* Strong ability to prioritize, multi-task, and work in an evolving environment
* Excellent presentation and written/verbal communication skills
* Excellent computer proficiency (MS Word, Excel, PowerPoint)

About Gritstone Oncology

Gritstone Oncology is a cancer immunotherapy company developing next-generation personalized cancer therapeutics.

Headquarters
Size
102 employees
Gritstone Oncology

5858 Horton St #210

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