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
* 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
* 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.