Quality Assurance Specialist II
Perform detailed/final review of manufacturing batch records for manufactured cell banks, clinical drug substance, drug product and final drug product, and large and small molecule finished goods for global IMP/Clinic/Market use.
As needed, provide Quality support and oversight of manufacturing activities for large molecule and small molecule.
Compile Batch History Records (BHRs) and batch release inputs for Product Manager review.
Assign batch record review and maintain batch release and scheduling database.
Support project management processes associated with lot disposition work and processes.
Scan and archive documents into a GMP document management system.
Create, revise controlled documents relating to Quality processes/procedures.
Identify, implement, and support process improvements, as appropriate.
Provide data and documents to support product quality impacting investigations; support investigation records as needed.
Troubleshoot and initiate the resolution of Quality issues by fostering effective and collaborative cross-functional partnerships.
Able to manage competing priorities with limited instructions.
Complete training required for the role.
Take on support work requested by Lot Disposition, Product Manager, QSPOC staff as needed.
Perform continuous GMP training.
May provide Quality support and oversight of manufacturing activities for large molecule, small molecule, and warehouse.
B.A. or B.S. degree (preferably in Life Science) plus 2-4 years of work experience.
A minimum of at least 2 years of experience in Quality Assurance, Quality Control, Manufacturing, or equivalent experience.
Thorough knowledge of cGMPs, and regulations applicable to U.S. and international Regulatory agencies.
Excellent verbal and technical written communication skills, excellent interpersonal skills, and negotiation skills are essential.
Must be able to apply cGMP concepts and requirements and use sound judgment and decision-making skills.
Familiarity with computer systems and ability to quickly become familiar with new software (e.g., EDMS, LIMS, SAP, CLARA, Veeva, Google software) is highly desirable.
Implement and maintain the Pharmaceutical Quality System (PQS) within the department.
Make independent decisions associated with daily activities and inform and consult management on complex issues. Resolve local issues with low to medium magnitude of impact.
Compensation range: $45 to $54/hr