Your Role:
This position will support the daily Quality Assurance activities related to GMP manufacturing for cell therapy products. This position will also support the implementation of quality systems in compliance with cGMPs and other Company policies.
Essential Duties and Responsibilities:
- Perform compliance review of batch production records for GMP manufactured clinical products including QC release testing, labeling, packaging, and supporting documentation.
- Perform final review of room, equipment, and facility records and associated support systems to release areas for cGMP operations.
- Perform review of documentation to determine release status. Approve material for release or nonconformance investigation.
- Support routine in-phase inspections during clinical product manufacturing including but not limited to line clearances, product inspections, and packaging operations.
- Support receipt, inspection and release of raw materials and components.
- Assist with deviation investigations and resolution of minor discrepancies relating to manufactured products and raw materials.
- Review equipment documentation such as activity logs, chart recorders, calibration records, IQ/OQ/PQ, etc.
- Support the implementation and maintenance of QA databases and other electronic systems.
Requirements:
- Bachelor's Degree; A minimum of two years of related experience and/or training;
- Previous and substantial GMP experience is required, as is prior knowledge of word processing, database management, and record-keeping.
Mental Demands:
- Ability to organize/coordinate
- Problem Solve
- Perform with frequent interruptions
- Comprehend and follow instructions
- Make decisions using sound judgment
Physical Demands:
- Good eye/hand coordination
- Use keyboard/computer/phone
- Repetitive movement activities
Work Environment:
- Regular and predictable attendance
- Work Onsite. Sunday - Thursday, 08:00am to 05:00pm, however, flexibility is expected to meet evolving business and department needs.
- Work in restricted access to laboratory area
The hiring range for this position is expected to fall between $98,354 - $115,710/year, reflecting the range candidates can reasonably expect to be considered for at time of offer, based on factors such as experience, internal equity, and qualifications.
The salary of the finalist(s) selected for this role will be set based on a variety of considerations, including but not limited to internal equity, experience, education, specialization, skills, abilities, and training. The above range represents the Company's good faith and reasonable estimate of possible compensation at the time of posting.
In addition to your salary, the Company offers a comprehensive benefits package, including health, vision, and dental insurance, as well as a 401(k) plan. All benefits are subject to eligibility requirements. Certain positions may also be eligible for additional compensation such as bonuses or commissions.
