Key Responsibilities
- Supports activities for releasing or rejecting raw materials, starting materials, intermediates, drug substance, and drug products.
- Reviews completed batch production and laboratory control records of critical process steps before disposition of drug product for clinical distribution.
- Reviews of Quality Control analysis and results to support product release.
- Performs quality inspection of raw materials, intermediates, packaging and labelling materials.
- Conducts Quality on the Floor activities including, but not limited to, quality walk-throughs, change-over, drug product AQL inspection, and line clearance. Assists on changes that potentially impact intermediate, drug substance, and/or drug product quality.
- Assists in the investigation and resolution of quality events.
- Participates in cross-functional collaborations to meet project timelines and material/product supply requirements
Position Requirements
- Previous experience with GMP in pharmaceuticals, medical device, cell therapy, or biologics.
- Robust understanding and knowledge of quality assurance concepts, investigations, and process improvements.
- Willingness and ability to be on-site 5 days of the week.
- Excellent communication skills, both written and verbal
- Strong organization skills and ability to effectively manage multiple priorities.
- Ability to set and achieve goals to develop professionally.
- Ability to work independently and solve problems creatively.
- Comfortable working in the fluid structure of a start-up biotech company.
- Integrity, confidence, passion and collaborative spirit are highly valued.
Preferred
- Experience working with on-site manufacturing.
- Experience with GMP manufacturing of cell therapy or biological products.
Education / Background
- Bachelors degree in Biology, Chemistry, Life Science.
- 3+ years of biopharmaceutical industry experience.
Work Environment / Physical Demands
This position requires the ability to occasionally lift and/or move up to 25 pounds. Specific vision abilities for this job include close vision, depth perception, and ability to adjust focus. Able to fully gown into GMP cleanroom suites that include Grade B to provide on the floor QA support for manufacturing activities. The common requirements of an office environment (e.g., computer screens, workstations, etc.) apply when not working in or around the laboratory environment. Car and airplane travel might be required of this role.
