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Quality Assurance Specialist
Lyell is seeking a Quality Assurance, Specialist to support the Quality Assurance (QA) operations at the Lyell Manufacturing Center (LyFE) located in Bothell, WA. Scope of work includes, but is not limited to, drug substance and drug product lot disposition, batch record review, GMP cleanroom support, raw material management, and Quality System support including deviation, change control, and CAPA review and approval.
KEY ROLE AND RESPONSIBILITIES:
- Collaborate with key stakeholders and system owners on the continuous improvement of the Quality GMP processes at LyFE. Create and/or collaborate on corresponding SOPs.
- Represent Quality Assurance on project specific teams, as needed.
- Specialize in the Manufacturing Execution System (MES) processes, recipe approval, chain of identity controls,
- Perform QA approval of MES system validation work including system upgrades and recipe validation.
- Perform review and approval of executed electronic batch records, and resolution of discrepancies with manufacturing personnel.
- Perform review and approval of Change Management deliverables.
- Perform review and approval of Deviation and CAPA record deliverables.
- Provide quality support for manufacturing operations in the cleanroom facilities (e.g., changeover/line clearance support, APH receipt, product pack-out, event triage).
- Perform review of final product lot file and lot disposition.
- Participate in QRM activities (e.g., serve as Quality representative for risk assessments)
- Perform review and disposition of incoming raw materials, and approval of raw material specifications.
- Author and/or collaborate on the creation and revision of Standard Operating Procedures across the LyFE site.
- Support other routine Quality operations as required, commensurate with experience and the LyFE site maturation.
- A bachelor’s degree or equivalent in biology, biochemistry, chemical engineering, bioengineering, or related technological field or equivalent combination of education and experience, post-graduate coursework desirable.
- 6-8+ years of experience in GMP biopharmaceutical operations with a minimum of 4+ years in a GMP Quality role.
KNOWLEDGE, SKILLS AND ABILITIES:
- Experience in clinical manufacturing.
- Experience with quality management systems (e.g. deviations, CAPAs, change management).
- Fast learner, adaptable, with enterprise viewpoint and excellent cross-collaboration and inter-personal skills.
- The desire and ability to work in a fast-paced, start-up environment.
- Motivated and organized critical thinker with solid interpersonal and business communication skills.
- Demonstrated ability to work effectively with a team to set goals, develop sound project plans, monitor progress, and report results.
- Ability to work efficiently, prioritize workflow, meet deadlines and balance competing priorities.
- Excellent analytical skills and scientific/technical expertise.
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of the job. While performing their duties, the employee must be able to do the following:
- Confirm visual information in the environment such as; batch record and SOP steps were completed properly, parameters on equipment and computer screens, status of materials and equipment, and perform visual inspection of materials and product. A vision test may be required. Use of corrective lenses is acceptable.
- Stand and step over a gowning bench (12-24”) and aseptically don head-to-toe non-sterile and sterile gowns.
SHIFT WORK, WEEKEND WORK AND HOLIDAY COVERAGE:
Due to the nature of our autologous cell therapies and the need to deliver life-saving treatments to our patients as timely as possible, shift work, weekend work, and holiday work will be required.
We are looking for passionate team members to join our team that are willing to learn, grow, and evolve with us. Part of this evolution will be to work together to continually assess and modify our shift structure to best support delivering these critical products to our patients.
Lyell is proud to be an equal opportunity employer and does not discriminate on the basis of race, color, citizenship status, national origin, ancestry, sex, sexual orientation, age, religion, creed, physical or mental disability, medical condition, marital status, veteran status or any other characteristics protected under applicable federal, state and local laws.