Website ICONMA, LLC
ICONMA, LLC
Company : ICONMA, LLC
Our Client, a Clinical-Stage Cell Therapy company, is looking for a Senior Associate, Quality Assurance for their Bothell, WA location.
Responsibilities:
- Execute the Day-to-Day Quality Assurance Tasks to Support Ongoing Manufacturing:
- Review and approve executed electronic batch record comments and resolve discrepancies with manufacturing personnel.
- Review and approve executed test results, perform review tasks in the laboratory information management system to issue Certificates of Analysis (COAs) as applicable.
- Provide quality support for manufacturing operations in the cleanroom.
- Be a quality point of contact for process support escalations, troubleshooting, triage and resolution.
- Perform routine hands-on QA activities such as intake of incoming patient apheresis and drug product pack-out activities.
- Compile, review and approve lot disposition records.
- Perform routine raw material disposition and approve raw material specifications.
- Perform review and approval of Deviation, Chage Control, CAPA, Excursion and Nonconformance record deliverables (as applicable).
- Promote a culture of safety and GMP compliance.
- Identify opportunities for continuous improvement.
- Provide support to complex change controls (as applicable).
- Support Process and/or Method Qualification and Validation activities by providing quality review of associated protocols, data and reports.
- Perform internal audits (as applicable).
- Support operational excellence initiatives.
Requirements:
- Experience in clinical and cGMP manufacturing required.
- Experience with electronic quality management systems (e.g. deviations, CAPAs, change management) required.
- Ability to work effectively both independently and with a team to set goals, develop sound project plans, monitor progress, and report results.
- Excellent communication, emotional intelligence and interpersonal skills.
- Motivated and organized critical thinker with solid cross-collaboration and business communication skills.
- Fast learner, adaptable, with creative problem-solving skills.
- Ability to work efficiently, prioritize workflow, meet deadlines and balance competing
- The desire and ability to work in a fast-paced, start-up environment.
- Excellent analytical skills and scientific/technical expertise.
- BS degree with 7+ years experience in a relevant field (e.g. biochemistry, chemical engineering, bioengineering, or related scientific field)
- 4-6+ years of experience in GMP biopharmaceutical operations with a minimum of 2+ years in GMP quality
- Proficiency using multiple digital GMP platforms
- Familiarity with Cellular Therapy manufacturing
- Familiarity with Lentiviral Vector manufacturing
Why Should You Apply?
- Health Benefits
- Referral Program
- Excellent growth and advancement opportunities
As an equal opportunity employer, ICONMA provides an employment environment that supports and encourages the abilities of all persons without regard to race, color, religion, gender, sexual orientation, gender identity or express, ethnicity, national origin, age, disability status, political affiliation, genetics, marital status, protected veteran status, or any other characteristic protected by federal, state, or local laws.