Planet Pharma ยท 1 day ago
Senior Associate, Quality Assurance
Bothell, WA
Full-time
Onsite
Senior Level
$35/hr - $48/hr
7+ years expPlanet Pharma is seeking a highly motivated and detail-oriented Quality Assurance Senior Associate to join their team at the Manufacturing Facility, LyFE in Bothell WA. This role involves performing routine Quality Assurance tasks and providing quality support for manufacturing operations, ensuring compliance with GMP standards.
BiotechnologyHealth CarePharmaceutical
Responsibilities
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, Change 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
Qualification
Required
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
Preferred
Familiarity with Cellular Therapy manufacturing
Familiarity with Lentiviral Vector manufacturing
Company
Planet Pharma
Planet Pharma is a pharmaceuticals company.
1001-5000 employees
H1B Sponsorship
Planet Pharma has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2022 (3)
2021 (5)
2020 (5)
Funding
Current Stage
Late StageLeadership Team
Cynthia Lewis
Senior Executive Recruiter, Life Sciences - PPG Advisory Partners
Emma Morris
President, PPG Advisory Partners
Company data provided by crunchbase