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Partner Therapeutics, Inc.
Lynnwood, WA | Full Time
10 Months Ago
Quality Control Analyst (Onsite)
Full Time 10 Months Ago
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Partner Therapeutics, Inc. is Hiring a Quality Control Analyst (Onsite) Near Lynnwood, WA

QUALITY CONTROL ANALYST (Onsite)
The Quality Control Department is responsible for all testing related to the manufacturing and release of Leukine. These activities include testing raw materials, process intermediates, Drug Substance (DS), Drug Product (DP) and oversight of all contract laboratory testing. Additionally, QC supports microbiological control of the facility/utility systems and the manufacturing environment. This ensures Leukine product will consistently meet the pre-defined standards for patient safety and product quality.

KEY RESPONSIBILITIES

LABORATORY TESTING (~75%)

  • Perform release and stability testing according to SOPs for raw materials, in-process intermediates, BDS and DP
  • Peer review assay documentation to ensure completeness and good documentation practices
  • Troubleshoot method/equipment issues to find root cause and correct/prevent recurrences
  • Qualify critical reagents, materials, standards and controls to ensure suitable for intended use
  • Provide QC subject matter expertise on QC methods, equipment and software
  • Investigate and document deviation, determine root cause and product impact to propose corrective/preventive actions
  • Excellent verbal and written communication skills
  • Collaboration on writing SOPs, Laboratory Investigations, Change Controls, and Deviations
  • Train other staff on methods/techniques
  • Propose solutions to improve laboratory testing/method performance
  • Perform method qualification/validation activities to support the product or method lifecycle
  • May represent QC on internal/external teams
  • Ability to work with multiple cross-functional departments
  • Capable of working in an aseptic environment as needed
  • Perform other additional job-related duties, as required

COMPLIANCE (~25%)

  • Maintains an awareness, responsibility and accountability for cGMP and SOP requirements
  • Follows safety precautions in the laboratory
  • Maintains training requirements
  • Recognizes patterns/trends and proposes solutions to improve compliance

QUALIFICATIONS

  • Bachelor’s degree in Science related field (Ex. Microbiology, Biology, Chemistry, Biochemistry, Engineering) with a minimum of 5 years of relevant laboratory experience required; level depends on directly relevant experience
  • Proven experience in HPLC/CE preferred
  • Prior working experience in a regulated environment (GMP, GLP, etc.) is preferred

To ensure we are able to consistently provide Leukine to patients around the world and in support of our friends, families, and neighbors, Partner Therapeutics requires all current and future employees to be fully vaccinated against COVID-19. We require evidence of COVID-19 vaccination prior to hire, subject to reasonable accommodation and other requirements of applicable federal, state, and local law.

In addition to medical, dental, vision, FSA/DCA, HRA, disability, and life insurance coverage, all full-time, regular Partners enjoy a casual, and Hybrid or Remote workplace program for many roles. We offer a terrific compensation/benefits/perks package which includes pre-IPO options, annual cash bonuses, 401k matching, free parking or Seattle-area ORCA pass, tuition assistance, plus rewards for achievement and contribution. To support a healthy work-life balance we also provide a gym subsidy, wellness participation programs, and a generous vacation, sick, and holiday paid time off program in addition to a paid shutdown between the Christmas and New Year’s holidays.

Partner Therapeutics is an Equal Opportunity Employer and does not discriminate on the basis of race, color, religion, sex, age, national origin, veteran status, marital status, sexual orientation, gender identity, disability or any other category prohibited by local, state or federal law. This policy applies to all aspects of employment, including recruitment, placement, promotion, transfer, demotion, compensation, benefits, social and recreational activities, and termination.

Job Summary

JOB TYPE

Full Time

POST DATE

05/20/2022

EXPIRATION DATE

10/20/2022

WEBSITE

partnertherapeutics.com

HEADQUARTERS

Lynnwood, WA

SIZE

<25

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