Quality Control Analyst I - Biological and Facilities Testing (Onsite)

Quality and Regulatory Lynnwood, Washington


Description

QUALITY CONTROL ANALYST I (ONSITE)

Partner Therapeutics (PTx) is a commercial biopharmaceutical company committed to improving the lives of patients with cancer and other serious diseases. Our dedicated team brings a rigorous approach to science, establishes deep partnerships with medical and scientific communities, and works tirelessly to expand potential treatment options and address unmet medical needs.

POSITION SUMMARY

The Quality Control Biological and Facilities Testing group supports manufacturing activities at the Northpointe Facility by detecting, quantifying and identifying possible contaminants that may interfere with the quality of the product during the different stages of the manufacturing process. The group supports the environmental and critical utility monitoring program of the production facility and support areas. The QC - BFT group performs key microbiological assays supporting BDS, cell bank, and drug product release. The QC - BFT group routinely interacts with production, engineering, validation and other QC groups.

PRIMARY RESPONSIBILITIES

  • This individual will typically report to the Supervisor/Sr. Supervisor Quality Control and will contribute to general operations and testing of the QC - BFT lab. The Analyst works independently under general supervision, but will participate with the QC team to meet group goals. Primary responsibilities include, but are not limited to, the following:
  • Performs critical utility monitoring of water, steam, compressed air, and compressed gas.
  • Performs environmental monitoring within facility, including surface, particulate and viable air samples.
  • Performs endotoxin and bioburden testing.
  • Responsible for receipt and disposal of samples in the QC lab.
  • Autoclaves laboratory equipment in preparation for sampling and testing.
  • Troubleshoots assay and instrument problems with Laboratory Supervisor.
  • Enters data in MODA and Observa databases, as necessary.
  • Provides general maintenance of lab equipment and Controlled Temperature Units (CTU).
  • Participates in writing and revising Standard Operating Procedures, protocols, and assists with excursion investigations.
  • Maintains logbooks and log sheets.
  • Ensures labs are clean and safe (in compliance with cGMP) and properly stocked.
  • Participates in the qualification of equipment, methods, and processes.
  • Participates and perform special duties and projects assigned to the QC Microbiology team.
  • Performs work that consistently requires independent decision making and the exercise of independent judgment and discretion.
  • This job description is not intended to be all-inclusive. You may be required to perform other related duties as required to meet the ongoing needs of the organization.

KNOWLEDGE, SKILLS, ABILITIES

Required:

  • Proficiency with Microsoft Office products, especially Word and Excel.
  • Solid English communication skills, both written and oral, are required for this highly collaborative role.
  • Strong organization and planning skills.
  • Excellent soft skills including a bias towards action, at ease with escalating stuck issues, possesses the ability and willingness to give and receive constructive feedback, is comfortable working within a diverse team and across multiple functions, exhibits a consistently constructive attitude, and is adaptable and at ease with handling unexpected challenges.

EXPERIENCE & EDUCATION

Required:

  • High School Diploma or GED.
  • Experience working in a laboratory setting.

Preferred:

  • Associate degree in related life sciences discipline.
  • BA/BS degree in Microbiology, Biology, Chemistry, Biochemistry or related life sciences discipline or equivalent. 
  • 2+ years of directly relevant quality control experience in a regulated and relevant environment.
  • Experience with environmental monitoring (e.g., water bioburden testing) strongly preferred.
  • Experience working in a cGMP lab environment.

PTx is committed to the principles of competitive and pay equity for all of our Partners. The current pay range for the Quality Control Analyst I is $57,000 - $72,000. Offers are made within the base pay range applicable at the time. Your salary will vary depending on several factors including your qualifications and experience.

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.