Quality Control Analyst I

QUALITY CONTROL ANALYST I - ANALYTICAL TESTING (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 Department is responsible for all testing related to the manufacturing and release of Leukine. These activities include testing raw materials, process intermediates, Bulk Drug Substance ("BDS"), 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.

PRIMARY RESPONSIBILITIES

LABORATORY TESTING (~75%)

• Performs release and stability testing according to Standard Operating Procedures ("SOPs") for raw materials, in-process intermediates, BDS, and DP.
• Peer reviews assay documentation to ensure completeness and good documentation practices ("GMP").
• Troubleshoots method/equipment issues to find root cause and correct/prevent reoccurrences.
• Qualifies critical reagents, materials, standards and controls to ensure suitability for intended use.
• Investigates and documents deviation, determines root cause and product impacts to propose corrective/preventive actions.
• Collaborates on writing SOPs, Laboratory Investigations, Change Controls, and Deviations.
• Proposes solutions to improve laboratory testing/method performance.

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.
• Adheres to all applicable regulations and requirements including compliance with internal SOPs, GMP, Health and Safety, WISHA/OSHA, regulatory compliance, company policies, and employment-related laws and statutes.
• Successfully completes all mandatory Quality and Compliance training within required timeframes.
• This job description is not intended to be all-inclusive. Partners may be required to perform other related duties as required to meet the ongoing needs of the organization.

KNOWLEDGE, SKILLS, ABILITIES

Required:

• Ability to perform basic bench top chemistry tests.
• Demonstrated flexibility, adaptability, reliability, and initiative when encountering changing priorities.
• Proven ability to work independently as well in a team environment.
• Excellent soft skills including a bias towards action, 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 changes and challenges.
• Solid English language communication skills, both oral and written, are required for this highly collaborative role. Willingness and ability to clearly express opinions and ask questions. Comfortable actively participating in cross-functional meetings.
• Solid software skills essential including Word and Outlook; ability and willingness to quickly adopt other job-specific applications will be necessary.

Preferred:

• Experience with different types of analytical instrumentation (HPLC, UV-vis, etc.).
• Experience with cell culture and cell-based assays.

EXPERIENCE & EDUCATION

Required:

• High School Diploma or GED.
• 1+ years of relevant work experience, preferably in a laboratory setting. An applicable Associate or BS/BA degree can substitute for the 1+ years of work experience requirement.

Preferred:

• B.S. or equivalent degree in science (Biology, Chemistry, Biochemistry, etc.) or related field (Chemical Engineering, etc.) strongly preferred.
• 1+ years of prior working experience in a regulated environment (GMP, GLP, etc.) is preferred.

PTx is committed to the principles of competitive and pay equity for all of our Partners. The current pay range for the Quality Control Associate 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.