Quality Control Analyst II (Onsite)

Partner Therapeutics•Lynnwood, WA

3d•Onsite

About The Position

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.

Requirements

Proficiency with different types of analytical instrumentation (HPLC, UV-vis, etc.)
Track record of successfully working with a high degree of independence, initiative, and reliability.
Collaboration on writing SOPs, Laboratory Investigations, Change Controls, and Deviations
Recognizes patterns/trends and helps propose solutions to improve compliance
Excellent verbal and written communication skills
Ability to work with multiple-cross-functional departments
Excellent time management skills, ability to plan efficient daily/weekly schedules
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.
Proficiency with MS Office products, especially Word and Excel essential; ability and willingness to quickly adopt other job-specific applications will be necessary.
High School Diploma or GED.
2+ years of prior working experience in a regulated environment (GMP, GLP, etc.)
Solid communication skills, both written and oral
Proficiency with MS Office products, especially Word and Excel.

Nice To Haves

Experience in potency testing, bioassay, and/or other plate-based methods (e.g. ELISA)
Proven ability to proactively identify and implement continuous improvement projects
B.S. or equivalent degree in science (Biology, Chemistry, Biochemistry, etc.) or related field (Chemical Engineering, etc.) strongly preferred
Experience with NuGenesis preferred

Responsibilities

Perform release and stability testing according to SOPs for raw materials, in-process intermediates, BDS and DP
Peer review complex assay documentation to ensure completeness and good documentation practices
Participate in the qualification of critical reagents, materials, standards and controls
Proactively identifies and escalates potential roadblocks.
Investigate and document deviation, determine root cause and product impact to propose corrective/preventive actions
Train other staff on methods/techniques
Perform method qualification/validation activities to support the product or method lifecycle
Propose solutions to improve laboratory testing/method performance
Perform other additional job-related duties, as required
Maintains an awareness, responsibility and accountability for cGMP and SOP requirements
Follows safety precautions in the laboratory
Maintains training requirements
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.