Quality Control Analyst/Senior Quality Control Analyst (Onsite)

Quality Control Analyst/Senior Quality Control Analyst (Onsite)
Quality and Regulatory Lynnwood, Washington
Description
QUALITY CONTROL ANALYST/SENIOR QUALITY CONTROL ANALYST
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 DESCRIPTION
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 reoccurances 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 Deviaitons 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) Minimum of 2 years of relevant laboratory experience required; level depends on directly relevant experience Prior working experience in a regulated environment (GMP, GLP, etc.) is preferred Proven experience in Potency/Bioassays, HPLC/CE or other analytical techniques strongly preferred