Quality Control Analyst III (Onsite)

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, 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.

PRIMARY RESPONSIBILITIES

LABORATORY TESTING (~75%)

• 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
• Troubleshoot method/equipment issues to find root cause and correct/prevent re-occurrences
• Qualify critical reagents, materials, standards and controls to ensure suitable for intended use
• 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
• May represent QC on internal/external teams
• Perform method qualification/validation activities to support the product or method lifecycle
• Provide QC subject matter expertise on QC methods, equipment and software
• Propose solutions to improve laboratory testing/method performance
• 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
• Resolves "stuck" issues by ensuring timely issue escalation to Leadership and cross-functional teams: Applies learning from these events and leads the creation of new/updated systems, processes, programs to prevent similar situations in the future.
• Through self-education and external networking/participation in industry and professional organizations keeps abreast of current industry trends, compliance requirements, and best-of-class technologies relating to area of responsibility. Actively applies learned best practices, knowledge, and benchmarking to PTx projects and solutions.
• Pursues participation or leads project teams outside normal course of work (i.e. "collateral duties") as they become available to support personal growth, connection, and business needs.
• 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.

KNOWLEDGE, SKILLS, ABILITIES

Required:

• Mastery of 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 proposes solutions to improve compliance
• Excellent verbal and written communication skills
• Ability to work with multiple-cross-functional departments
• Strong critical thinking, analytical, and problem-solving skills with the proven ability to formulate solutions to propel the organization forward.
• Resourceful with proven ability to lead, manage, and leverage an extensive internal network of stakeholders, team members, and external resources to plan and resolve issues. Strong, collaborative relationship management and interpersonal skills required to quickly gain confidence of stakeholders and team members.
• Possesses strong organizational and prioritization skills to maintain a high level of productivity and priority-setting in order to complete assignments on-time and on-budget.
• 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.

Preferred:

• Experience in potency testing, bioassay, and/or other plate-based methods (e.g. ELISA)
• Proven ability to proactively identify and implement continuous improvement projects
• Has the ability to take ownership and lead a program within the QC department
• Project management experience or formal training.

EXPERIENCE & EDUCATION

Required:

• High School Diploma or GED.
• 4+ years of prior working experience in a regulated environment (GMP, GLP, etc.)
• Excellent communication skills, both written and oral
• Proficiency with MS Office products, especially Word and Excel.

Preferred:

• B.S. or equivalent degree in science (Biology, Chemistry, Biochemistry, etc.) or related field (Chemical Engineering, etc.) strongly preferred
• Experience with NuGenesis 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 III is $80,000 - $100,000. 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 Hybrid or Remote workplace program for many roles. We also offer a highly competitive compensation and benefits package, including an annual discretionary cash bonus and a 401(k) matching program. Partners in the Seattle area can take advantage of a free ORCA pass, and we also provide tuition and continuing education assistance to support ongoing professional development. Recognition for outstanding contributions and achievements is a core part of our culture

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.