Supervisor, Medical Equipment Planning Specialist
3 weeks ago
Job Summary
The Quality Control Laboratory Operations Manager will oversee the daily operations of the QC PT/CB lab, supporting testing service needs for Manufacturing, Validation, Engineering & other Quality groups as needed.
This role will develop and implement Quality Control laboratory systems that support metrics / data trending, management review, subcontractor qualification and audits for Leukine testing.
The successful candidate will be responsible for overseeing departmental training program, supporting execution and continuous improvement for Drug Product, Bulk Drug Substance, In-Process and Raw Materials program(s).
Key responsibilities include identifying and prioritizing implementation of opportunities to improve Quality processes and practices, working collaboratively with inter-department and cross-functional teams to lead improvement implementations in a timely, effective and compliant manner.
The Quality Control Laboratory Operations Manager will review emerging and updated regulations and guidelines, staying current on industry trends and develop and implement gap remediation strategies with guidance from QC Manager, as necessary.
Responsibilities
- Oversee daily operations of QC PT/CB lab
- Develop and implement Quality Control laboratory systems
- Support execution and continuous improvement for Drug Product, Bulk Drug Substance, In-Process and Raw Materials program(s)
- Identify and prioritize implementation of opportunities to improve Quality processes and practices
- Work collaboratively with inter-department and cross-functional teams to lead improvement implementations
- Review emerging and updated regulations and guidelines
- Develop and implement gap remediation strategies
Requirements
- Bachelor's degree in Chemistry, Biochemistry, Biology, Cellular Biology or related scientific field
- ~5+ years QC and/or laboratory experience in a cGMP Manufacturing Environment or equivalent
- Strong written and oral English communication skills
- Practical understanding of principles of project management
- Experience implementing continuous improvement projects
- Proven ability to lead teams and/or projects effectively and to ensure GMP compliance
What We Offer
Partner Therapeutics offers a competitive compensation and benefits package, including pre-IPO options, cash bonuses, 401k matching, free parking or Seattle-area ORCA pass, tuition/educational assistance, plus rewards for achievement and contribution.
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 (dependent on business conditions).
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.
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