We are a recruiting company EasyHiring, which is looking for candidates for our partners for a position Manager, QC Systems and Services in Alderwood Manor, WA for work in Bothell, WA

This position is responsible for the harmonization, life-cycle management and continuous improvement of all GMP quality system elements within the Laboratory Systems technology platform including but not limited to LabWare. In this role, the incumbent will serve as the primary representative for site system deployment related activities and cross-functional partnerships and collaborations. This is a highly visible role with Cellular Therapy Global responsibility and cross functional influence that has a high degree of impact on departmental performance, broad quality initiatives, Quality Control, Quality Operations and the Business.

Shift Available:

• Monday - Friday, Hybrid Day Shift (8 a.m. - 5 p.m. PST)

Responsibilities:

• Responsible for owning a process within the QC Systems organization. West Coast Site Lead would be responsible for CELabs west coast operations.
• Subject matter expert \ in a system process, supporting system deployment across CTO.
• Anticipate and perform complex troubleshooting and problem solving independently.
• Perform data verification, data review and review of GMP documentation for multiple systems (general and complex) and/or products.
• Drives/Own project, CAPA and deviation/ investigation related tasks and/ or continuous improvement efforts.
• May represent the department in regulatory inspections (internal and external audits).
• Train and mentor others on multiple QC system modules, processes and procedures.
• Cross trained on business and technical aspects of the QC Systems organization.
• Author and review/ revise technical documents such as test methods, SOPs, specifications, trend reports and/or sample plans as appropriate.
• Master Data Delivery within the timelines set forth by the SLA/Business
• Responsible for Site Issue and Risk Management with respect to CTO systems under the Network QC umbrella.
• Site Coordination of CELabs Go-live activities and business workstreams.

Knowledge & Skills:

• Ability to accurately and completely understand, follow, interpret and apply Global Regulatory and cGMP requirements.
• Demonstrated technical writing skills.
• High problem-solving ability/mentality, technically adept and logical.
• Ability to communicate effectively with peers, department management and cross-functional peers about task status, roadblocks and needs.
• Ability to work in a fast-paced team environment, meet deadlines, and prioritize work.
• Advanced knowledge of LIMS, ELN and/or Cellular Therapy business process highly preferred.

Basic Requirements:

• Bachelor’s degree required. An equivalent combination of education and experience will be considered.
• 3-5 years of Project Management experience.
• 3-5 years of Systems Management experience (including systems deployment).
• 3 years of Technical Writing skills.
• 3 years of Master Data experience.
• 3 years of Cell Therapy experience.
• Strong communication skills.

Preferred Requirements:

• Advanced degree in Science field.
• People Leadership experience.

The starting compensation for this job is a range from $92,000 - $115,000​, plus incentive cash and stock opportunities (based on eligibility).

The starting pay takes into account characteristics of the job, such as required skills and where the job is performed. Final, individual compensation is decided based on demonstrated experience.

Job Type: Full-time

Work Location: On the road