Position Title: Quality Control Associate
Work Location: Hillsboro, OR 97124
Assignment Duration: 6 months (with extensions possible)
Work Arrangement: Onsite

Position Summary:
This position is part of the consolidated analytical development team responsible for supporting the development of new modalities in the newly created Pharma Technical Cell and Gene Therapy (PTC) organization, based in Hillsboro, Oregon. PTC focuses on the development of cell and gene therapies for the treatment or cure of various diseases. You will perform analytical development and quality control (QC) activities in support of the cell and gene therapy produced at HIT.

Key Responsibilities:
• Execute analytical method validation, and implementation in partnership with interdepartmental site colleagues and intradepartmental network colleagues to support GMP production at HIT.
• Implement and use SOPs, specifications, and testing methods in full compliance with cGMP regulations and evolving expectations.
• Embody PharmaTechnical lean principles and methods while fostering a continuous improvement mindset throughout the organization by practicing experimentation and learning.
• Develop new business processes to constantly improve ourselves.
• Perform analytical activities (e.g., assay transfer and assay validation) to meet project timelines.
• Write or review equipment qualification/maintenance life cycle, method implementation documents (protocols and reports) and procedures with input from senior team members.
• Perform technical review of data and assess against established acceptance criteria.
• Identify gaps, technical problems, deviations, and discrepancies.
• Participate in project teams and process improvement initiatives.
• Notify Management of potential quality or regulatory issues that may affect product quality or regulatory compliance.
• Perform a broad variety of basic and moderately complex tests with documentation according to cGMP.
• Receive and provide training.
• Perform equipment qualification/maintenance.
• Prepare and maintain standards, controls, stocks, cultures, etc. per established procedures.
• Support the maintenance and compliance of operational areas.
• Support internal and external audits and regulatory inspections.
• Work to meet schedules, timelines, deadlines.
• Perform environmental and critical utility monitoring, including sample collection, evaluation, and result reporting.
• Perform any other tasks as requested by Management to support analytical activities.

Qualification & Experience:
• B.S./B.A. Degree and two years of experience or Master’s degree plus one year experience or an equivalent combination of education and experience. Degrees are preferably in Chemistry, Biochemistry, Molecular Biology, or relevant scientific discipline, and experience is in the pharmaceutical or biopharmaceutical industry.
• Sound knowledge of cGMPs or equivalent regulations.
• Flow cytometry experience (Critical).
• GMP experience (Critical).
• Demonstrated ability to work independently to accomplish tasks.
• Strong verbal and written communication skills, ability to organize and present information both formally and informally.
• Demonstrated ability to apply knowledge of scientific theories, principles, and techniques used in analytical or biological test procedures.
• Ability to interpret and relate Quality standards for implementation and review.
• Flexibility in problem solving and work hours to meet business objectives.
• Work in an office and laboratory environment. Prolonged periods of standing/sitting at lab bench top. Frequent lifting (up to 25lbs), bending, reaching, twisting. Use of stepladders and pushcarts required.
• Pass visual screening, as required.
• Ability to travel to other sites, as required.

Working Conditions & Physical Demands:
• Work in an office and laboratory environment. Prolonged periods of standing/sitting at lab bench top. Frequent lifting (up to 25lbs), bending, reaching, twisting. Use of stepladders and pushcarts required.

Additional Information:
• Onsite Medical/Vision exam required as part of onboarding.

 
 
At SPECTRAFORCE, we are committed to maintaining a workplace that ensures fair compensation and wage transparency in adherence with all applicable state and local laws. This position’s starting pay is: $ 29.68/daily.