Quality Control Associate

Roche•Hillsboro, OR

3d•$52,600 - $78,200•Onsite

About The Position

This position is part of the Hillsboro Innovative Therapies (HIT) Analytical Development and Quality Control (ADQC) team responsible for supporting the development of new modalities in the Pharma Technical Cell and Gene Therapy (PTC) organization, the position based in Hillsboro, Oregon. PTC focuses on the development of cell and gene therapeutics (CGT) for the treatment or cure of various diseases. In this role, you will perform Environmental Monitoring (EM) and critical utility monitoring activities in support of the clinical manufacturing of CGT. The Position is located in Hillsboro, Oregon, On-site (occasional need to work overtime and on weekends).

Requirements

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 Microbiology, Biochemistry, Molecular Biology or relevant scientific discipline and experience is in pharmaceutical or biopharmaceutical industry.
Experience performing Environmental Monitoring (EM) and knowledge of cGMP regulations.
Demonstrated ability to work independently to accomplish tasks.
Strong verbal and written communication skills, ability to organize and present information both formally and informally.
Able to follow Quality standards.
Possess flexibility in problem-solving and work hours to meet business objectives.

Responsibilities

Sample collection, evaluation and data reporting, and coordination of required excursion response and restart activities.
Managing consumables and maintaining equipment.
Execute non-viable air, viable air, surface, and critical utility sample collection in a cleanroom and/or unclassified environment with documentation according to cGMP.
Partner closely with Quality Assurance to ensure the Environment and Utility Monitoring programs are in compliance with internal standards and regulations.
Use SOPs in full compliance with cGMP regulations and evolving expectations.
Develop new business processes to constantly improve ourselves.
Identify gaps, technical problems, deviations and discrepancies.
Notify Management of potential quality or regulatory issues that may affect product quality or regulatory compliance.
Receive and provide training.
Support the maintenance and compliance of operational areas.
Work to meet schedules, timelines, deadlines.
Perform any other tasks as requested by Management to support site and analytical activities.