This position is part of the Hillsboro Individualized Therapies (HIT) team responsible for production of new modalities in the Pharma Technical Cell and Gene Therapy (PTC) organization, the position is 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.
Day Shift : Monday-Friday, 8 : 00 am - 5 : 00 pm
Contract duration (12 months possible extensions up to 36 months)
Pay rate $25 / hour
Responsibilities include sample collection, evaluation and data reporting, and coordination of required excursion response and restart activities.
Additional responsibilities include managing consumables and maintaining equipment.
Responsibilities :
- 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 activities
Qualifications / Requirements :
- B.S. / B.A. Degree in relevant scientific discipline or previous 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
- Ability to follow Quality standards
- Flexibility in problem solving and work hours to meet business objectives
- Work in a clean room environment. Prolonged periods of standing / sitting. Frequent lifting (up to 25lbs), bending, reaching, twisting.
Use of stepladders and pushcarts required
Genentech is an equal opportunity employer, and we embrace the increasingly diverse world around us. Genentech prohibits unlawful discrimination based on race, color, religion, gender, sexual orientation, gender identity or expression, national origin or ancestry, age, disability, marital status and veteran status.
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In this role, you will perform Environmental Monitoring (EM) and critical utility monitoring activities in support of the clinical manufacturing of CGT. Degree in relevant scientific discipline or previous experience performing Environmental Monitoring (EM) and knowledge of cGMP regulations. Partner...
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