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Quality Control Specialist
2 months ago
Job Summary:
BEPC Inc. - Business Excellence Professional Consulting is seeking a highly skilled QC Lab Technician ll to join our team in Hillsboro, OR. As a key member of our Quality Control organization, you will be responsible for performing and reviewing various assays in support of In-Process intermediates, drug substance, drug product, and stability sample testing in a cGMP environment.
Responsibilities:
- Perform and review biochemical assays using analytical techniques and instrumentation, such as high-performance liquid chromatography (HPLC) and mass spectroscopy.
- Interpret data, troubleshoot assay failures, and equipment issues while adhering to strict guidelines on cGMP documentation.
- Support cycle development, performance qualifications, method transfers, discrepancy/out-of-specification investigations, and collaborate with external groups to identify improvement opportunities in technology and business process.
- Follow company policies and procedures, maintain a state of inspection readiness, and operate glassware washer and autoclave.
- Independently manage competing priorities with limited instruction, perform environmental monitoring and water sampling, and provide assistance to customers in support of departmental functions.
- Participate in the design and implementation of department and cross-functional initiatives, apply basic theory and technical principles to address moderately complex problems, and troubleshoot and initiate the resolution of Quality issues.
- Serve as a technical subject matter expert (SME) in support of department functions, sign documents for activities as authorized and described by Genentech policies, procedures, and job descriptions, and be accountable for behaviors as described in Genentech's Core, Common, and Critical Competencies.
Qualifications:
- B.A. or B.S. degree (preferably in Life Science) and at least 2-3 years' experience in the pharmaceutical, biopharmaceutical, or related industry, or an equivalent combination of education and experience.
- Hands-on industrial laboratory experience with analytical techniques such as HPLC, Mass Spectroscopy.
- Strong verbal and written communication skills, ability to organize and present information in informal and formal group settings, and demonstrated ability to apply knowledge of scientific theories, principles, and techniques used in analytical or biological test procedures.
- Routinely exercises sound judgment, reasoning, and problem-solving, capable of working under moderate supervision, and determining own short-term priorities.
Work Environment/Physical Demands/Safety Considerations:
Work in office and laboratory environment, lift up to 25lbs may be required, ability to sit, stand, and move within workspace for extended periods, and may be required to sit at a computer terminal for extended periods.
