QC Technician II

2 weeks ago

Hillsboro, United States Tailored Management Full time
QC Technician II
Location: Onsite Hillsboro, Oregon
Shift: Day Shift during training for 2 months - Monday to Friday, 8:00 am to 4:30 pm
After training - pivots to Sunday to Wednesday, 4 x 10, 7:00 am to 5:30 pm.
Pay: $21-26 pay rate is set based on years of experience
Duration: 6 months to start, extension up to 3 years depending on business need and performance

Responsibilities include performing and reviewing a variety assays in the Quality Control organization in support of In-Process intermediates, drug substance, drug product and stability sample testing in a cGMP environment.
Specifically, biochemical assays, using analytical techniques and instrumentation, such as high performance liquid chromatography (HPLC) and mass spectroscopy. The QC Associate II must be able to interpret data troubleshoot assay failures and equipment issues while adhering to strict guidelines on cGMP documentation. In addition the individual will 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.

Responsibilities:
  • Follow company policies and procedures. Maintain a state of inspection readiness.
  • Operate Glassware washer and autoclave.
  • Independently manage competing priorities with limited instruction. Perform environmental monitoring and water sampling.
  • 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.
  • Troubleshoot and initiate the resolution of Quality issues by fostering effective interdepartmental and cross functional partnerships.
  • Serve as a technical subject matter expert (SME) in support of department functions.
  • Sign documents for activities as authorized and described by company policies, procedures and job descriptions.

Qualifications: Education, Experience, Knowledge and Skills:
  • 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 informal and formal group setting.
  • 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 work space for extended periods. May be required to sit at a computer terminal for extended periods.

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