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Senior QC Analyst/QC Associate

Vacaville, California


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The Position

Please note there are 2 available positions

Summary

Conducts routine and non-routine laboratory equipment maintenance. Performs sample management maintenance including but not limited to raw materials, in-process items, finished product and stability program according to established operating procedures. Revises and updates standard operating procedures as needed. May perform special projects on analytical and instrument problem solving. Participates in the preparation of investigations, summaries and reports.

Job Responsibilities

Perform routine and semi-routine assignments that are complex in support of lab operations:

  • Perform maintenance on Laboratory equipment in support of laboratory operations

  • Exhibit detail oriented documentation skills to ensure Right-First-Time operations

  • Identify and support resolution of technical problems

  • Coordinate with customers to support operation activities

  • Prepare basic and complex reagents as assigned.

  • Create and maintain finite schedules.

  • Create and maintain work in progress tracking tool.

  • Receive and provide training.

  • Identify discrepancies, participate in quality investigations and CAPA (corrective actions preventive actions) initiative as needed

  • Actively participate in group and project teamwork; project and process improvement.

  • Good understanding of global systems and cGMP Compliance requirements/regulations

  • Assist in preparing for internal and external inspections by ensure Laboratory is inspection ready at all times.

  • Ability to create/revise lab associated documents e.g. testing procedures, FNs, SOPs.

  • Perform other duties as requested by managers to support Quality activities

Job Requirements

Education/Experience/Knowledge/Skills/Competencies:

  • B.S./B.A degree, or 2-3 year experience in the related industry, or an equivalent

  • combination of education and experience.

  • Knowledge of cGMP or equivalent regulations.

  • Strong verbal and written communication skills, ability to organize and present information both formally and informally.

  • Capable of completing assigned responsibilities and keeping management informed of status.

  • Routinely exercises sound judgement, reasoning, and problem solving.

  • Ability to work under minimal supervision to complete assigned tasks in a timely manner.

  • Takes responsibility, drives results, and achieve expected outcomes.

  • Experience with SAP.

Work Environment/Physical Demands/Safety Considerations

Physical Requirements:

  • Prolonged periods of standing at laboratory bench top.

  • Frequent lifting (up to 20 lbs.), bending, reaching, twisting.

  • Use of step ladders and push carts required.

  • Ability to work off shifts and/or weekends.

Note: Position may involve use of reagents and other chemical compounds, including but not limited to

acetonitrile, chlorine, acids and bases, biologic toxins, microorganisms and potent compounds.

Who We Are

Genentech, a member of the Roche group and founder of the biotechnology industry, is dedicated to pursuing groundbreaking science to discover and develop medicines for people with serious and life-threatening diseases. To solve the world's most complex health challenges, we ask bigger questions that challenge our industry and the boundaries of science to transform society. Our transformational discoveries include the first targeted antibody for cancer and the first medicine for primary progressive multiple sclerosis.

Diversity and Inclusion (D&I) are critical to the success of our company and our impact on society. We believe that by championing diversity of background, thought and experience, we can foster a sense of belonging and provide an environment where every employee feels valued, included, and able to contribute their best for the patients we serve. We’re focused on attracting, retaining, developing and advancing our people to their full potential by rewarding bold ways of thinking and integrating inclusive behaviors into every aspect of our work.

The next step is yours. To apply today, click on the "Apply for this job" button.

Genentech is an equal opportunity employer & prohibits unlawful discrimination based on race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, disability, marital & veteran status. For more information about equal employment opportunity, visit our Genentech Careers page.


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