Associate Quality Partner Job at Roche and Genentech, Pleasanton, CA

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  • Roche and Genentech
  • Pleasanton, CA

Job Description

Description:

  • Onsite position - Local candidates
  • As an Operations Quality Associate Quality Partner, your primary responsibilities will be supporting document control, equipment management activities and visual inspection of finished good products.
  • You are accountable for ensuring your contributions are delivered in a way that lives up to our commitments to each other and the Roche Diagnostic Commitments.
  • You work as a strategic business partner to help contribute more to the team, customers and patients and help mitigate significant compliance issues within your area of influence.
  • Your contributions help lead to developing and producing safe, quality products and services that meet customer requirements throughout the entire lifecycle.
  • You push the boundaries to enable and implement smart, risk-based compliant processes that result in quick and efficient innovation.

Responsibilities:

  • Act as a Document Control coordinator (i.e. redlining documents, routing documents in electronic document management system, training users on document control process).
  • Support equipment management activities (i.e. scheduling vendors for calibrations, PM, and repairs, inducting new equipment, updating equipment status, monitoring equipment alarms).
  • Perform visual inspection of finished goods to ensure accuracy, completeness, appropriate release and control of products (review product information, generate Certificate of Analysis).
  • Support non-conformance investigations and corrective actions.
  • Compile and maintain Quality metrics to ensure compliance with quality system requirements and continuously promotes “Right First Time”.
  • Participate and implement process improvements to meet business needs. Drive innovation within your area of influence.
  • Responsible for performing activities as required to meet Operations Quality goals and objectives with direction as appropriate.
  • Communicating significant quality or regulatory issues and risks that may impact product quality or regulatory compliance in a timely manner.
  • Work day to day with limited supervision to correctly complete daily scheduled and unscheduled activities. Specific assigned tasks are completed independently.
  • Other duties as assigned.

Relevant Skills:

  • Proficient in Microsoft Word and Excel (redlining and formatting documents)
  • Basic understanding of Quality Management Systems such as Good Manufacturing Practices (cGMP) Good Documentation Practices, Production Controls, Training, etc
  • Familiarity with applicable local and international regulations
  • Experience with SAP, ERP systems a plus


Education/Experience:

  • Associates, Bachelor’s or Master’s Degree in Life Sciences or equivalent experience (preferably 3-5 years in biotech/pharmaceutical/medical device industry).

Who We Are

  • At Roche, we are passionate about transforming patients’ lives and we are fearless in both decision and action - we believe that good business means a better world.
  • We commit ourselves to scientific rigor, unassailable ethics, and access to medical innovations for all. We do this today to build a better tomorrow.
  • Quality is a competitive advantage for Roche. It allows us to deliver high-quality products to patients, ensures our right to operate, and helps us create value through process excellence and continual improvement efforts.
  • Quality is every patient’s right and every employee’s responsibility.

This is the pay range that Magnit reasonably expects to pay for this position: $35.00/hour-$45.00/hour

Benefits: Medical, Dental, Vision, 401K (provided minimum eligibility hours are met)

Magnit has an ongoing commitment to the diversity and inclusion of all team members. We believe that embracing diversity leads to innovation and helps address the needs of the business. We welcome individuals from different backgrounds, experiences, and cultures to join our team. We value this diversity and strive to create an inclusive environment that celebrates these unique perspectives, allowing you to contribute to your full potential. Finally, but most importantly, we expect all team members to be treated with dignity and respect.

If you have a disability and need an accommodation in relation to the online application process, please email us at Roche.Accommodations@magnitglobal.com

Job Tags

Contract work, Local area,

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