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Quality partner
2 months ago
Title: Associate Quality Partner
Location: Pleasanton, CA 94588 - ONSITE
Duration: 12+ Months contract role
Pay Rate: $35.00 - $45.00/Hour.
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.
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.
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.
- Workday 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).
Pay Rate & Benefits:
- This is the pay range that Magnit reasonably expects to pay for this position: $35.00/hour-$45.00/hour on W2.
- Benefits: Medical, Dental, Vision, 401K (provided minimum eligibility hours are met)
QUALIFICATION/ LICENSURE :
Work Authorization : Green Card, US Citizen
Preferred years of experience : 3+ Years
Travel Required : No travel required.
Shift timings: 9 AM to 5 PM
