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