Position Title: Associate Quality Partner

Location: Pleasanton, CA 94588

Duration: 12 Months

Pharmaceutical/ Medical Device background is required.

SAP/ ERP/ QMS experience.

At least Associates Degree is required

Job Description:

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 company. 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.

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).

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.