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Associate Quality Partner

Pleasanton, CA 94588

Posted: 06/20/2024 Employment Type: Contract Industry: Quality and Regulatory Affairs Job Number: 11750 Pay Rate: $35.00 - $45.00 Remote Friendly: Onsite

Job Description

Our client develops, manufactures and supplies a wide array of innovative medical diagnostic products, services, tests, platforms and technologies.

Position Overview:

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 to the companies 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.

Job Requirements

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, Bachelors or Masters Degree in Life Sciences or equivalent experience (preferably 3-5 years in biotech/pharmaceutical/medical device industry).

Meet Your Recruiter

Lexie Pierce
Recruiter

As a Compass recruiter, Lexie brings in 15 years of experience in leadership and employee growth and development. She's incredibly passionate about helping candidates find and accept new opportunities, ultimately leading her to start her recruiting career in the life science industry. Her favorite part about connecting with Compass candidates and clients is witnessing the excitement the candidates exude and making an impact on their lives.

 

Outside of the office, Lexie enjoys going to the farmers' market on Saturdays with her son so she can find the best produce to use in her family dinners. She enjoys cooking, reading, knitting, restoring furniture, and spending time with her family and friends. Lexie is also passionate about supporting organizations that are looking to educate the community about Congenital Heart Defects (CHD).

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About Pleasanton, CA

Ready to embark on a fulfilling career journey in the vibrant region of Pleasanton, California? This picturesque city nestled in Alameda County offers a unique blend of suburban charm and exceptional growth opportunities for job seekers. Known for its charming downtown area with historic buildings, Pleasanton boasts a thriving arts scene with galleries like Firehouse Arts Center and Bankhead Theater. Indulge in the region's diverse cuisine, explore the scenic trails of Shadow Cliffs Regional Recreation Area, and catch a game of the Oakland Athletics at the nearby RingCentral Coliseum. Embrace the enchanting culture and endless possibilities that Pleasanton has to offer as you explore our curated job listings to find your perfect match. Let's kickstart your career journey in Pleasanton, CA today!