Senior Supplier Quality Associate
300 Bel Marin Keys Blvd. Novato, CA 94949
Bayside Solutions is seeking a Senior Supplier Quality Associate to be part of our client’ s team in the North Bay. This is an opportunity to work with the largest privately held pharmaceutical corporation in the world and ranks among the world' s 20 leading pharmaceutical corporations.
Our Client’ s culture is highly collaborative, offers an environment that encourages employees to expand their knowledge in order to make a profound impact on patients’ lives. This could explain why their company has been recognized as one of the “ Top Twenty Employers” in biotechnology and pharmaceuticals by Science Careers.
Our Company Bio: Bayside Solutions was founded in 2001, Bayside was recognized as one of the fastest growing professional staffing companies in Northern California. The numbers tell the story: We have close to a 100% client retention rate, 700% growth in four plus years and over 95% repeat business. Our dedication to building partnership relationships with both our clients and our recruits is the key to our phenomenal success.
You can find additional information on our company website at www.baysidesolutions.com.
Sr. Supplier Quality Associate
- An opportunity to join a patient-focused organization that is driven to develop, manufacture and commercialize medicines to treat life threatening conditions.
- Work for a company that is local to the bay area and recognized as a leader of innovation.
- Competitive compensation commensurate with experience.
- This position is eligible for medical, vision, dental benefits, paid sick time, and 401K.
Summary of Responsibilities:
- Provide support and oversight for new and actively managed Supplier Change Notifications (SCNs) and supplier investigations.
- Participate, with potential to facilitate, in cross-functional Supplier Quality meetings.
- Support development of Supplier related policies, and continuously evaluate and improve practices and systems to coordinate with validation, documentation, and regulatory systems. Strive toward constant improvement of systems in order to maintain compliance cGMP requirements for work performed.
- Assist in development, implementation, and enforcement of departmental policies and procedures.
- Participate in inspection preparation, train employees in focus areas and participate in regulatory inspections.
- Maintain current knowledge of industry standards and regulatory requirements for products developed or manufactured by BioMarin and for Supplier related approaches utilized at BioMarin.
- Other duties as assigned.
Summary of Qualifications:
- BA or BS in a technical discipline (physical or biological sciences).
- Experience with TrackWise preferred.
- Experience working with international project teams preferred.
- 5+ years’ experience in a GMP regulated environment, with exhibited knowledge and proficiency working within quality systems, specifically Change Control.
- Strong ability to comprehend technical information related to raw material, process and regulatory expectations
- Proficiency with standard software applications, including MS Excel, Adobe Acrobat
- Understanding and familiarity with FDA, European, PMDA guidelines
- Exceptional organizational, spelling, grammar and typing skills.
- Effective leadership and communication skills.