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Quality Assurance Specialist II
2 months ago
The Quality Assurance Specialist II will play a key role in supporting the Northern California quality management customer request process for Life Science (LSG) and Clinical Diagnostics (CDG) products.
Daily activities will include:
- Facilitating the onboarding of suppliers to key customers.
- Supporting the intake, management, response, and closure of customer quality documentation requests.
- Coordinating and completing supplier survey questionnaires for customers across various business segments.
- Liaising with U.S. and International sales teams to prioritize high-priority customer requests.
- Coordinating product certificates of conformance, certificates of origin, declarations of conformity, and other applicable regulatory and statutory documentation requests.
Responsibilities:
- Supporting the creation of key product QMS survey response forms in collaboration with cross-functional subject matter experts to identify responses for frequently required customer requests.
- Facilitating the review and approval of customer change and/or quality agreements.
- Reviewing, verifying, and closing tasks in support of product and process change management file activities.
- Supporting marketing groups in drafting customer notifications.
- Reviewing manufacturing process deviations and non-conformances for potential notification of customers per applicable quality agreements.
Requirements:
- An associate degree or equivalent in Biology, Chemistry, or a related field.
- 2+ years' experience in a regulated manufacturing industry or an equivalent combination of education and experience.
- An understanding of GMP/ISO regulations (ISO 13485, MDSAP, FDA 820/210/211).
- A working knowledge of device/drug/biotech manufacturing processes.
- Detail-oriented, excellent organizational and project management skills, and the ability to multitask.
- Decision-making, time management, organization, communication, leadership, and computer skills.
- Proficiency in Microsoft Office, Visio, and Excel.
- Salesforce and SAP experience is a plus.