Senior Quality Specialist

Kelly Science, Engineering, Technology & Telecom; Sunnyvale (CA); On-site; USD 146,000 - 166,000; Full time

Benefits offered by this job

Kelly Standard Benefits

Job summary

A leading biotechnology firm seeks a Sr. Quality Specialist in Sunnyvale, CA, responsible for quality systems related to assay development. This role includes guiding product development teams to ensure compliance with FDA and ISO regulations. Ideal candidates will possess strong experience in quality assurance within the medical device or pharmaceutical fields.

Qualifications

• 5+ years of related experience for B.S. or 3+ years for M.S.
• Experience in assay development in medical devices or pharmaceuticals.
• Knowledge of cGMP, ISO, and FDA regulations mandatory.

Responsibilities

• Support quality systems activities related to assay development.
• Ensure compliance with FDA and ISO regulations.
• Provide technical expertise for post market investigations.

Skills

Quality Systems

Assay Development

Risk Management

Design Control

Technical Data Analysis

Microsoft Excel

Microsoft Word

Minitab

FDA Regulations Knowledge

Education

B.S. degree in Chemistry, Biology, or related field

M.S. degree in Chemistry, Biology, or related field

Job description

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Kelly Science, Engineering, Technology & Telecom provided pay range

This range is provided by Kelly Science, Engineering, Technology & Telecom. Your actual pay will be based on your skills and experience — talk with your recruiter to learn more.

Base pay range

$70.00/hr - $80.00/hr

Title: Sr. Quality Specialist

Location: Sunnyvale, CA

Job Type: 1-year Contract, Full-Time, On-Site (M-F: 1st Shift)

Compensation: $70-$80/hour (DOE) + Kelly Standard Benefits

Job Description:

The Sr. Quality Specialist is responsible for supporting quality systems activities related to assay development, especially, design control and risk management activities in accordance with FDA and ISO regulations. This position is part of the Product Lifecyle Quality group in R&D and reports to the Sr. Manager, Product Lifecyle Quality and will be onsite based, located in Sunnyvale, California.

Responsibilities:

• Participate as Quality representative on product development teams which includes providing guidance for Market Specification, Functional Specification, Design Verification, Design Validation, Test Method Validation, Risk Assessments, and Design Reviews; and provide guidance and decisions on product development activities to ensure continued compliance with internal procedures and applicable US FDA, EU IVDR, and other global standards.
• Provide design control guidance to junior NPI Quality specialists and provide technical oversight of product shelf-life/stability program.
• Fulfill all quality planning, stability, and risk management deliverables with feedback from cross-functional teams.
• Ensure required documentation is completed prior to new product launch, and coach product development teams to successful completion where necessary.
• Provide technical expertise for post market investigations and design changes, including documentation of investigations following standard out of specification SOPs and assessment of changes using design control methods.

Requirements:

• B.S. degree with 5+ years of related experience or M.S. degree with 3+ years of related experience, degree in Chemistry, Biology, or related physical or biological science field.
• Related work experience in Quality with a focus on assay development in a medical devices or pharmaceutical industry with applicable knowledge of cGMP, ISO, and FDA regulations (ISO 13485, ISO 14971, FDA 21 CFR 820 QSR)
• Experience in implementing design control and risk management, and product shelf-life activities.
• Experience with technical data and capable of making risk-based recommendations, taking into account broad perspectives that support both the regulations and the business.
• Adept with Microsoft Word, Excel, Visio, PowerPoint, and Minitab.
• Quality Systems/Quality Engineering background in molecular biology products or molecular diagnostic products utilizing PCR (preferred).

Seniority level

• Seniority level

  Mid-Senior level

Employment type

• Employment type

  Full-time

Job function

• Job function

  Science, Research, and Quality Assurance

• Industries

  Biotechnology Research, Medical Equipment Manufacturing, and Research Services

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