Fremont, California

Quality Assurance Manager, East Bay San Francisco

We're seeking an experienced Quality Assurance Manager with strong project management skills and 5+ years of experience in biologics or pharmaceutical manufacturing. If you're looking for a new opportunity with work-life balance, apply today for consideration!

Duties & Responsibilities

  • Writes, reviews, and approves Standard Operating Procedures, Controlled Job Aides, Control Procedures, Quality Standards, etc.
  • Participate as subject matter expert in deviation management investigations, CAPA and effectiveness check processes for continuous improvement and inspection readiness.
  • Performs review and approval for CAPAs, commitments, change requests, investigative protocols, and final reports.
  • Author, review and approve Change Control documentations for complex validation, equipment, facility/utility and/or automation changes.
  • Update Quality Management System (QMS) with improvements and fixes.
  • Leverage technical experience to streamline the review and oversight process to enable education of system users and assuring proper DI enforcement by being an SME on various systems and their capabilities.
  • Provide Quality oversight of commissioning and qualifications related to computerized system, utilities and/or software associated with GMP equipment to ensure compliance and adherence with procedures, cGMP, and ISPE GAMP guidelines and regulations in collaboration with Validation, Engineering, Operation, Quality control, and external partners.
  • Review/Approve validation related system lifecycle documents (user requirements, functional and design specifications, qualification protocols/reports, plans, trace matrices, etc.) to support qualification projects as required per current Good Manufacturing Practices (cGMPs).
  • Review/Approve engineering, facilities, and quality documentations as needed.
  • Develop audit strategies for vendors and service providers used for GMP production.
  • Manage the life cycle of vendor qualification, comprised of initial vendor qualification and re-qualifications, maintaining an approved supplier/service provider list.
  • Completes training to become a qualified auditor and perform/assist in internal, customer and regulatory audits by preparing documentations associated with GMP Systems and processes.
  • Collaborates with other departments (Facilities & Engineering, Technical Operations, Clinical Operations, Quality Control, and IT) to ensure quality standards are in place.
  • Provides coaching and guidance to new personnel and to Quality Specialists who are training new personnel.
  • Facilitate a continuous improvement culture with other departments.

Requirements

  • Bachelor's degree in Engineering, Life Sciences, or related discipline with 5+ years of relevant experience, or combination of experience and relevant advanced degree.
  • In-depth understanding of technical documentation
  • Flexible mindset for a dynamic environment.
  • Strong project management capabilities.
  • Ability to independently evaluate technical situations and propose potential solutions.
  • Ability to communicate clearly and professionally in writing and verbally.
  • Flexibility with work hours to meet business needs.
  • Strong analytical and problem-solving skills

If you’re unable to apply through the website, please email your resume in Word format and position title to JEND557@kellyscientific.com.



Why Kelly®?

Kelly® Science & Clinical is your connection to premier scientific and clinical companies looking to hire talented people just like you. Every day, we match science professionals with dream jobs that fit their skills and interests—it’s the way we think job searching should be. Nearly 100 percent of our science recruiters have a professional background/education in science, so we know a thing or two about the science market and how to get you noticed.

About Kelly®

At Kelly, we’re always thinking about what’s next and advising job seekers on new ways of working to reach their full potential. In fact, we’re a leading advocate for temporary/nontraditional workstyles, because we believe they allow flexibility and tremendous growth opportunities that enable a better way to work and live (plus, did we mention we provide a ton of benefits?). Connecting great people with great companies is what we do best, and our employment opportunities span a wide variety of workstyles, skill levels, and industries around the world.

Kelly is an equal opportunity employer committed to employing a diverse workforce, including, but not limited to, minorities, females, individuals with disabilities, protected veterans, sexual orientation, gender identity. Equal Employment Opportunity is The Law.

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Fremont, California

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