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Quality Systems Specialist
Quality Systems SpecialistActalent • San Mateo, CA, US
Quality Systems Specialist

Quality Systems Specialist

Actalent • San Mateo, CA, US
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Quality Systems Specialist

The Quality Systems Specialist is responsible for managing change controls related to manufacturing product, process, equipment, facility, and computerized systems. This role requires adherence to key performance indicators and a commitment to 'right the first time' principles. The specialist will independently review, initiate, complete, and document critical, major, and minor change controls, managing both local and global change controls and associated activities in GxP operations.

Responsibilities

  • Facilitate cross-functional meetings with stakeholders and leadership to ensure alignment with proposed changes and compliance with Quality Management System (QMS) expectations.
  • Navigate complex change review discussions, facilitating decisions regarding approach and follow-up actions, and document these evaluations.
  • Support management and monitoring of change records for adherence to organizational or departmental metric targets and maintain associated tracking tools and databases.
  • Assist in the management review process by developing and generating quality system metrics and trends, escalating issues as necessary.
  • Contribute to the maintenance and improvement of quality systems processes as needed.
  • Collaborate directly with operating entities and internal clients to ensure follow-up on change tasks.

Essential Skills

  • 6+ years of relevant experience in a GMP environment for biologics manufacturing with a BS or BA, including mandatory change control experience.
  • 4+ years of relevant experience with a MS degree.
  • Change control experience from a regulated industry such as medical device, pharma, nutraceuticals, or vitamins, with FDA-related knowledge.
  • Strong communication skills, good time management skills, and attention to detail.
  • Knowledge of good technical writing.

    • Work Environment

    The role offers a hybrid work environment with required onsite presence on Tuesdays, Wednesdays, and Thursdays, while offering work-from-home flexibility on Mondays and Fridays. This position provides an opportunity to work with end-to-end change control management in a streamlined capacity for the organization. Initially a one-year role with potential for renewal based on business needs.

    Job Type & Location

    This is a Contract position based out of Foster City, California.

    Pay and Benefits

    The pay range for this position is $50.00 - $65.00 / hr. Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following :

  • Medical, dental & vision
  • Critical Illness, Accident, and Hospital
  • 401(k) Retirement Plan Pre-tax and Roth post-tax contributions available
  • Life Insurance (Voluntary Life & AD&D for the employee and dependents)
  • Short and long-term disability
  • Health Spending Account (HSA)
  • Transportation benefits
  • Employee Assistance Program
  • Time Off / Leave (PTO, Vacation or Sick Leave)

    • Workplace Type

    This is a hybrid position in Foster City,CA.

    Application Deadline

    This position is anticipated to close on Nov 4, 2025.

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    Quality Specialist • San Mateo, CA, US