Quality Systems Specialist

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

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 - $60.00 / 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 :