Quality Systems Specialist

Quality Systems Specialist

The Quality Systems Specialist manages and optimizes change control processes across manufacturing products, processes, equipment, facilities, and computerized systems to support strategic, tactical, and operational quality goals. This role ensures robust oversight of GxP operations, maintains compliance with current Good Manufacturing Practices (cGMP), and contributes to the continuous improvement of the quality management system.

Responsibilities:

• Manage change controls related to manufacturing products, processes, equipment, facilities, and computerized systems to support key strategic, tactical, and operational objectives.
• Independently review, initiate, complete, and thoroughly document critical, major, and minor change controls in both local and global systems for GxP operations.
• Facilitate cross-functional meetings with stakeholders and leadership to align on proposed changes and ensure compliance with quality management system expectations.
• Lead complex change review discussions, guide teams to a common decision on approach and follow-up actions, and accurately document decisions, evaluations, and rationales.
• Support management and monitoring of change records to ensure adherence to organizational and departmental metric targets, maintaining associated tracking tools and databases.
• Develop and generate quality system metrics and trending reports to support the management review process and escalate quality or compliance issues as required.
• Support the maintenance and continuous improvement of quality systems processes, identifying opportunities to strengthen controls and efficiency.
• Work directly with operating entities and internal stakeholders to ensure timely completion and effective follow-up of change-related tasks.
• Participate in compliance audits as required, providing documentation, explanations, and support related to change control and quality systems.
• Maintain programs and processes that ensure high-quality products and compliance with current Good Manufacturing Practices (cGMP).
• Write and implement changes to controlled documents such as standard operating procedures (SOPs), specifications, and methods as needed.
• Provide guidance and technical knowledge to junior staff, monitor the performance of daily tasks, and support their development in quality systems and change control.

Essential Skills:

• Minimum of six years of experience in change control within a GxP environment.
• 6+ years of relevant experience in a GMP environment for biologics manufacturing with demonstrated change control experience.
• Strong background in quality assurance and document control in regulated manufacturing settings.
• Hands-on experience managing change control processes for manufacturing products, processes, equipment, facilities, and computerized systems.
• Proficiency in generating, analyzing, and trending quality system metrics to support management reviews.
• Ability to facilitate cross-functional meetings and navigate complex change review discussions to reach aligned decisions.
• Experience writing, revising, and implementing controlled documents such as SOPs, specifications, and methods.
• Technical sciences degree (BS or BA) from a scientific or technical discipline.
• Demonstrated understanding of cGMP requirements and GxP operations in biologics manufacturing.

Additional Skills & Qualifications:

• Experience with both small molecule and large molecule products, with a strong preference for biologics.
• Proven ability to work collaboratively with cross-functional teams and internal stakeholders.
• Strong attention to detail and commitment to thorough documentation and record-keeping.
• Ability to interpret and apply quality management system expectations and regulatory requirements to practical operations.
• Effective communication skills for leading discussions, presenting metrics, and supporting audits.
• Capability to provide mentorship and technical guidance to junior staff in quality systems and change control.

Work Environment:

This role operates in a regulated GMP biologics manufacturing environment that emphasizes quality, compliance, and continuous improvement. The Quality Systems Specialist works closely with manufacturing, quality, and other functional teams, frequently engaging in cross-functional meetings and audit activities. The position involves extensive use of computerized quality systems, change control tools, and document management platforms, as well as interaction with tracking databases for metrics and trending. Work is typically performed during standard business hours, with flexibility as needed to support audits, critical change activities, and management reviews. The environment is professional and structured, with clear procedures, controlled documentation, and established quality management system processes guiding daily work.

Job Type & Location:

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

Pay and Benefits:

The pay range for this position is $45.00 - $65.00/hr. Individual compensation offered for this position within this range will depend on many factors, including qualifications, skills, relevant experience, job knowledge, geographic location, internal equity, and other pertinent job-related factors. 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)

Application Deadline:

This position is anticipated to close on Nov 4, 2026.

Workplace Type:

This is a hybrid position in Foster City, CA.