Project Specialist

job summary:
The Project Administrator supports Technology Transfer and CAPEX projects by managing and coordinating Change Controls from initiation through closure. This role works closely with Project Managers and cross-functional teams to ensure changes are executed compliantly, approvals are obtained on schedule, and project deliverables are completed on time. The Project Administrator serves as a key driver of Change Control execution, timeline management, and team coordination within a GMP-regulated biopharmaceutical environment.

location: Vacaville, California
job type: Contract
salary: $44.00 - 46.50 per hour
work hours: 9 to 5
education: Bachelors

responsibilities:

Change Control Management

- Own and manage Change Controls supporting Technology Transfer projects.

- Drive Change Controls through the full lifecycle, ensuring timely completion of actions, approvals, and implementation activities.

- Monitor timelines, identify risks or delays, and escalate issues as needed.

- Coordinate with Quality, Manufacturing, Engineering, Validation, Regulatory, and Supply Chain teams to support successful change implementation.

Project Administration & Coordination

- Schedule and facilitate project meetings, document meeting minutes, and track action items to completion.

- Support Project Managers with project planning, status tracking, and cross-functional coordination.

- Maintain project documentation and provide regular updates on project and Change Control status.

- Assist with project reporting, milestone tracking, and stakeholder communications.

Compliance & Execution

- Ensure Change Controls and project documentation comply with site procedures and cGMP requirements.

- Maintain accurate, complete, and audit-ready records.

- Support inspection readiness and regulatory compliance activities.

- Drive accountability across stakeholder groups to meet project timelines and business objectives.

qualifications:

Education:

- Bachelor's degree in Life Sciences, Biotechnology, Engineering, Quality, Business, or a related discipline preferred.

Experience

- 2+ years of experience in biotechnology, pharmaceutical, medical device, or other GMP-regulated industries.

- Experience managing or coordinating Change Controls in a complex regulated environment.

- Experience with electronic Quality Management Systems (eQMS) and Change Control platforms such as Veeva, TrackWise, MasterControl, or similar systems is strongly preferred.

Core Competencies

- Strong understanding of Change Control processes and quality systems.

- Familiarity with cGMP requirements and regulated manufacturing environments.

- Excellent organizational, communication, and stakeholder management skills.

- Ability to manage multiple priorities and drive actions to completion across cross-functional teams.

- Strong attention to detail and ability to maintain compliant documentation.

Preferred Background

- Quality Assurance

- Compliance / Quality Systems

- Biotech or Pharmaceutical Manufacturing

- Engineering or Validation

- Technology Transfer Support

- Project Administration or Project Coordination

skills: Good Manufacturing Practices (GMP), Quality Management Systems (QMS)


Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.

At Randstad, we welcome people of all abilities and want to ensure that our hiring and interview process meets the needs of all applicants. If you require a reasonable accommodation to make your application or interview experience a great one, please contact View email address on randstadusa.com.


Pay offered to a successful candidate will be based on several factors including the candidate's education, work experience, work location, specific job duties, certifications, etc. In addition, Randstad offers a comprehensive benefits package, including: medical, prescription, dental, vision, AD&D, and life insurance offerings, short-term disability, and a 401K plan (all benefits are based on eligibility).


This posting is open for thirty (30) days.

Qualified applicants in San Francisco with criminal histories will be considered for employment in accordance with the San Francisco Fair Chance Ordinance.


Qualified applicants with arrest or conviction records will be considered for employment in accordance with the Los Angeles County Fair Chance Ordinance for Employers and the California Fair Chance Act.


We will consider for employment all qualified Applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles' Fair Chance Initiative for Hiring Ordinance.