Job Title: Quality Systems Specialist

Job Description

Join our dynamic team to support the implementation and training of Veeva electronic systems while ensuring compliance with quality objectives and regulatory requirements.

Responsibilities

• Provide on-floor Quality Operations support for manufacturing, warehouse, and technical operations, including in-process checks and deviation identification.
• Ensure all manufacturing activities comply with GMP and regulatory requirements.
• Review and approve GMP documentation such as batch records, SOPs, test methods, validation protocols, and technical reports for accuracy and compliance.
• Execute product-related activities including material receipt, raw material disposition, production document issuance, batch review, and final product disposition and shipment.
• Ensure timely resolution and escalation of quality issues to support lot closure and product release.
• Support continuous improvement initiatives to enhance quality, compliance, and operational efficiency.
• Participate in and support internal audits, facility walkthroughs, and regulatory inspections.
• Proactively notify management of risks and help implement process improvements based on root cause trends and investigation outcomes.
• Perform additional duties as required to support departmental needs.

Essential Skills

• Bachelor’s degree in a relevant scientific discipline.
• 1 years of experience in Quality Management Systems (QMS) with Veeva, including system setup, testing execution, and implementation.
• 5 years of experience in the pharmaceutical or GMP industry, with 5-7 years of QA experience in a GMP-regulated environment.
• Strong knowledge of batch record review, aseptic operations, and environmental monitoring.
• Proficiency in cGMP regulations (21 CFR Parts 210, 211, 1271) and relevant ICH and FDA guidance.
• Demonstrated ability to lead and close complex quality investigations, including root cause analysis and development of effective CAPAs.
• Proficient in investigation tools and methodologies such as Fishbone diagrams, 5 Whys, and FMEA.

Additional Skills & Qualifications

• Experience with cell therapy, gene therapy, or other advanced biologics; CDMO experience strongly preferred.
• Ability to understand technical concepts and make informed quality decisions in clinical manufacturing.
• Willingness to work in ISO 7 environments for on-the-floor QA support.
• Strong problem-solving skills focused on risk-based decision-making and continuous improvement.
• Adaptable, proactive, and committed to continuous learning.
• Flexibility to travel between facilities and work varying hours, including evenings, weekends, and shifts as needed.
• Highly organized, team-oriented, and able to work independently.

Work Environment

Work at a brand new, growing CDMO site specializing in cell and gene therapy. The position involves hands-on quality oversight on the manufacturing floor, including ISO 7 gowning requirements. The role offers the opportunity to engage in technical conversations with product development and MSAT teams, ensuring operational excellence in a dynamic and innovative environment.

Job Type & Location

This is a Contract position based out of NA, New Jersey.

Pay and Benefits

The pay range for this position is $28.00 - $35.00/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 fully onsite position in Princeton,NJ.

Application Deadline

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

About Actalent

Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.

The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.

If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing due to a disability, please email actalentaccommodation@actalentservices.com for other accommodation options.

Salary : $28 - $35