QA Compliance Specialist

Job Description

Job Description

Job Title: QA Compliance Investigator

Job Description

Join a dynamic team dedicated to improving processes and ensuring compliance in a growing organization. As an Investigator, you will be responsible for writing and completing investigations and deviations, ensuring compliance from both a compliance and operations perspective. You will conduct root cause analyses and manage the full lifecycle of investigations, from opening to closing, independently.

Responsibilities

• Write and complete investigations and deviations ensuring compliance with manufacturing and GMP standards.
• Conduct root cause analysis and own the entire lifecycle of investigations.
• Interview manufacturing personnel and communicate with vendors regarding investigations.
• Determine causes and preventative actions for Deviations, Non-Conformances, OOS, OOT, field complaints, and environmental excursion investigations.
• Drive investigations to true root cause using appropriate tools and benchmark industry standards.
• Define and implement effective preventative actions to prevent recurrence.
• Manage multiple investigations in different stages to meet compliance deadlines and product release dates.
• Collaborate with cross-functional teams to develop and track CAPA plans.
• Identify and create appropriate trending rules to trigger corrective actions.
• Analyze process data and evaluate trends to identify improvement opportunities.
• Utilize change management approaches effectively.
• Develop materials to train personnel on writing problem statements and using root cause analysis tools.
• Champion CAPA plans and their implementation.
• Provide communication plans for ongoing deviations and CAPAs.
• Oversee timely completion of deviations, CAPAs, and Change Controls.

Essential Skills

• 2-3 years of experience writing and reviewing deviations and investigations.
• Experience within a pharmaceutical company supporting manufacturing.
• Previous experience in a quality assurance team.
• Experience with CAPA, GMP, and biopharma/biotech environments.
• Proficiency in technical writing and root cause analysis.
• Ability to own and author deviations.

Additional Skills & Qualifications

• Bachelor's degree in a related scientific field.
• Experience in GMP Operations and/or Quality Assurance in Cell Therapies, Biotechnology, or Bio-Pharma.
• Preferred experience in pharmaceutical or FDA-regulated operations.
• Experience using e-Quality Management Systems preferred.
• Proficiency in IT skills such as Visio, Microsoft Project, and Excel.

Work Environment

• You will work closely with a team of QA/QC professionals and collaborate cross-functionally with the manufacturing team.
• The team currently consists of 2-3 other investigators.
• The role involves working at two sites that are a block away from each other.
• The position is first shift, Monday through Friday, with a start time of 8am or 9am.
• The company offers a supportive work culture focused on growth and expansion, with the mission of saving patients' lives.

This is a Contract to Hire position based out of Allendale, NJ.

The pay range for this position is $45.00 - $45.00/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)

This is a fully onsite position in Allendale,NJ.

This position is anticipated to close on Jul 13, 2026.

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 20,000 consultants and 5,000 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500. We are proud to be an Engineering News-Record (ENR) Top 500 Design Firm for our engineering design services and a ClearlyRated Best of Staffing® winner for both client and talent service.

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 process due to a disability, please email View email address on ziprecruiter.com for other accommodation options.

San Francisco Fair Chance Ordinance: Pursuant to the San Francisco Fair Chance Ordinance, for all positions located in the city and county of San Francisco, we will consider for employment qualified applicants with arrest and conviction records.

Massachusetts Lie Detector: It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.

Use of Artificial Intelligence (AI): We may use Artificial Intelligence (AI) to support parts of our hiring process, including sourcing, screening, and evaluating candidates. AI helps assess applications and qualifications, but final decisions are made by our hiring team. By applying, you acknowledge and agree that your application may be reviewed using AI tools.