Technical Writer Compliance

This role involves writing and completing investigations and deviations with a focus on compliance and operations. The individual will be responsible for reviewing investigations and deviations to ensure compliance with manufacturing and GMP standards. The role requires conducting root cause analysis and managing the full life cycle of investigations independently. The candidate will also engage in technical writing and interviewing manufacturing personnel for investigations, requiring strong communication skills. Additionally, interaction with vendors on investigations is expected.

• Determine the causes and preventative actions for Deviations, Non-Conformances, OOS, OOT, field complaints, and environmental excursion investigations.
• Drive investigations to true root cause using appropriate investigation tools and benchmark industry standards.
• Define and implement effective preventative actions to prevent recurrence.
• Manage multiple investigations in different stages to efficiently meet compliance deadlines and product release dates.
• Collaborate with cross-functional teams to develop and track CAPA plans.
• Identify and create appropriate trending rules that trigger corrective actions.
• Analyze process data and evaluate trends to identify major improvement opportunities.
• Effectively utilize change management approaches.
• Develop materials to train and educate personnel on writing problem statements and using root cause analysis tools.
• Champion CAPA plans and implementation.
• Provide communication plans for ongoing deviations and CAPA’s.
• Create and communicate CAPA plans to responsible parties.
• Oversee timely completion of deviations, CAPAs, and Change Controls.

• 3-5 years of experience writing and reviewing deviations and investigations.
• Experience within a pharma company supporting manufacturing.
• Previous experience within a quality assurance team.
• Strong technical writing and communication skills.
• Proficiency in root cause analysis.
• Experience in CAPA management.
• Familiarity with GMP, Biopharma/biotech, and cell and gene or biologics.

• Bachelor's degree in a related scientific field.
• Experience in GMP Operations and/or Quality Assurance in Cell Therapies, Biotechnology, or Bio-Pharma.
• Experience using e-Quality Management Systems.
• Relevant IT skills, including proficiency in Visio, Microsoft Project, and Excel.

The company is experiencing significant growth, offering a lot of internal growth opportunities. The work culture is positive, and the role contributes to saving patients' lives. The team reports directly to the VP and works with cross-functional departments daily, providing exposure to new technical writing techniques.

This is a Contract position based out of Parsippany, NJ.

The pay range for this position is $50.00 - $55.00/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 Parsippany,NJ.

This position is anticipated to close on Apr 7, 2026.

Diversity, Equity & Inclusion

At Actalent, diversity and inclusion are a bridge towards the equity and success of our people. DE&I is embedded into our culture through:

• Hiring diverse talent
• Maintaining an inclusive environment through persistent self-reflection
• Building a culture of care, engagement, and recognition with clear outcomes
• Ensuring growth opportunities for our people

Actalent is an equal opportunity employer.

About Actalent

Actalent is a global leader in engineering and sciences services. For more than 40 years, we’ve helped visionary companies advance their goals. Headquartered in the United States, our teams span 150 offices across North America, EMEA, and APAC—with four delivery centers in India led by 1,000+ extraordinary employees who connect their passion with purpose every day.

Our Bangalore, Hyderabad, Pune, and Chennai delivery centers are hubs of engineering expertise, with core capabilities in mechanical and electrical engineering, systems and software, and manufacturing engineering. Our teams deliver work across multiple industries including transportation, consumer and industrial products, and life sciences. We serve more than 4,500 clients, including many Fortune 500 brands. Learn more about how we can work together at actalentservices.com.