Job Description

Job Description

Job Description

Job Title: Technical Writer – Compliance

Location: Parsippany, NJ

Employment Type: 12-Month Contract

Industry: Pharmaceuticals / Biotechnology

We are seeking a detail-oriented and experienced Technical Writer – Compliance to join our Quality or Manufacturing team. In this role, you will be responsible for authoring, reviewing, and managing investigations and deviations from both compliance and operational perspectives. You will play a key role in ensuring adherence to GMP standards, driving root cause analysis, and supporting continuous improvement initiatives across manufacturing operations.

This position requires strong technical writing skills, a solid understanding of GMP regulations, and the ability to collaborate effectively with cross-functional teams, including manufacturing personnel and external vendors.

• Lead and author investigations for Deviations, Non-Conformances, OOS/OOT results, field complaints, and environmental excursions.
• Conduct thorough root cause analyses using industry-standard tools and methodologies.
• Develop and implement effective Corrective and Preventive Actions (CAPAs) to prevent recurrence.
• Manage multiple investigations simultaneously, ensuring timely closure in alignment with compliance deadlines and product release schedules.
• Collaborate with cross-functional teams to develop, track, and communicate CAPA plans.
• Identify trends and establish rules to proactively trigger corrective actions.
• Analyze process data to identify opportunities for operational and quality improvements.
• Apply change management principles to support continuous improvement.
• Create and deliver training materials on investigation writing and root cause analysis techniques.
• Serve as a CAPA champion, ensuring timely and effective implementation.
• Maintain clear communication with stakeholders regarding ongoing investigations and CAPAs.
• Ensure all documentation complies with internal quality standards and regulatory requirements.

• Bachelor’s degree in a scientific or technical discipline (e.g., Biology, Chemistry, Engineering).
• 3–5 years of experience writing and reviewing deviations, investigations, and CAPAs in a GMP-regulated environment.
• Proven experience supporting manufacturing operations in the pharmaceutical, biotechnology, or cell and gene therapy sectors.
• Strong knowledge of aseptic techniques and GMP compliance.
• Proficiency in root cause analysis tools (e.g., 5 Whys, Fishbone, FMEA).
• Excellent technical writing and communication skills.
• Experience working with e-Quality Management Systems (eQMS).

• Prior experience in Quality Assurance or Compliance roles.
• Familiarity with FDA-regulated operations and regulatory expectations.
• Experience with biologics, cell and gene therapies, or advanced therapy medicinal products (ATMPs).
• Proficiency with Microsoft Office Suite, including Excel, Visio, and Project.

• Be part of a mission-driven organization advancing life-saving therapies.
• Collaborate with a passionate and innovative team.
• Opportunity to grow your career in a cutting-edge, fast-paced environment.

Pay and Benefits

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)

Workplace Type

This is a fully onsite position in Parsippany,NJ.

Application Deadline

This position is anticipated to close on Jul 29, 2025.

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.

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