Actalent is hiring: Technical Writer Compliance- QCM in Parsippany

Job Title: Technical Writer Compliance - QCMJob Description

We are seeking a dedicated Technical Writer with a focus on Compliance to manage and complete investigations and deviations from both compliance and operational perspectives. This role involves reviewing investigations for manufacturing and GMP compliance, conducting root cause analyses, and managing the full lifecycle of investigations independently. The candidate will engage with manufacturing personnel and vendors to gather information, requiring strong communication skills.

Responsibilities

• Determine the causes and preventative actions for Deviations, Non-Conformances, OOS, OOT, field complaints, and environmental excursion investigations.
• Drive investigations to the 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.
• Utilize change management approaches effectively.
• Develop materials to train and educate personnel on writing problem statements and the use of root cause analysis tools.
• Champion CAPA plans and their implementation.
• Provide a communication plan for ongoing deviations and CAPAs.
• Effectively create and communicate CAPA plans to responsible parties.
• Oversee the timely completion of deviations, CAPAs, and Change Controls as necessary.
• Maintain adherence to quality standards.

Essential Skills

• 3-5 years of experience writing and reviewing deviations and investigations.
• 3-5 years of previous experience in a pharmaceutical company supporting manufacturing.
• Previous experience within a quality assurance team.
• Strong technical writing and reporting skills.
• Experience in compliance, aseptic techniques, root cause analysis, and CAPAs.
• Bachelor's degree in a related scientific field.

Additional Skills & Qualifications

• Experience in GMP operations and/or Quality Assurance in Cell Therapies, Biotechnology, or Bio-Pharma.
• Experience using e-Quality Management Systems.
• Relevant IT skills, such as proficiency in Visio, Microsoft Project, and Excel.
• Previous experience with cell and gene or biologics.

Work Environment

Join a growing company with a positive work culture that focuses on saving patients' lives. The role offers exposure to new technical writing techniques and involves working with cross-functional departments daily. The opportunity provides growth and development within the company, which reports directly to the VP.

Job Type & Location

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

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 Sep 17, 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.