Job Title: Technical Writer Compliance

Job Description

We are seeking a skilled Technical Writer Compliance professional to complete and review investigations and deviations from both compliance and operations perspectives. This role involves conducting root cause analysis and managing the full life cycle of investigations independently. You will be responsible for technical writing and conducting interviews with manufacturing personnel and vendors to gather necessary information for investigations.

Responsibilities

• 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 of the process 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, discrepancy, and deviation processes.
• Champion CAPA plans and implementation.
• Provide communication plans for ongoing deviations and CAPAs.
• Effectively create and communicate CAPA plans to responsible parties.
• Oversee timely completion of deviations, CAPAs, and Change Controls as necessary.
• Abide by quality standards.

Essential Skills

• 3-5 years of experience writing and reviewing deviations and investigations.
• 3-5 years of experience working within a pharmaceutical company supporting manufacturing.
• Previous experience within a quality assurance team.
• Proficient in technical writing and authoring deviations.
• Strong communication skills for interviewing and collaboration.

Additional Skills & Qualifications

• Bachelor's degree in a related scientific field.
• CAPA experience.
• GMP knowledge.
• Biopharma/biotech experience.
• Previous experience with cell and gene or biologics.
• Root cause analysis experience in pharmaceutical or FDA regulated operations preferred.
• Experience using e-Quality Management Systems preferred.
• Relevant IT skills, including proficiency in Visio, Microsoft Project, and Excel.

Work Environment

This position offers significant growth opportunities within a company that is expanding rapidly. You will be part of a team with a strong culture focused on saving patients' lives. You will work closely with cross-functional departments and have exposure to new technical writing techniques.

Pay and Benefits

The pay range for this position is $40.00 - $50.00/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 May 30, 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 : $40 - $50