Job Description
We are seeking a skilled Technical Writer Compliance professional who will be responsible for writing and completing investigations and deviations from both compliance and operations perspectives. The role involves reviewing investigations and deviations to ensure manufacturing and GMP compliance, conducting root cause analysis, and managing the entire lifecycle of an investigation independently. This position requires excellent technical writing skills and effective communication as you will be interviewing manufacturing personnel and speaking with vendors regarding investigations.
ResponsibilitiesDetermine 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 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 trending rules that trigger corrective actions.Analyze process data and evaluate trends to identify major improvement opportunities.Utilize change management approaches effectively.Develop training materials for personnel on writing problem statements and using root cause analysis tools.Champion CAPA plans and implementation.Provide communication plans for ongoing deviations and CAPAs.Create and communicate CAPA plans to responsible parties.Oversee timely completion of deviations, CAPAs, and Change Controls as necessary.Abide by quality standards.Essential SkillsCompliance expertiseAseptic technique knowledgeRoot cause analysis proficiencyStrong technical writing skillsExperience in writing deviations and CAPAs3-5 years of experience in writing and reviewing deviations and investigations3-5 years of experience in a pharma company supporting manufacturingPrevious quality assurance team experienceAdditional Skills & QualificationsBachelor's degree in a related scientific fieldExperience in GMP Operations or Quality Assurance in Cell Therapies, Biotechnology, or Bio-PharmaPreferred experience in pharmaceutical or FDA regulated operationsExperience using e-Quality Management SystemsProficiency with IT skills, including Visio, Microsoft Project, and ExcelCAPA experiencePrevious experience with cell and gene or biologicsWork Environment
Join a dynamic team with direct reporting to the VP, working daily with cross-functional departments. Experience exposure to new technical writing techniques within a growing company that values good work culture and is committed to saving patients' lives.
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 2, 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.