Job Description
We are seeking a Technical Writer Compliance expert to manage and complete investigations and deviations from a compliance and operations perspective. The role involves technical writing, conducting root cause analysis, and collaborating with cross-functional teams to ensure GMP compliance and effective communication with vendors and manufacturing personnel.
ResponsibilitiesDetermine the causes and preventative actions of 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 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 root cause analysis tools.Champion CAPA plans and implementation.Provide communication plans for ongoing deviations and CAPAs.Effectively communicate CAPA plans to responsible parties.Oversee timely completion of deviations, CAPAs, and Change Controls as necessary.Ensure adherence to quality standards.Essential Skills3-5 years of experience writing and reviewing deviations and investigations.3-5 years of experience within a pharmaceutical company supporting manufacturing.Experience within a quality assurance team.Proficiency in technical writing and root cause analysis.Experience in GMP Operations and/or Quality Assurance in Cell Therapies, Biotechnology, or Bio-Pharma.Ability to conduct and manage life-cycle investigations, including deviations and non-conformances.Additional Skills & QualificationsBachelor's degree in a related scientific field.Experience with cell and gene or biologics.Experience using e-Quality Management Systems preferred.Relevant IT skills, including proficiency with Visio, Microsoft Project, and Excel.Experience writing and reviewing investigations and deviations.Work Environment
Join a growing company with a positive work culture dedicated to saving patients' lives. The role offers exposure to new technical writing techniques and the opportunity to work with cross-functional departments daily. The company is expanding, providing ample opportunities for internal growth and development.
Job Type & Location
This is a Contract position based out of Parsippany, New Jersey.
This position is INTERVIEWING NEXT WEEK - If interested, please submit your updated resume along with your availability for a 5-minute call to kvespia @astoncarter.com
Pay and BenefitsThe 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 9, 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.