Job Description
We are looking for a Compliance Specialist - Technical Writer who will play a crucial role in writing and completing investigations and deviations from a compliance and operations standpoint. The ideal candidate will conduct root cause analysis, manage the full life cycle of investigations, and engage in technical writing. This role requires strong communication skills as it involves interviewing manufacturing personnel and speaking with vendors on investigations.
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.Benchmark industry standards to develop, advocate, and implement investigative and impact assessment tool sets.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 approach.Develop materials to train and educate personnel on writing problem statements and use of root cause analysis tools, discrepancy, and deviation process.Champion CAPA plans and implementation.Provide communication plan for ongoing deviations and CAPAs.Effectively create and communicate CAPA plan to responsible parties.Oversee timely completion of deviations, CAPAs, and Change Controls as necessary.Perform responsibilities such as BET testing, Suitability Testing, Water/Bioburden Testing, writing deviations/Lab Events, updating SOPs, and working on CAPAs and Change Controls.Essential Skills2-3 years of experience writing and reviewing deviations and investigations.2-3 years of previous experience working within a pharmaceutical company supporting manufacturing.Experience working within a quality assurance team.Excellent writing and editing skills for compliance documentation.Strong background in manufacturing processes.Bachelor's degree in a related scientific field.Experience in GMP Operations and/or Quality Assurance in Cell Therapies, Biotechnology, or Bio-Pharma.Root cause analysis experience in pharmaceutical or FDA-regulated operations.Experience using e-Quality Management Systems.Relevant IT skills, including proficiency with Visio, Microsoft Project, and Excel.Additional Skills & QualificationsExperience with CAPA and GMP.Previous experience with cell and gene or biologics.Technical writing expertise.Experience in opening and closing investigations.Experience with life cycle management.Strong knowledge of technical aspects, including equipment troubleshooting.Work Environment
The work environment offers significant growth opportunities as the company is expanding. We have a good work culture focused on saving patients' lives, providing a fulfilling and impactful work experience.
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 Feb 15, 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.
Diversity, Equity & InclusionAt Actalent, diversity and inclusion are a bridge towards the equity and success of our people. DE&I are embedded into our culture through:
Hiring diverse talent Maintaining an inclusive environment through persistent self-reflection Building a culture of care, engagement, and recognition with clear outcomes Ensuring growth opportunities for our peopleThe 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 process due to a disability, please email actalentaccommodation@actalentservices.com for other accommodation options.