Job Title: Compliance Specialist- Technical WriterJob DescriptionWe are seeking a Compliance Specialist- Technical Writer to join our team. The role involves writing and completing investigations and deviations from a compliance and operations perspective. You will be responsible for reviewing investigations and deviations to ensure manufacturing and GMP compliance, conducting root cause analysis, and independently managing the full lifecycle of investigations. This position requires excellent technical writing and communication skills as you will be interviewing manufacturing personnel and speaking with vendors.Responsibilities
Determine 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 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 processes.
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.
Ensure adherence to quality standards.
Essential Skills
2-3 years of experience writing and reviewing deviations and investigations.
2-3 years of previous experience working within a pharmaceutical company supporting manufacturing.
Experience within a quality assurance team.
Strong writing and editing skills.
Knowledge of compliance documentation and manufacturing processes.
CAPA experience.
GMP knowledge.
Experience in biopharma/biotech, especially with cell and gene or biologics.
Technical writing proficiency.
Experience in opening and closing investigations.
Lifecycle management of investigations.
Root cause analysis experience.
Additional Skills & Qualifications
Bachelor's degree in a related scientific field.
Experience with quality assurance to ensure accurate tracking and documentation of investigations from an operations standpoint.
Experience in GMP Operations and/or Quality Assurance in Cell Therapies, Biotechnology or Bio-Pharma.
Experience using e-Quality Management Systems.
Relevant IT skills, including proficiency in Visio, Microsoft Project, and Excel.
Work EnvironmentThe company offers significant opportunities for growth and is expanding rapidly. Our work culture is supportive, and we are dedicated to saving patients' lives. Join us to be a part of a dynamic and meaningful industry.Pay and BenefitsThe 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 TypeThis is a fully onsite position in Parsippany,NJ.Application DeadlineThis position is anticipated to close on Feb 12, 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 & Inclusion At 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 people
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 process due to a disability, please email [email protected] (%[email protected]) for other accommodation options.