Technical Writer - Compliance Job at Actalent in Lake Hiawatha

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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.

Job Title : Technical Writer Compliance

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.

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 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 Skills

Additional Skills & Qualifications

This position is urgently hiring. If interested, please submit your most updated resume and email your availability over for a 5-10 minute call to kvespia @astoncarter.com

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

Workplace Type

This is a fully onsite position in Parsippany,NJ.

Application Deadline

This position is anticipated to close on Jul 16, 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.

Seniority level

Seniority level

Mid-Senior level

Employment type

Employment type

Contract

Job function

Job function

Marketing, Public Relations, and Writing / Editing

Industries

Business Consulting and Services

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