Technical Writer

The Technical Writer leads and authors thorough investigations of deviations within pharmaceutical manufacturing processes, including formulation, filling, and packaging. This role ensures compliance with cGMP regulations by identifying root causes, driving effective corrective and preventive actions (CAPAs), and supporting continuous improvement initiatives across the organization. The position offers the opportunity to work in a growing company with multiple new products and an exciting pipeline.

Responsibilities

• Lead end-to-end deviation investigations involving manufacturing operations such as aseptic and sterile filling, formulation and compounding, and packaging and inspection.
• Identify, document, and classify deviations from standard operating procedures (SOPs), batch records, and regulatory requirements.
• Perform structured root cause analysis (RCA) using tools such as 5 Whys and Fishbone (Ishikawa) diagrams, as well as other systematic problem-solving methods including 6M.
• Collaborate closely with cross-functional teams, including Manufacturing, Quality Assurance (QA), Quality Control (QC), and Engineering, to determine root causes and assess impact on product quality.
• Author clear, concise, and compliant investigation reports in accordance with cGMP and Good Documentation Practices (GDP).
• Document all investigation findings, data analyses, risk assessments, and conclusions in an accurate and audit-ready manner.
• Ensure timely closure of deviations with complete, compliant, and inspection-ready documentation.
• Maintain and update investigation records within electronic Quality Management Systems (eQMS), such as TrackWise, Veeva, or ETQ.
• Develop and implement effective Corrective and Preventive Actions (CAPAs) to address root causes and prevent recurrence of deviations.
• Partner with site stakeholders to track CAPA progress, verify CAPA effectiveness, and ensure timely completion.
• Support CAPA trending and contribute to continuous improvement initiatives across manufacturing operations.
• Investigate deviations occurring on the manufacturing floor by interfacing with floor personnel to understand real-time events and process conditions.
• Support batch record review and product disposition activities as needed to ensure product quality and compliance.
• Ensure that all investigations and related activities comply with cGMP, internal SOPs, and applicable regulatory expectations.
• Participate in internal and external audits and regulatory inspections by providing documentation and subject matter expertise on investigations and CAPAs.
• Analyze deviation and CAPA trends to identify opportunities for process optimization and quality improvement.
• Contribute to the revision of SOPs and related documentation based on investigation learnings and improvement initiatives.
• Support and, when appropriate, deliver training initiatives related to deviation management, root cause analysis, CAPA, and documentation best practices.

• Bachelor’s degree in Life Sciences, Chemistry, Engineering, or a related field.
• Experience working in a pharmaceutical, biotechnology, or other regulated manufacturing environment.
• Previous experience working on the pharmaceutical manufacturing floor under GMP conditions.
• At least 2 years of technical writing experience focused on investigations related to manufacturing processes such as filling, formulation, and packaging.
• Strong experience conducting deviation investigations in a regulated manufacturing setting.
• Proven expertise in root cause analysis (RCA) using systematic problem-solving tools such as 5 Whys, 6M, and Fishbone (Ishikawa) diagrams.
• Demonstrated experience with CAPA management, including development, implementation, and follow-up on effectiveness.
• Excellent technical writing and documentation skills, with the ability to produce clear, concise, and compliant investigation reports.
• Solid knowledge of current Good Manufacturing Practices (cGMP), Good Documentation Practices (GDP), and relevant regulatory requirements.

• Experience with aseptic or sterile manufacturing, filling operations, or biologics production.
• Familiarity with electronic quality systems such as TrackWise, Veeva, SAP, or ETQ.
• Six Sigma or Lean certification, or formal training in root cause analysis methodologies.
• Experience supporting internal or external audits and regulatory inspections.
• Six Sigma qualification noted as a strong asset.
• Ability to collaborate effectively with cross-functional teams and manufacturing floor personnel.
• Strong analytical, critical thinking, and problem-solving skills with a focus on continuous improvement.
• High attention to detail and strong organizational skills to manage multiple investigations and deadlines.

This is an on-site role based in Wilson, North Carolina. The position follows Monday through Friday standard business hours, with some flexibility to align with swing shift activities as needed to support manufacturing operations. Work takes place in a regulated pharmaceutical manufacturing environment that adheres to cGMP and GDP standards, with frequent interaction with manufacturing, QA, QC, and Engineering teams and regular use of electronic Quality Management Systems such as TrackWise, Veeva, SAP, or ETQ. The site is part of a growing operation with multiple new products and an exciting pipeline, offering a dynamic setting focused on continuous improvement and operational excellence.

Job Type & Location

This is a Contract position based out of Wilson, NC.

The pay range for this position is $45.00 - $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)

This is a fully onsite position in Wilson,NC.

This position is anticipated to close on Jun 30, 2026.

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 20,000 consultants and 5,000 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500. We are proud to be an Engineering News-Record (ENR) Top 500 Design Firm for our engineering design services and a ClearlyRated Best of Staffing® winner for both client and talent service.

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 actalentaccommodation@actalentservices.com for other accommodation options.

San Francisco Fair Chance Ordinance: Pursuant to the San Francisco Fair Chance Ordinance, for all positions located in the city and county of San Francisco, we will consider for employment qualified applicants with arrest and conviction records.

Massachusetts Lie Detector: It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.

Use of Artificial Intelligence (AI): We may use Artificial Intelligence (AI) to support parts of our hiring process, including sourcing, screening, and evaluating candidates. AI helps assess applications and qualifications, but final decisions are made by our hiring team. By applying, you acknowledge and agree that your application may be reviewed using AI tools.

Salary : $45 - $50