CAPA Specialist

Job Title: CAPA Specialist

Job Description

The CAPA Closure Specialist is tasked with driving the effective closure of Corrective and Preventive Actions (CAPAs) associated with deviations, investigations, and non-conformances within pharmaceutical packaging and aseptic filling operations. This role ensures compliance with current Good Manufacturing Practices (cGMP), regulatory requirements, and internal quality systems. The position requires strong cross-functional collaboration with Quality Assurance, Manufacturing, Engineering, and Technical Writing teams to ensure timely, compliant, and sustainable CAPA resolution within a highly regulated production environment.

Responsibilities

• Lead and coordinate CAPA closure activities related to packaging and filling operations.
• Ensure CAPAs are completed in alignment with defined timelines, quality standards, and regulatory expectations.
• Verify completion and effectiveness of corrective and preventive actions prior to closure.
• Conduct follow-ups to confirm sustained resolution of identified root causes.
• Review deviation investigations tied to packaging and filling processes.
• Support or perform root cause analysis using tools such as 5 Whys, Fishbone, or risk assessment methodologies.
• Ensure all documentation clearly supports CAPA effectiveness and closure rationale.
• Review and update Standard Operating Procedures (SOPs), batch records, and associated documentation as part of CAPA execution.
• Ensure all documentation meets cGMP, FDA, and internal quality system requirements.
• Maintain accurate and audit-ready CAPA records within electronic quality systems (e.g., TrackWise, Veeva, MasterControl).
• Partner with Manufacturing teams to address process gaps in packaging and filling operations.
• Work with QA to support batch record review, lot release readiness, and compliance verification.
• Collaborate with Engineering on process improvements, equipment changes, or validation activities related to CAPAs.
• Perform CAPA effectiveness checks and trend analysis to identify recurring issues.
• Recommend process improvements and preventive measures to reduce deviations and improve operational efficiency.
• Support continuous improvement initiatives such as Lean, Kaizen, or risk reduction programs.

Essential Skills

• Bachelor's degree in Life Sciences, Engineering, or related field.
• 3+ years of experience in pharmaceutical manufacturing, preferably in packaging or aseptic filling environments.
• Experience managing or closing CAPAs within a regulated (cGMP/FDA) environment.
• Strong understanding of deviation investigations, root cause analysis, and quality systems.

Additional Skills & Qualifications

• Experience with injectable or sterile drug product packaging/filling operations.
• Familiarity with validation (IQ/OQ/PQ), change control, and batch record review processes.
• Experience with electronic QMS systems (TrackWise, Veeva, etc.).
• Technical writing or documentation experience (SOPs, batch records).

Work Environment

This is a 6-month contract position located onsite in Wilson, NC. Normal work hours are from 8 AM to 5 PM with flexibility to start earlier or finish later. The environment is very fast-paced with over 500 CAPAs needing implementation.

Job Type & Location

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

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:

• 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 Wilson,NC.

Application Deadline

This position is anticipated to close on Jul 17, 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.