CAPA Specialist

Job Title: CAPA Specialist Job Description
The CAPA Specialist is responsible for 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 that all activities comply with current Good Manufacturing Practices (cGMP), regulatory requirements, and internal quality systems, while supporting a highly regulated production environment. The position requires strong cross-functional collaboration with Quality Assurance, Manufacturing, Engineering, and Technical Writing teams to achieve timely, compliant, and sustainable CAPA resolution.
Responsibilities
- Lead and coordinate CAPA closure activities related to pharmaceutical packaging and aseptic 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 CAPA closure.
- Conduct follow-ups to confirm sustained resolution of identified root causes and prevent recurrence.
- Review deviation investigations tied to packaging and filling processes to ensure accurate root cause identification.
- Support or perform root cause analysis using tools such as 5 Whys, Fishbone diagrams, and risk assessment methodologies.
- Ensure all investigation and CAPA 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, complete, and audit-ready CAPA records within electronic quality systems such as TrackWise, Veeva, or MasterControl.
- Partner with Manufacturing teams to address process gaps in packaging and filling operations, including equipment operation, HMI use, and inspection processes.
- Work with Quality Assurance to support batch record review, lot release readiness, and compliance verification.
- Collaborate with Engineering on process improvements, equipment changes, and validation activities related to CAPAs.
- Perform CAPA effectiveness checks and trend analysis to identify recurring issues and systemic problems.
- Recommend process improvements and preventive measures to reduce deviations and enhance operational efficiency.
- Support continuous improvement initiatives such as Lean, Kaizen, and risk reduction programs.
- Contribute to remediation efforts and CAPA programs focused on resolving quality and compliance gaps.
- Engage in investigations related to customer complaints and deviations, ensuring appropriate CAPA actions are implemented.
Essential Skills
- Bachelors degree in Life Sciences, Engineering, or a related field.
- At least 3 years of experience in pharmaceutical manufacturing, preferably in packaging or aseptic filling environments.
- Demonstrated experience managing or closing CAPAs within a regulated cGMP/FDA environment.
- Strong understanding of deviation investigations, root cause analysis, and quality systems.
- Previous pharmaceutical GMP experience with filling and packaging operations.
- Hands-on CAPA closure experience, including verification of effectiveness and documentation of closure rationale.
- Experience with investigations, including customer complaints and deviation-related root cause analysis.
- Proficiency using electronic quality management systems, particularly TrackWise, and familiarity with other systems such as Veeva or MasterControl.
- Ability to review and update SOPs, batch records, and other technical documentation in a clear and compliant manner.
- Strong attention to detail and ability to maintain accurate, audit-ready records.
- Effective communication and collaboration skills for working with Quality Assurance, Manufacturing, Engineering, and Technical Writing teams.
Additional Skills & Qualifications
- Experience with injectable or sterile drug product packaging and filling operations.
- Familiarity with validation activities, including IQ, OQ, and PQ, and related change control processes.
- Experience with batch record review and support of lot release readiness.
- Technical writing or documentation experience, particularly in drafting and revising SOPs and batch records.
- Exposure to remediation projects focused on improving quality systems and closing large volumes of CAPAs.
- Experience supporting or participating in continuous improvement initiatives such as Lean, Kaizen, or risk reduction programs.
- Ability to perform risk assessments and contribute to risk-based decision making in a manufacturing environment.
Work Environment
This is an on-site, fast-paced role based in a pharmaceutical manufacturing facility with a strong focus on packaging and aseptic filling operations. The position is structured as a 6-month contract, with standard working hours typically from 8:00 a.m. to 5:00 p.m., and flexibility to start earlier or finish later as business needs require. The environment is highly regulated and quality-driven, with a significant volume of CAPAsover 500that need to be implemented and closed, offering substantial exposure to complex quality and manufacturing challenges. Work is performed within cGMP and FDA-regulated operations, utilizing electronic quality management systems such as TrackWise, Veeva, or MasterControl, and involves close collaboration with Quality Assurance, Manufacturing, Engineering, and Technical Writing teams in an on-site setting.
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. Individual compensation offered for this position within this range will depend on many factors, including qualifications, skills, relevant experience, job knowledge, geographic location, internal equity, and other pertinent job-related factors. 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 Sep 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
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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.

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