CAPA Specialist

Job Title:

CAPA Specialist

Job Description

The CAPA Closure Specialist is tasked with ensuring the effective closure of Corrective and Preventive Actions (CAPAs) related to deviations, investigations, and non-conformances within pharmaceutical packaging and aseptic filling operations. This role is crucial in maintaining compliance with current Good Manufacturing Practices (cGMP), regulatory requirements, and internal quality systems. The position demands strong cross-functional collaboration with teams from Quality Assurance (QA), Manufacturing, Engineering, and Technical Writing to guarantee timely, compliant, and sustainable CAPA resolution in 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.

+ 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 (Track Wise, Veeva, etc.).

+ Technical writing or documentation experience (SOPs, batch records).

Work Environment

This is a 6-month on-site contract position located in Wilson, NC, with regular working hours from 8 AM to 5 PM, offering flexibility to accommodate earlier or later schedules. 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.

Final date to receive applications

This…