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 specialist works closely with Quality Assurance, Manufacturing, Engineering, and Technical Writing teams to deliver timely, compliant, and sustainable CAPA resolutions that support safe and efficient operations. Responsibilities Lead and coordinate CAPA closure activities related to pharmaceutical packaging and aseptic filling operations. Ensure CAPAs are completed in alignment with defined timelines, internal quality standards, and applicable regulatory expectations. Verify the completion and effectiveness of corrective and preventive actions prior to CAPA closure. Conduct follow-up activities to confirm sustained resolution of identified root causes and prevent recurrence. Review deviation investigations tied to packaging and filling processes to ensure robust root cause determination and appropriate CAPA linkage. 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 provides a sound closure rationale. Review and update Standard Operating Procedures, 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 management systems such as TrackWise, Veeva, or MasterControl. Partner with Manufacturing teams to address process gaps in packaging and filling operations, including equipment operation, HMI usage, and inspection processes. Work with Quality Assurance to support batch record review, lot release readiness, and compliance verification activities related to CAPAs. Collaborate with Engineering on process improvements, equipment changes, or validation activities that arise from CAPAs. Perform CAPA effectiveness checks and conduct trend analysis to identify recurring issues and systemic risks. 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 by leveraging CAPA data and trends. Contribute to remediation activities related to CAPA and quality system enhancements as needed. Essential Skills Bachelor’s 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. Proven experience managing or closing CAPAs within a regulated cGMP and FDA environment. Strong understanding of deviation investigations, root cause analysis, and quality systems. Previous pharmaceutical GMP experience supporting manufacturing operations. Hands‑on experience with manufacturing processes, including filling and packaging. Demonstrated CAPA closure experience with a focus on effectiveness and sustainability. Working knowledge of CAPA remediation practices in a regulated environment. Ability to interpret and apply cGMP and regulatory requirements to day‑to‑day operations. Strong documentation and record‑keeping skills to maintain audit‑ready CAPA files. Additional Skills & Qualifications Experience with injectable or sterile drug product packaging and filling operations. Familiarity with validation activities, including Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ). Experience with change control processes and batch record review. Experience using electronic quality management systems such as TrackWise, Veeva, or similar platforms. Technical writing experience, including drafting and revising Standard Operating Procedures and batch records. Ability to perform structured root cause analysis using tools such as 5 Whys, Fishbone diagrams, and risk assessments. Exposure to continuous improvement methodologies such as Lean and Kaizen. Strong cross‑functional collaboration skills, with the ability to work effectively with Quality Assurance, Manufacturing, Engineering, and Technical Writing teams. Attention to detail and a systematic approach to problem solving in a cGMP environment. Work Environment This is an on‑site role based in a pharmaceutical manufacturing facility focused on packaging and aseptic filling operations. The position is offered as a 6‑month contract and operates primarily during standard business hours, typically 8:00 a.m. to 5:00 p.m., with some flexibility to start earlier or finish earlier based on operational needs. The work environment is highly regulated and follows current Good Manufacturing Practices and FDA requirements, with strict adherence to established procedures, documentation standards, and quality systems. The role involves regular use of electronic quality management systems such as TrackWise, Veeva, or MasterControl, as well as interaction with production equipment, human‑machine interfaces, and inspection processes within clean, controlled areas appropriate for pharmaceutical manufacturing. Job Type & Location Contract position based out of Wilson, NC. Pay And Benefits The pay range for this position is $50.00 – $55.00 per hour. Benefits 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) EEO Statement 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. Legal Notices 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. Application Deadline Position is anticipated to close on Jun 5, 2026. #J-18808-Ljbffr