Pinnaql · 18 hours ago
Investigation and CAPA Specialist
Greenville, SC
Contract
Onsite
Senior Level
5+ years expPinnaql is a trusted consulting partner to regulated life sciences companies, providing expertise across every stage of the product lifecycle. They are seeking experienced Investigation and CAPA Specialists to provide on-site support for deviation investigations, root cause analysis, and CAPA development within a regulated aseptic manufacturing environment.
Biotechnology
Responsibilities
Lead and support manufacturing-driven investigations from initiation through completion, in alignment with site procedures and cGMP expectations
Perform detailed reviews of manufacturing processes, batch records, and supporting data to support root cause determination
Conduct interviews with manufacturing, operations, and support personnel
Author clear, concise investigation documentation, including root cause analysis and recommended CAPAs, for Quality review and approval
Support development, tracking, and closure of CAPAs, including effectiveness checks as applicable
Support ongoing and new investigations while maintaining on-site presence in manufacturing areas as required
Interface effectively with Manufacturing, Engineering, Training, and Quality functions
Ensure investigation documentation is accurate, complete, and inspection-ready
Qualification
Required
Bachelor's degree in Engineering, Science, or a related technical discipline (or equivalent industry experience)
Minimum of 5 years of experience supporting investigations in pharmaceutical or biotechnology manufacturing
Demonstrated experience leading manufacturing or process investigations and authoring investigation reports
Strong technical writing skills and ability to clearly document complex investigations
Understanding of aseptic manufacturing processes and cGMP requirements
Experience gathering data, conducting interviews, and supporting root cause analysis
Ability to manage multiple active investigations concurrently
Preferred
Knowledge of gowning practices and aseptic monitoring controls
Company
Pinnaql
At Pinnaql we believe that different perspectives and backgrounds are what make a company flourish.
11-50 employees
H1B Sponsorship
Pinnaql has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2024 (1)
Funding
Current Stage
Early StageRecent News
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