GMP Deviation Investigator & CAPA Writer

System One; Lincolnton (NC); On-site; USD 45,000 - 65,000; Part time

Job summary

System One is seeking a Technical Investigation Writer for a contract position in Lincolnton, NC. You will investigate quality deviations across manufacturing and packaging operations, review GMP documents, and collaborate with Technical Services, Engineering and QA teams to determine root causes and CAPA actions.

The ideal candidate holds a Bachelor's degree in a scientific field, 3–5 years’ experience in regulated environments, and proven experience documenting deviations, investigations, and

Qualifications

• Bachelor’s degree in Pharmacy, Chemistry, Biochemistry, Life Sciences, or related science.
• 3–5 years in GMP-regulated pharma/biotech/manufacturing.
• Proven experience conducting and documenting deviations, non-conformances, and quality investigations.
• Experience authoring investigation reports, CAPAs, SOPs, batch records, and GMP docs.
• Experience in Manufacturing, Packaging, QA, Quality Systems, or Technical Services.
• Strong knowledge of cGMP, FDA regulations, and industry standards.
• Understanding of QMS including deviations, investigations, change controls, CAPAs, audits.
• Familiarity with risk assessment methodologies and quality compliance.
• Demonstrated expertise in investigations of manufacturing and packaging deviations.

Responsibilities

• Investigate quality deviations observed during raw material dispensing / manufacturing / packaging operations.
• Review GMP documents such as SOPs, Batch records, Logbooks to identify root cause using Kepner-Tregoe, Ishikawa, Fishbone, 5 Why.
• Partner with Technical Services, Engineering and Manufacturing to determine scope, impact and risk.
• Work with QA Compliance to finalize investigation reports and CAPAs timely.
• Ensure timely implementation of CAPA from deviations, customer complaints, internal audits.
• Monitor and ensure closure of all open deviations/non-conformances and CAPAs within timeframes.
• Review deviation trends to propose actions to prevent recurrence.
• Review and revise GMP documents (SOPs/Work Instructions/Production Records).

Skills

Deviation investigations

Quality investigations

GMP knowledge

Regulatory compliance

Education

Bachelor’s degree in Pharmacy

Tools

SOPs

Batch records

CAPA processes

Job description

System One is seeking a Technical Investigation Writer for a contract position in Lincolnton, NC. You will investigate quality deviations across manufacturing and packaging operations, review GMP documents, and collaborate with Technical Services, Engineering and QA teams to determine root causes and CAPA actions.

The ideal candidate holds a Bachelor's degree in a scientific field, 3–5 years’ experience in regulated environments, and proven experience documenting deviations, investigations, and