Technical Investigation Writer

Location: Lincolnton, NC • Contract • Onsite • 40 hours M-F • Up to $40.00 per hour

Responsibilities

• Investigate the quality deviations observed during raw material dispensing, manufacturing, and packaging operations.
• Review GMP documents such as SOPs, Batch records, and Logbooks to identify the root cause for the reported deviation using Kepner-Tregoe, Ishikawa, Fishbone, and 5 Why methods.
• Partner with Technical Services, Engineering, and Manufacturing team members to determine the scope, impact, and risk associated with the deviations/non-conformances observed in Manufacturing and Packaging departments.
• Work with QA Compliance team members to finalize investigation reports and identify necessary CAPA for the reported deviation/non-conformance in a timely manner.
• Ensure timely implementation of CAPA resulting from deviations, customer complaints, and Internal Audits.
• Monitor and ensure closure of all open deviations/non-conformances and CAPAs within defined timeframes.
• Review deviation trends to determine and propose appropriate actions needed to prevent reoccurrence of similar events.
• Review and revise GMP documents (SOPs, Work Instructions, Production Records, etc.).

Requirements

• Bachelor's degree in Pharmacy, Chemistry, Biochemistry, Chemical Engineering, Life Sciences, or a related scientific discipline.
• Minimum 3-5 years of experience in Pharmaceutical, Biotechnology, Medical Device, or other regulated GMP manufacturing environments.
• Proven experience conducting and documenting deviation, non-conformance, and quality investigations.
• Experience authoring and reviewing investigation reports, CAPAs, SOPs, batch records, and other GMP documentation.
• Experience working in Manufacturing, Packaging, Quality Assurance, Quality Systems, or Technical Services functions.
• Strong understanding of current Good Manufacturing Practices (cGMP), FDA regulations, and applicable industry standards.
• Working knowledge of manufacturing, packaging, and raw material dispensing operations.
• Understanding of Quality Management Systems (QMS), including deviations, investigations, change controls, CAPAs, and audit management.
• Familiarity with risk assessment methodologies and quality compliance requirements.
• Demonstrated expertise in conducting thorough investigations of manufacturing and packaging deviations.

Benefits

• Health and welfare benefits coverage options including medical, dental, and vision.
• Spending accounts.
• Life insurance and voluntary plans.
• Participation in a 401(k) plan.