Technical Investigation 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

Job Title: Technical Investigation Writer

Location: Lincolnton, NC

Type: Contract

Compensation: up to $40.00 per hour

Work Model: ONSITE

Hours: 40 hours M-F

Responsibilities

• Investigate the quality deviations observed during raw material dispensing / manufacturing / packaging operations.

• Review GMP documents such as SOPs, Batch records, Logbooks to identify the root cause for the reported deviation using Kepner-Tregoe, Ishikawa, Fish bone, 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 department.

• Work with QA Compliance team members to finalize investigation reports and identify necessary CAPA for the reported deviation/non-conformance in timely manner.

• Ensure timely implementation of CAPA resulting from deviations, customer complaints, Internal Audits.

• Monitor and ensure closure of all open deviations/non-conformances and CAPAs within defined timeframes.

• Review deviation trend to determine and propose appropriate actions needed to prevent reoccurrence of similar events.

• Review and revise GMP documents (SOPs/Work Instructions/Productions 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.

System One, and its subsidiaries including Joulé and Mountain Ltd., are leaders in delivering outsourced services and workforce solutions across North America. We help clients get work done more efficiently and economically, without compromising quality. System One not only serves as a valued partner for our clients, but we offer eligible employees health and welfare benefits coverage options including medical, dental, vision, spending accounts, life insurance, voluntary plans, as well as participation in a 401(k) plan.

System One is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, age, national origin, disability, family care or medical leave status, genetic information, veteran status, marital status, or any other characteristic protected by applicable federal, state, or local law.

M3

Ref: #558-Scientific

System One, and its subsidiaries including Joulé, ALTA IT Services, CM Access, TPGS, and MOUNTAIN, LTD., are leaders in delivering workforce solutions and integrated services across North America. We help clients get work done more efficiently and economically, without compromising quality. System One not only serves as a valued partner for our clients, but we offer eligible full-time employees health and welfare benefits coverage options including medical, dental, vision, spending accounts, life insurance, voluntary plans, as well as participation in a 401(k) plan.

System One is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, age, national origin, disability, family care or medical leave status, genetic information, veteran status, marital status, or any other characteristic protected by applicable federal, state, or local law.