Note: The job is a remote job and is open to candidates in USA. Joulé is a leader in delivering outsourced services and workforce solutions across North America. They are seeking a Technical Investigation Writer to investigate quality deviations in manufacturing operations and collaborate with various teams to ensure compliance and timely resolution of issues.
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.)
Skills
- 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, vision, spending accounts, life insurance, voluntary plans
- Participation in a 401(k) plan
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