Deviations Investigator

Insight Global; North Carolina; Vor Ort; USD 57.859 - 67.502; Teilzeit

Benefits dieser Stelle

Medical insurance

Vision insurance

401(k)

Zusammenfassung

A leading recruitment and staffing agency is seeking a Deviation Investigator for a contract position in the Raleigh-Durham area. The role involves conducting thorough investigations of deviations, performing root cause analysis, and developing action plans to prevent recurrence. Candidates must have a Bachelor's degree and relevant experience in pharmaceutical or biotechnology industries. Key benefits include medical and vision insurance and a 401(k).

Qualifikationen

• 3-5 years of experience in deviations investigations in pharmaceutical or biotechnology industries.
• Ability to reach and interpret documents such as safety rules and procedure manuals.
• Proven experience writing routine reports and correspondence.

Aufgaben

• Conduct deviation investigations, perform root cause analysis, and develop Corrective and Preventative Actions.
• Initiate CAPA quality records and follow-up on the implementation of actions.
• Analyze deviation trends to aid in Risk Assessment and develop appropriate Preventive Actions.
• Support change controls, training, and inspection preparation activities.

Kenntnisse

Deviation investigations experience

Strong communication skills

Ability to analyze trends

Ausbildung

Bachelor's Degree in related field

Jobbeschreibung

This range is provided by Insight Global. Your actual pay will be based on your skills and experience — talk with your recruiter to learn more.

Base pay range

$42.00/hr - $49.00/hr

Must Haves

• Bachelor's Degree in related field
• 3-5 years of experience in deviations investigations in pharmaceutical or biotechnology industries
• Ability to reach and interpret documents such as: safety rules, operating and maintenance instructions, procedure manuals, test methods, and SOPs
• Proven experience writing routine reports and correspondence

Job Description

Insight Global is seeking a Deviation Investigator for a large biopharmaceutical client in the Raleigh-Durham area. The investigator will independently conduct efficient and thorough investigations of deviations that occur in Manufacturing (or related areas, Supply Chain, IT), perform root cause analysis and contribute to developing appropriate Corrective and Preventative Actions designed to adequately address and correct the deficiencies identified during the investigation process. The investigator will complete the investigations and CAPAs in alignment with established procedures and timelines.

Responsibilities

• Write and conduct quality control deviation investigations, including interviews and discussions with technical SMEs. Gather information from all necessary internal and external sources to evaluate the impact of the deviation to the product as well as the risk to future operations. Perform root cause and historical trend analysis and develop appropriate Corrective and Preventative Action (CAPA) to prevent deviation recurrence.
• Initiate CAPA quality records, execute the process and follow-up on the implementation of the actions. Act as an area/department representative in deviation discussions, coordinating activity and proposals with functional area approvers for both deviations and CAPAs.
• Analyze deviation trends within Manufacturing department to aid into Risk Assessment and development of appropriate Preventive Actions in support of continuous improvement.
• Support change controls, training, inspection preparation activities.

Seniority level

Mid-Senior level

Employment type

Contract

Job function

Writing/Editing and Quality Assurance

Industries

Pharmaceutical Manufacturing

Benefits

• Medical insurance
• Vision insurance
• 401(k)