Pharma Quality Investigator: Deviation & Root-Cause Analysis

Norwich Pharmaceuticals; City of Norwich (NY); On-site; USD 62,000 - 65,000; Full time

Job summary

Norwich Pharmaceuticals is seeking a Quality Investigator to support the site deviation investigation system, including acting as an author of all relevant Operations deviations, to ensure delivery against QA goals and plant objectives. The role reports to the Manager of Quality Operations.

Primary duties include supporting impacted departments with investigation processes, performing root cause analysis, and maintaining knowledge of quality systems and regulatory guidelines (FDA, EU, ICH).

Qualifications

• Associate or Bachelor of Science in Chemistry, Life Science, Engineering or combination of training, education, and experience that is equivalent.
• A minimum of 1 - 3 years pharmaceutical industry experience, including experience in Quality Assurance/Quality Control.
• Working knowledge of Microsoft Office applications is required.
• Excellent communication skills with colleagues, peers, and outside clients.
• Attention to detail and capable of working independently.

Responsibilities

• Support all impacted departments with investigation process.
• Perform root cause analysis utilizing tools, as appropriate.
• Strong knowledge of Quality systems.
• General knowledge of plant systems; Operations (Manufacturing & Packaging), Laboratory, Supply Chain, Facility, etc.
• Keep abreast of industry regulatory and cGMP trends. Stay informed of FDA, EU and ICH Guidelines.

Skills

Communication

Detail orientation

Quality systems knowledge

Education

Bachelor of Science in Chemistry or Life Science or Engineering

Associate degree equivalent

Tools

Microsoft Office

Job description

Norwich Pharmaceuticals is seeking a Quality Investigator to support the site deviation investigation system, including acting as an author of all relevant Operations deviations, to ensure delivery against QA goals and plant objectives. The role reports to the Manager of Quality Operations.

Primary duties include supporting impacted departments with investigation processes, performing root cause analysis, and maintaining knowledge of quality systems and regulatory guidelines (FDA, EU, ICH).