Quality Investigator

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

Job summary

Regulatory Jobs is seeking a Quality Investigator to support site deviation investigations and author relevant Operations deviations to ensure QA goals are met. The role reports to the Manager of Quality Operations and collaborates across Manufacturing, Laboratory, and Supply Chain.

Responsibilities include investigating processes, performing root cause analysis, and maintaining knowledge of Quality systems while staying current with FDA, EU, and ICH guidelines.

Qualifications

• Associate or Bachelor of Science in Chemistry, Life Science, Engineering or equivalent.
• 1–3 years pharmaceutical industry experience, including QA/QC.
• Working knowledge of Microsoft Office applications.
• Excellent communication skills with colleagues, peers, and outside clients.
• Attention to detail and able to work independently.

Responsibilities

• Support all impacted departments with investigation process.
• Perform root cause analysis utilizing appropriate tools.
• Maintain strong knowledge of Quality systems.
• General knowledge of plant systems including Operations, Laboratory, Supply Chain, and Facilities.
• Stay informed of FDA, EU and ICH Guidelines.

Skills

Excellent communication

Attention to detail

Quality systems knowledge

Education

Associate or Bachelor of Science in Chemistry, Life Science, Engineering

Tools

Microsoft Office

Quality systems

Job description

SUMMARY OF POSITION

The Quality Investigator supports the site deviation investigation system, including acting as an author of all relevant Operations deviations, to ensure delivery against both plant and Quality Assurance (QA) goals and objectives.

ORGANIZATION STRUCTURE

The Quality Investigator reports to the Manager of Quality Operations.

RESPONSIBILITIES

Primary responsibilities of this role include the following:

Level I:

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

QUALIFICATIONS

Level I:

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

GMP DECISION-MAKING AUTHORITY

Level I:

Has authority to review and comment on GMP documentation.

The anticipated base salary range for this position is $62,354.00 -$65,000.00. This position is eligible for Alvogen’s annual discretionary bonus and comprehensive benefits package, consisting of medical and prescription drug coverage (two PPO plans and an HDHP with Health Savings Account and employer contribution), dental, vision, flexible spending accounts. Alvogen’s benefits package also includes a retirement savings program, long-term care coverage, paid time off (176 hours per year, prorated to hire date) inclusive of sick time, disability benefits, life insurance, a wellness program, and 13 company recognized paid holidays per year. We anticipate this position will be posted on 9/28/2026 and remain open for at least 30 days.

An Equal Opportunity Employer, including disability/vets.