Quality Investigator

Summary

Quality Investigator

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.

The Quality Investigator reports to the Manager of Quality Operations.

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.

An Equal Opportunity Employer, including disability/vets.

Job Description

Quality Investigator

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.

The Quality Investigator reports to the Manager of Quality Operations.

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.

An Equal Opportunity Employer, including disability/vets.