Quality Release Specialist

SUMMARY OF POSITION

The Quality Releaser supports the release process, to ensure delivery against both plant and Quality Assurance (QA) goals and objectives.

ORGANIZATION STRUCTURE

The Quality Releaser reports to the Quality Assurance Laboratory Lead.

RESPONSIBILITIES

Primary responsibilities of this role include the following:

1. Commercial Release
   1. Perform Commercial release, including Raw Material, Package Component, Semi-Finished, and Finished Product, etc.
   2. Ensure all release requirements are met, including quality and schedule commitments.
   3. Scan, file, retrieve, and maintain organized batch records/documentation.
2. General knowledge of plant operations; Manufacturing, Packaging, Laboratory, Supply Chain, Facility, etc.
3. Keep abreast of industry regulatory and cGMP trends. Stay informed of FDA, EU and ICH Guidelines.
4. Additional duties as assigned.

QUALIFICATIONS

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

Has authority to review and comment on GMP documentation.

The anticipated starting salary is $62354.00 for this position. 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 9/16/2026 and remain open for at least 10 days. To apply, select the apply button and submit your application.

An Equal Opportunity Employer, including disability/vets