QA Validation Specialist (Cold Chain Qualification)

The QA Validation Department at Regeneron is adding to their team! We are currently looking to fill several QA Validation Specialists in areas including

This team works closely with our Drug Manufacturing and Packaging Engineers to make sure our products are handled securely and not affected in transportation; a background in thermal dynamics is preferred

This area also validates and qualifies equipment, systems, documentation and processes in accordance with regulatory requirements and support, follow and implement company manufacturing standards policies and procedures.

The day to day of a QA Validation Specialist could include, but are not limited to, the following:

Generating, implementing and/or reviewing master and completed qualification and validation protocols, summary reports and associated data for conformance to regulations, SOPs, specifications and other applicable acceptance criteria

Analyzing the results of testing and deciding the acceptability of results against pre-determined criteria

Investigating and troubleshooting problems which occur and determining solutions or recommendations for changes and/or improvements

Reviewing, editing and approving deviation notifications, deviation investigations, corrective actions, change controls, SOPs, reports and other documentation

This role might be for you if you:

Have validation or engineering experience in the pharmaceutical industry or similar industries

Can coordinate with other departments or outside contractors/vendors to complete validation tasks

Continuously seek to improve processes for improved performance

Have hands on execution of validation studies

To be considered for this role you must hold a Bachelors degree in Engineering, Chemistry, or Life Sciences and the following years of relevant experience for each level:

Assoc. QA Validation Specialist : 0 2 years

QA Validation Specialist: 2+ years

May substitute proven experience for education requirement.

Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, nationality, national or ethnic origin, civil status, age, citizenship status, membership of the Traveler community, sexual orientation, disability, genetic information, familial status, marital or registered civil partnership status, pregnancy or parental status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations. We will ensure that individuals with disabilities are provided reasonable accommodations to participate in the job application process. Please contact us to discuss any accommodations you think you may need.

The salary ranges provided are shown in accordance with U.S. law and apply to U.S. based positions, where the hired candidate will be located in the U.S. If you are outside the U.S, please speak with your recruiter about salaries and benefits in your location.

Salary Range (annually) $58,480.40 - $106,300.00

Permanent