QA Validation Specialist - East Greenbush, United States - Regeneron Pharmaceuticals Inc.

Regeneron Pharmaceuticals Inc.

Verified Company

East Greenbush, United States

3 weeks ago

Posted by:

Mark Lane

beBee recruiter

Description

The QA Validation department is hiring This team supports validation of equipment, utilities, software, cleaning and sterilization processes at Regeneron's Rensselaer facility in accordance with regulatory requirements implementing company manufacturing standard policies and procedures.

In this role, a typical day may include:

Generates, executes and/or reviews master and completed qualification and validation protocols, summary reports and associated data for conformance to regulations, SOPs, specifications and other applicable acceptance criteria.

Analyzes the results of testing and determines the acceptability of results against pre-determined criteria.

Investigation and troubleshooting problems which occur during validations and determines solutions or recommendation for changes and/or improvements.

Coordinates with functional department to resolve issues from validations.

Reviews, edits and approves deviation notifications, deviation investigations and corrective actions.

Coordinates with other departments or outside contractors/vendors to complete validation tasks.

Develop tracking mechanism of validation activity completion for various projects and prepare status report.

Present validation project and program status reports to senior management on a routine basis.

Ensures that validation status is maintained for equipment and software use in commercial and clinical manufacturing.

Train/advises less experienced Specialists.

May supervise, provide direction and assign work to Validation Specialists and/or contingent workers to meet goals and deadlines.

Stays current with industry trends, regulatory requirement updates and communicating to teams.

May present at both internal and external (regulatory) audits.

Perform other duties assigned by management.

This role may be a fit for you if:
Ability to maintain integrity and honesty at all times

Ability to work independently or as part of a team

Ability to communicate with transparency

Continuously drive to improve processes for improved performance

Demonstrate respectful behavior at all times

Basic working knowledge of Microsoft Suite (Word, Excel, Powerpoint)

Gathers and organizes information

Meets commitments on time

Follows directions; performs well-defined tasks

Effective time management skills

Seeks to identify continuous improvement needs
To be considered for this position, you must hold a BS/BA in Engineering, Chemistry, or Life Sciences and:

Associate

QA Validation Specialist:
0-2 years of relevant experience

QA Validation Specialist: 2+ years of relevant experience

Sr

QA Validation Specialist:
5+ years of relevant experience
May substitute proven experience for education requirement.

REGNQA

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.

The Company will also provide reasonable accommodation to the known disabilities or chronic illnesses of an otherwise qualified applicant for employment, unless the accommodation would impose undue hardship on the operation of the Company's business.

Salary Range (annually) $58, $124,300.00