QA Auditor/Sr. Auditor

Organization: 
Regeneron
Job Location: 
Rensselaer, NY
Job Description: 

If you are looking for an uncommon opportunity -- a chance to join an organization known for its scientific excellence in the research and development of pharmaceuticals -- it's time to consider Regeneron.

Regeneron is a fully integrated biopharmaceutical company that discovers, invents, develops, manufactures, and commercializes medicines for the treatment of serious medical conditions. Regeneron markets three products in the United States, EYLEA® (aflibercept) Injection, ZALTRAP® (ziv-aflibercept) Injection for Intravenous Infusion, and ARCALYST® (rilonacept) Injection for Subcutaneous Use; ZALTRAP is co-commercialized with Sanofi. Phase 3 studies are in progress with EYLEA in two additional indications and with product candidates sarilumab and REGN727. Regeneron has active research and development programs in many disease areas, including ophthalmology, inflammation, cancer, and hypercholesterolemia.

Regeneron is currently seeking a talented and motivated QA Auditor (GMP )to join our Quality Assurance Department reporting to the Associate Manager Quality Auditing. This position will require experience in planning and conducting quality audits in manufacturing (GMP) within designated Quality Auditing area.

Essential Duties and Responsibilities include, but are not limited to, the following:
- May schedule, prepare and conduct audits in support of GMP as directed.
- May assemble and coordinate the activities of the audit team.
- Conducts audits in accordance with Regeneron standard operating procedures and quality policies.
- Interprets policies, standards, and regulations, and evaluates potentially critical problems not covered by policies, standards, and regulations.
- Exercises judgment in ensuring that written procedures are followed and in evaluating quality systems, processes, procedures, and protocols for compliance.
- Appropriately escalate any compliance issues.
- Communicates audit results to management and auditees through written audit reports.
- May manage post-audit activities and follow-up on any necessary corrective and preventive actions; resolves any conflicts.
- May assemble and coordinate the activities of the audit team.
- May assist with hosting regulatory facility inspections by acting as a scribe and/or document reviewer.
- May draft and issue periodic reports to site management as requested.
- May assist with training/orientation of new Quality Auditing staff.
- Ability to travel 40-70% of time as needed (travel may be domestic and international).

Knowledge and Specialized Skills:
- Good working knowledge of the technical concepts required for GMP Auditing;
- Knowledge of FDA, EMeA and other international Quality System rules and regulations is required.
- Knowledge of pharmaceutical/biotechnology process and auditing standards.
- Working knowledge of word processing, spreadsheet, and database management software
- Excellent oral, written, & interpersonal communication skills required
- Ability to communicate effectively and successfully manage conflict.
- Ability to interpret applicable standards and objectively make decisions.

Education and Experience:
Ideal candidate will have BS/BA with 5+ years of direct GMP audit experience in Biotech/Pharmaceutical industry.

We offer a competitive compensation and benefits package including stock incentives, 401k with company match as well as the expected health and welfare benefits. Comprehensive relocation benefits are available, as required.

This is an opportunity to join our select team that is already leading the way in the Pharmaceutical/Biotech industry. Apply to us today and find out what we mean when we say that, at Regeneron, we have an unwavering commitment to combining good science & good business.

EOE/M/F/D/V

Disclaimer:
Regeneron is not accepting unsolicited assistance from search firms/employment agencies for this employment opportunity. Please, no phone calls or emails to any employee of Regeneron about this opening. All resumes submitted by search firms/employment agencies to any employee at Regeneron via-email, the Internet or in any form and/or method without a valid written search firm agreement in place for this position will be deemed the sole property of Regeneron. No fee will be paid in the event the candidate is hired by Regeneron as a result of the referral or through other means. Moving forward, Regeneron is using the agency management company, Candex - www.candex.com

ARCALYST, EYLEA, and ZALTRAP are trademarks of Regeneron Pharmaceuticals, Inc.

To apply for this position, please CLICK HERE