QC Compliance Specialist

Location
Rensselaer, New York
Posted
Apr 21, 2018
Ref
13169BR
Required Education
Bachelors Degree
Position Type
Full time
Position Summary

Known for its scientific and operational excellence, Regeneron is a leading science-based biopharmaceutical company that discovers, invents, develops, manufactures, and commercializes medicines for the treatment of serious medical conditions. Regeneron commercializes medicines for eye diseases, high LDL-cholesterol, atopic dermatitis and a rare inflammatory condition and has product candidates in development in other areas of high unmet medical need, including rheumatoid arthritis, asthma, pain, cancer and infectious diseases.

Summary: Assist Quality Control laboratories with investigations, deviations, method changes and document workflows as needed by specific functions including Chemistry, Bioassay, Microbiology and Virology.

Essential Duties and Responsibilities include, but are not limited to, the following:
• Ensure that all activities related to the investigation and resolutions of non-conformities are performed in a timely manner and in compliance with Regeneron procedures and regulatory requirements.
• Lead and participate directly in the investigation process.
• Write and/or review investigation reports.
• Contribute in cross-functional meetings to conduct root-cause analysis and determine corrective and preventative actions.
• Assist in the execution of Corrective & Preventative Actions and ensure they are appropriate, effective, and are implemented as planned in a timely manner.
• Identify recurring events and trends within Quality Control's deviations and propose continuous improvement ideas based on findings.
• Keeps team members informed of the status of assigned work.

Knowledge, Skills & Abilities:
• Requires excellent written, verbal and interpersonal communication skills and the ability to effectively interact with all levels to communicate negative information and obtain positive results.
• Ability to effectively interact with regulatory inspectors.
• Ability to resolve differing perspectives with effective negotiation and problem analysis skills.
• Ability to handle multiple projects and changing priorities with organizational and time management skills. Demonstrate a positive proactive approach to drive projects/tasks to completion.
• Solid team player able to function within a team based organization.
• 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.
• Accountable for technical performance and results of team.
• Manage internal and external relationships.
• Develop strategy and create metrics to measure effectiveness of strategy.
• Translate ambiguity into actionable steps.
• May manage others through influence rather than direct authority.
• Ability to resolve conflicts and coach others on problem solving.
• Handle issues appropriately and with a sense of urgency.
• Prioritize based on business needs.
• Identify and effectively communicate risks.
• Ability to problem solve and identify root cause.
• Ability to communicate at all levels and across various functions.
Education and Experience:
• BS in chemistry, biology or related field with 3+ years' experience in quality control/analytical sciences; minimum of 1 year leading lab investigations in a cGMP environment.
• General quality control laboratory skills (biochemistry, microbiology and/or wet chemistry) and cGMP documentation/compliance skills required.

*Level to be determined based on experience.

This is an opportunity to join our select team that is already leading the way in the Pharmaceutical/Biotech industry. Apply today and learn more about Regeneron's unwavering commitment to combining good science & good business.

To all agencies: 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 will be deemed the sole property of Regeneron, unless such search firms/employment agencies were engaged by Regeneron for this position and a valid agreement with Regeneron is in place. In the event a candidate who was submitted outside of the Regeneron agency engagement process is hired, no fee or payment of any kind will be paid.

Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, sexual orientation, gender identity, disability status, protected veteran status, or any other characteristic protected by law.

Requisition Number: 13169BR