Supervisor, Document Control (2nd Shift)

Location
Rensselaer, New York, US
Posted
Jul 13, 2018
Ref
13647BR
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: Provides support to the Rensselaer site related to documentation system and ancillary support systems. Supervises Document Control Coordinators.

Essential Duties and Responsibilities include, but are not limited to, the following:

• Prepares status reports for management.

• Coordinates review and revision of controlled documents.

• Supervises and guides subordinates to ensure that tasks are completed.

• Counsels employees about work performance.

• As appropriate, trains staff and user departments in documentation systems.

• Provides guidance/training to Doc Control staff and user departments in proper use of the document change systems to ensure consistency of system usage.

• Reviews/Approves administrative changes to controlled documents for Quality Assurance.

• Coordinates document requests and stages documents for presentation during regulatory inspections.

• Implements and maintains document repositories and archives.

• Issues and maintains master manufacturing documentation and supporting documentation.

• Investigates and manages compliance items for department.

Knowledge, Skills and Abilities:

• 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

• Coordinate, organize and assign daily activities of operations

• Support employees, executing against established guidelines and common procedures and policies

• Ability to provide feedback and career counseling

• Ability to effectively manage high-stress situations

• Ability to motivate employees and build team morale

• Strong leader and teacher

• Demonstrated flexibility during ambiguous situations

• Ability to identify problems and escalate accordingly

**2nd Shift position: Monday-Friday, 1:30pm-10:00pm**
Education and Experience:

• Requires a BS/BA in related field with 5+ years of related experience. cGMP environment experience preferred, but will consider other relevant QA/Document Control experience. May substitute relevant experience in lieu of educational requirement.

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.