Sr. Quality Auditing Coordinator

Rensselaer, NY, United States
Mar 23, 2019
Required Education
Bachelors Degree
Position Type
Full time
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: Responsible for coordinating logistics for team meetings and for internal audits; providing on site assistance to the GCP remote audit team; assisting with the generation of SOWs and submitting requisition requests for consultant auditors; assisting with the maintenance of the internal and external audit schedules, including processing audit schedule changes; maintaining audit files and the QAA Auditing SharePoint site; requisitioning supplies. Depending on experience, may also assist with audit conduct.

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

• Assisting with the management and support of the clinical audit programs and corresponding trackers;

• Assisting with the maintenance of the internal and external audit schedules;

• Assisting with processing audit schedule changes;

• Coordinating logistics for internal audits and team meetings;

• On site point of contact for remote audit team;

• Assisting auditors with schedule activities, maintenance and updates;

• Leading and tracking activities to ensure audit files are completed by the auditors, reconciled and maintained in a timely fashion;

• Liaising with consultant auditors/trainers/etc. to obtain, submit and process compliant SOWs;

• Processing departmental requisition requests;

• Maintaining consultant auditor files;

• QC of various audit documents to ensure adherence to procedure, accuracy and completeness;

• Planning, leading and performing special projects as assigned by management;

• Performing and maintaining personal training by scheduled due dates;

• Ensuring auditing processes and procedures are followed and deviations and changes, if any, are documented and handled following appropriate processes and procedures;

• Participating in inspection readiness and inspections as needed.

Knowledge, Skills & 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

• Ability to interpret data and develop improvement plan

• Initiating the development of leadership skills by providing training and guidance to others

• Anticipates and plans for change

• Exhibits good judgement and decision-making ability

• Demonstrates leadership by being approachable

Education and Experience:

• Requires BA/BS degree and 2+ years of pharmaceutical/biotechnology experience.

• Will substitute relevant work experience in lieu of degree requirement.

*Level will be determined by education and 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.