QC Micro Analyst

Rensselaer, NY, United States
Feb 22, 2019
Quality, Quality Control
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: Performs testing to ensure cGMP compliance in the manufacturing facility. Responsible for assessing the microbiological quality of products, manufacturing equipment, manufacturing process areas, and facility utilities.

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

• Reviews and updates SOPs.

• Performs peer review of data.

• Performs laboratory investigation reports.

• Participates in training of other employees.

• Performs microbial identification procedures.

• Maintains laboratory supplies, media, and reagents inventory.

• Participates in the overtime and weekend schedule as required.

• Performs bioburden and endotoxin testing of products and raw materials.

• Performs microbiological testing of in-process and final product materials.

• Performs biological and endotoxin indicator testing used in the validation of manufacturing equipment.

• Updates microbiological environmental monitoring results database and prepares monthly report.

• Performs acceptance testing of commercially prepared microbiological culture media.

• Assists in coordinating equipment maintenance and calibration.

• Uses Laboratory Information Management System (LIMS) for sample and sample test result tracking.

• Performs all duties relevant to the Quality Control Microbiology Technician position as required.

• Performs routine and specialized evaluations of finished products, stability and special project test samples.

• Applies sound, scientific principles to solve problems.

• Provides technical training support as required.

Additional responsibilities for Analysts II-IV include, but are not limited to:

• Increasing involvement in the training of employees.

• Increasing responsibilities for reviewing documents and data.

• Microbiology representation and participation in cross functional site meetings.

• Administration of programs such as gowning, training, ordering, calibration, etc.

• Technical writing assignments such as SOPs, protocols, final reports, trend reports, risk assessments, laboratory investigations, etc.

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 multi-task

• Ability to analyze and identify trends

• Develops and delivers effective presentations

• Problem-solving skills

• Ability to train others on basic systems and processes

• Strong written communication

• Ability to work in an ever-changing environment

• Critical thinking skills

• Knowledge of bioburden and endotoxin testing preferred

Education and Experience:

• Requires BS/BA in Life Sciences or equivalent and 2+ years of related experience. Will substitute relevant work experience in lieu of degree requirement.

• Prior GMP experience required.

*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.