Quality Control Micro Analyst

Location
Rensselaer, NY, United States
Posted
Oct 12, 2020
Ref
19616BR
Discipline
Quality, Quality Control
Required Education
Bachelors Degree
Position Type
Full time
Summary
Performs testing to ensure cGMP compliance of aseptic manufacturing facility and drug product. Responsible for assessing the microbiological quality of aseptically manufactured drug products, manufacturing equipment, manufacturing process areas, and facility utilities.

This a 1st shift position, Monday-Friday, 8am-4:30pm.

Essential Duties and Responsibilities include, but are not limited to, the following
• Perform bioburden, endotoxin and sterility testing of drug products
• Perform testing on raw materials
• Perform sampling and microbiological testing of facility water samples
• Perform gowning qualification and monitoring
• Perform microbial identification testing as needed
• Perform investigations of out of limits or OOS test results and implements corrective action as appropriate
• Assist in environmental/lab investigations as needed
• Ensure testing is performed accurately and in compliance with cGMP procedures, established regulatory requirements (USP), SOPs and other approved test methods
• Assist in writing, reviewing and executing qualification documents for new and existing laboratory equipment
• Assist in continuous improvement initiatives
• Participates in required training activities
• Maintains laboratory supplies and equipment
• Write and revise test protocols and SOPs
• Interacts with customers or functional peer groups
• May be responsible for managing a specific laboratory project

Knowledge, Skills & Abilities
• Working knowledge of sterility testing, isolator technology, environmental and utility monitoring programs
• Ability to perform root cause analysis
• Working knowledge of LIMS
• 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
• Critical thinking skills
• Demonstrates analytical skills through problem-solving
• Demonstrates leadership by being approachable
• Participates in projects in addition to daily responsibilities

Education and Experience
• Requires BS/BA in Microbiology, Biochemistry, Chemistry, Biology or related field with 2+ years of relevant experience in the pharmaceutical or biotechnology industries.
• Experience with sterile drug product manufacturing, pharmaceutical documentation practices, and working knowledge of industry preferred.

Does this sound like you? Apply now to take your first steps toward living the Regeneron Way! We have an inclusive and diverse culture that provides amazing benefits including health and wellness programs, fitness centers and stock for employees at all levels!

Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, nationality, national or ethnic origin, civil status, age, citizenship status, membership of the Traveler community, sexual orientation, disability, genetic information, familial status, marital or registered civil partnership status, pregnancy or maternity status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations. We will ensure that individuals with disabilities are provided reasonable accommodations to participate in the job application process. Please contact us to discuss any accommodations you think you may need.

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