Quality Assurance Specialist, Lab Support

Regeneron Pharmaceuticals, Inc (USA); United States; On-site; USD 62,000 - 110,000; Full time

Benefits offered by this job

Student loan paydown program & tuition

Family care benefits

Relocation assistance

Inclusion & well-being programs

Job summary

Regeneron Pharmaceuticals, Inc. is seeking a Quality Assurance Specialist to support lab operations at our Rensselaer, NY facility. The role focuses on QA policy adherence, data review, and CAPA/change control activities to ensure cGMP compliance.

You will partner with QC labs, facilities, and external teams to maintain a strong quality profile. The ideal candidate has a life sciences background with 4+ years of QA experience, and the ability to train and guide junior staff while driving

Qualifications

• Requires B.S in life sciences or related field; may substitute proven experience for education requirement.

Responsibilities

• Communicates QA policy and procedures.
• liaises with Quality Control laboratories, support laboratories, facilities, internal or external partners and stakeholders to ensure a successful compliance profile.
• Represents Quality Assurance in support of complex Deviations, Change Controls, CAPAs, etc., including active participation in investigation, evaluation, and problem resolution.
• Actively participates in QC laboratory oversight activities such as data review and laboratory walkthroughs.
• Performs activities associated with review, edit, and approval of QC generated documentation. Activities may be on the floor or at a desk.
• Collaborates with key partners in the business to proactively identify areas for improvement and develop solution strategies.
• Trains and/or mentors junior employees, including providing insights and education on processes and procedures.
• Provides consultation or advice in alignment with QA policies.
• Adheres to Regeneron processes and procedures and may lead Continuous Improvement initiatives.
• Demonstrate good understanding of analytical laboratory and biologics manufacturing operations is preferred

Skills

QA policy & procedures

Lab support

Deviations & CAPAs

Documentation review

Regulatory compliance

Mentoring junior staff

Education

Bachelor's degree in life sciences

Job description

At Regeneron, we use science and innovation to develop life-changing medicines for people with serious diseases. We’re seeking a Quality Assurance (QA) Specialist to focus on lab support for our fill finish facility and quality control laboratory areas. They will ensure compliance with Quality Assurance (QA) policies and procedures, cGMPs, SOPs, and Regeneron Standard Requirement Documents.

When & where: Location: Rensselaer, New York, United States Work model: Monday-Friday, 8am-4:30pm

What you’ll do:

• Communicates QA policy and procedures;
• liaises with Quality Control laboratories, support laboratories, facilities, internal or external partners and stakeholders to ensure a successful compliance profile;
• Represents Quality Assurance in support of complex Deviations, Change Controls, CAPAs, etc., including active participation in investigation, evaluation, and problem resolution;
• Actively participates in QC laboratory oversight activities such as data review and laboratory walkthroughs;
• Performs activities associated with review, edit, and approval of QC generated documentation. Activities may be on the floor or at a desk;
• Collaborates with key partners in the business to proactively identify areas for improvement and develop solution strategies;
• Trains and/or mentors junior employees, including providing insights and education on processes and procedures;
• Provides consultation or advice in alignment with QA policies;
• Adheres to Regeneron processes and procedures and may lead Continuous Improvement initiatives;
• Demonstrate good understanding of analytical laboratory and biologics manufacturing operations is preferred

Let’s find out if we’re a fit:

Requires B.S in life sciences or related field; may substitute proven experience for education requirement

• Associate Quality Assurance Specialist: 2+ years of experience
• Quality Assurance Specialist: 4+ years of experience
• Senior Quality Assurance Specialist: 6+ years of experience

Level will be determined based on experience.

Thrive today.

Grow tomorrow.

• Student loan paydown program & tuition reimbursement
• Family care benefits
• Relocation assistance
• Inclusion, culture and well-being programs (including physical & mental health)
• #REGNQA

Does this sound like you?

Regeneron is committed to building a workplace with an inclusive culture. 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, sexual orientation, gender identity or expression, gender reassignment, marital or civil partnership status, civil status, pregnancy or parental status, age, disability, nationality, citizenship status, ethnic or national origin, membership of the Traveler community, familial status, genetic information, military or veteran status, or any other characteristic protected under applicable law. Where required, we will provide reasonable accommodation to applicants with known disabilities or chronic illnesses during the recruitment process, unless such accommodation would impose undue hardship.

Where necessary, we disclose salary ranges for roles in all countries in which we operate. The final offer will be determined within the relevant range based on the country of employment, specific role level, and your skills and experience. In some countries, collective bargaining agreements (CBAs) may apply and influence certain elements of pay or benefits.

Regeneron offers a competitive and comprehensive total rewards package which may include, depending on country and role: annual bonuses or other incentive plans, equity awards, pension or retirement benefits, 401(k) company match, health and wellness programs, fitness centers, insurance benefits (e.g. medical, dental, vision, life and disability), paid time off, and family support benefits.

For additional information about Regeneron benefits in the U.S., please visit https://careers.regeneron.com/en/working-at-regeneron/total-rewards/.

For other locations, additional information will be provided during the recruitment process.

For jobs in Canada: this posting is for an existing position.

Salary Range (annually) $62,355.00 - $110,000.00

Regeneron is a leading biotechnology company that invents life-transforming medicines for people with serious diseases. Founded and led for over 30 years by physician-scientists, our unique ability to repeatedly and consistently translate science into medicine has led to nine FDA-approved treatments and numerous product candidates in development, almost all of which were homegrown in our laboratories. Our medicines and pipeline are designed to help patients with eye diseases, allergic and inflammatory diseases, cancer, cardiovascular and metabolic diseases, neurology, infectious diseases and rare diseases. Regeneron is also proud of award winning culture of innovation, being recognized as a Great Place to Work in 2021, Fast Company’s Best Workplace for Innovators in 2020, and Forbes JUST companies in 2020, among others.