Quality Assurance Specialist, Lab Support

Regeneron; City of Rensselaer (NY); In loco; USD 62.000 - 110.000; Tempo pieno

Vantaggi offerti da questo lavoro

Student loan paydown

Tuition reimbursement

Family care benefits

Relocation assistance

Inclusion programs

Descrizione del lavoro

Regeneron is seeking a Quality Assurance (QA) Specialist to support lab operations in our Rensselaer, NY facility. The role focuses on QA policy adherence, cGMPs, and documentation review for QC and manufacturing areas. You will participate in deviations, CAPAs, investigations and continuous improvement initiatives.

Qualified candidates have a life sciences BS and 2+ years (Assoc), 4+ years (Specialist), or 6+ years (Senior) of QA experience. On-site schedule is Mon-Fri, 8:00 a.m.–4:30 p.m.

Competenze

• Requires B.S in life sciences or related field; may substitute proven experience for education
• Associate QA Specialist: 2+ years of experience
• Quality Assurance Specialist: 4+ years of experience
• Senior Quality Assurance Specialist: 6+ years of experience

Mansioni

• Communicates QA policy and procedures; liaises with Quality Control labs and stakeholders to ensure compliance
• Represents QA in Deviations, Change Controls, CAPAs and investigations
• Participates in QC lab oversight, data review, and walkthroughs
• Reviews, edits, and approves QC documentation, on-floor or desk-based
• Collaborates with partners to identify improvements and develop solutions
• Trains and mentors junior staff and shares process knowledge
• Provides QA guidance in alignment with policies
• Supports ongoing Regeneron processes and may lead improvement initiatives
• Shows understanding of analytical lab and biologics manufacturing operations

Conoscenze

QA policies

cGMPs

Documentation

Investigation

Collaboration

Formazione

B.S. in life sciences

Experience substitution allowed

Descrizione del lavoro

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? We are 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.

many roles are required to be performed on‑site.

As part of the recruitment process, certain background checks may be conducted in accordance with the laws of the country where the position is based. The purpose of such checks is to verify certain information prior to the commencement of employment such as identity, right to work and educational qualifications.

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

Salary Range (annually)

$62,355.00 - $110,000.00