Supervisor, Quality Assurance Specialist (Overnight)

BioSpace; City of Rensselaer (NY); On-site; USD 79,000 - 129,000; Full time

Job summary

Regeneron is seeking a Senior Quality Assurance Specialist to lead floor activities, dispositioning products and raw materials, ensuring compliance with QA policies, cGMPs, and SOPs. The role involves investigation, document review, and cross-functional collaboration with external partners.

The position requires on-the-floor presence, mentoring of staff, and ongoing process improvements. Location is Rensselaer, NY with a 3rd shift schedule; on-site work is expected.

Qualifications

• BS/BA in Life Sciences, Engineering or related field; or equivalent combination of education and experience.
• Principal QA Specialist: 6+ years of relevant experience; Staff QA Specialist: 8+ years of relevant experience
• Experience with sterile drug product manufacturing, fill finish and/or quality control testing

Responsibilities

• Represent QA in support of deviations, change controls, CAPAs, including investigation, evaluation, and problem resolution.
• Represents QA with external partners to communicate QA policy and procedures; liaise with external partners and provide input on regulatory communication
• Train and/or mentor employees, including QA process education and setting expectations of QA organization
• Provides on-the-floor QA guidance to events or questions that may arise in alignment with QA policies
• Perform activities associated with disposition of product (e.g., manufacturing record review, document review, source data review)
• Review, edit, or approve Regeneron controlled documents
• Review and approve investigations associated with product or processes
• Continually evaluating Regeneron processes and procedures toward continuous improvement
• Supervising direct reports
• Monthly performance feedback meetings with direct reports

Skills

QA on-floor

Deviations & CAPAs

Regulatory liaison

Training & mentoring

Document review

Education

BS/BA in Life Sciences, Engineering or related field

Job description

Build Our Future Together

At Regeneron, we use science and innovation to develop life-changing medicines for people with serious diseases. We are seeking a Senior Quality Assurance Specialist position. This position performs and leads activities on the floor in support of dispositioning product and/or raw materials while ensuring compliance with Quality Assurance (QA) policies and procedures, cGMPs, SOPs, and Regeneron Standard Requirement Documents.

Build Our Future Together

At Regeneron, we use science and innovation to develop life-changing medicines for people with serious diseases. We are seeking a Senior Quality Assurance Specialist position. This position performs and leads activities on the floor in support of dispositioning product and/or raw materials while ensuring compliance with Quality Assurance (QA) policies and procedures, cGMPs, SOPs, and Regeneron Standard Requirement Documents.

Where & Where

Location: Rensselaer, New York, United States

Work model: Wednesday-Sunday, 3rd shift, 10:00 PM - 8:30 AM

Discover Your Role

• Represent Quality Assurance in support of complex and/or significant Deviations, Change Controls, CAPAs, etc., including active participation in investigation, evaluation, and problem resolution
• Represents the organization on behalf of QA with external partners to communicate QA policy and procedures; liaise with external partners and provide input on regulatory communication
• Train and/or mentor employees, including providing insights and education on processes and procedures, and conveying expectations of QA organization
• Provides consultation or advice in alignment with QA policies through a continuous on the floor presence, working with stakeholders by providing QA guidance to events or questions that may arise
• Perform activities associated with disposition of product (e.g., manufacturing record review, document review, source data review etc.)
• Review, edit, or approve Regeneron controlled documents
• Review and approve investigations associated with product or processes
• Continually evaluating Regeneron processes and procedures with an eye toward continuous improvement
• Supervising direct reports
• Participates with employee training to ensure that all requirements are met.
• Performs, minimally, monthly performance feedback meetings with direct reports.

This Role Requires

• BS/BA in Life Sciences, Engineering or related field; or equivalent combination of education and experience
• Principal QA Specialist: 6+ years of relevant experience
• Staff QA Specialist: 8+ years of relevant experience
• Experience with sterile drug product manufacturing, fill finish and/or quality control testing
• Level will be determined based on experience

This Role May Be For You If You

• Excel in a quality driven organization
• Have an understanding of biologics manufacturing operations
• Are organized and have an attention to detail
• Can prioritize multiple assignments and changing priorities
• Are able to stand for periods of time when performing tasks on the floor

Gowning And Environment

• Full cleanroom attire (Examples may include: including laundered undergarments, gown, facemask, hairnet, safety glasses, safety shoes and booties, latex gloves and the use of sanitizing agents during gowning process including IPA)
• Ability to remove jewelry, make-up and nail adornments when wearing cleanroom attire

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.

Please be advised that at Regeneron, we believe we do our best work when we are together. For that reason, many roles are required to be performed onsite.

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)

$78,700.00 - $128,700.00