Assoc QA Raw Material Specialist

Regulatory Jobs; City of Rensselaer (NY); On-site; USD 62,000 - 92,000; Full time

Job summary

Regeneron is seeking a QA professional to support dispositioning of product and raw materials in alignment with QA policies, cGMPs, and Regeneron standards. The role involves investigation support, batch record reviews, and regulatory communications.

The candidate will train junior staff, provide process insights, and ensure proper documentation plus adherence to Regeneron processes, with potential CI initiatives and on-site work requirements.

Qualifications

• BS/BA in scientific discipline with 2+ years QA/Regulatory experience
• BS/BA in scientific discipline with 4+ years QA/Regulatory experience
• BS/BA in scientific discipline with 6+ years QA/Regulatory experience

Responsibilities

• Represent QA in investigations, deviations, CAPAs, and resolutions.
• Review and approve batch records.
• Communicate QA policies; liaise with internal/external partners.
• Train and mentor junior staff on processes and procedures.
• Provide QA policy consultation.
• Dispositon of raw materials and product (receipt, inspection, doc review, shipping).
• Review/edit Regeneron controlled documents.
• Review/approve investigations related to materials or product.
• Perform status labeling of product.
• Adhere to Regeneron processes; lead Continuous Improvement initiatives.

Skills

QA compliance

Deviations management

Batch review

Regulatory documents

Training/mentoring

Cross-functional collaboration

Documentation

Education

BS/BA in scientific discipline

BS/BA in scientific discipline (4+ years experience)

BS/BA in scientific discipline (6+ years experience)

Job description

Summary: Performs activities 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.

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

• Represent Quality Assurance in support of complex Deviations, Change Controls, CAPAs, etc., including active participation in investigation, evaluation, and problem resolution
• Review and approve batch records
• Communicate QA policy and procedures; liaise with internal or external partners and stakeholders and provide input on regulatory communications
• Train and/or mentor junior employees, including providing insights and education on processes and procedures;
• Provides consultation or advice in alignment with QA policies;
• Perform activities associated with disposition of raw materials and product (e.g. receipt, inspection, document review, shipping, etc.). Activities may be on the floor or at a desk
• Review, edit, or approve Regeneron controlled documents
• Review and approval of investigations associated with raw materials or product
• Perform status labeling of product
• Adheres to Regeneron processes and procedures and may lead Continuous Improvement initiatives

Education and Experience:

• Assoc QA Specialist: Requires BS/BA in scientific discipline or related field and minimum 2 years relevant experience. May substitute proven experience for education requirement.
• Specialist: Requires BS/BA in a scientific discipline or related field and minimum of 4 years relevant experience. May substitute proven experience for education requirement.
• Sr Specialist: Requires a BS/BA in a scientific discipline or related field and minimum 6 years relevant experience. May substitute proven experience for education requirement.

Knowledge, skills, and abilities:

• Understanding of biologics manufacturing operations is preferred
• Good organizational skills and attention to detail
• Requires good written, verbal and interpersonal communication skills and the ability to effectively interact cross functionally.
• Ability to handle multiple assignments and changing priorities.
• Ability to learn and utilize computerized systems for daily performance of tasks
• Ability to prioritize, manage multiple tasks, and meet deadlines
• Ability to stand for periods of time when performing tasks on the floor (Raw Materials).
• Ability to work a varied schedule including off shift and weekends.
• Ability to lift up to 50 pounds (Raw Materials).

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 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 - $92,400.00