QA Specialist, Drug Product

Regeneron Pharmaceuticals; Rensselaer (IN); On-site; USD 62,000 - 110,000; Full time

Benefits offered by this job

Student loan paydown

Family care benefits

Relocation assistance

Inclusion programs

Job summary

Regeneron Pharmaceuticals in Rensselaer, NY is seeking a QA Specialist to join our QA Drug Product team. You will support start-up and operation activities, develop SOPs, review documents, mentor manufacturing staff, and contribute to audits and investigations.

This role requires a BS in life sciences or related field, with 2+ years for Associate level or 4+ years for Specialist, and the ability to work on the floor in a cleanroom environment.

Qualifications

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

Responsibilities

• Establish new programs for start-up of drug product operations such as formulation, filling, inspection, assembly, and pack/label.
• Develop, write, review, and approve SOPs, specifications, and other documents.
• Maintain project timelines and on-the-floor quality review of documents and records.
• Mentor manufacturing personnel on the floor and support audits, inspections and investigations.

Skills

Quality Assurance

Document control

SOP development

Audits & inspections

Cross-functional collaboration

Education

BS in life sciences

Tools

Document control systems

Job description

At Regeneron, we use science and innovation to develop life-changing medicines for people with serious diseases. Regeneron is currently seeking a Quality Assurance (QA) Specialist to join our QA Drug Product team. This position will support QA initiatives for a broad range of topics relative to the start-up and operations of a drug product facility. This position offers the opportunity to contribute to a fast-growing, science-driven organization making a meaningful difference to patients worldwide.

When & where:

• 1st shift, Monday-Friday, 8am-4:30pm
• Location: Rensselaer, New York, United States

What you’ll do:

• Work on and potentially lead efforts to establish new programs including start-up of formulation, filling, inspection, assembly, and pack and label team
• Perform assessments of existing procedures/documents to gauge appropriateness for the inclusion of drug product operations; where current documents are not adequate, identify path forward for establishment of procedures
• Develop, write, review, and approve SOPs, specifications, and other documents. This includes documents for operation and facility SOPs, quality training, batch documentation, etc.
• Maintain project timelines to support the evolving business
• Perform on-the-floor quality review of documents, such as: equipment logs, training records, testing results, batch records and supporting documents
• Review and approval of documents (electronic and paper-based)
• Provide mentorship during on-the-floor manufacturing
• Support audits, inspections and investigations
• Perform quarantine, segregation of material and line clearances
• Contribute to the continuous improvement initiatives
• Adjust schedule based on facility start up, filling, and manufacturing needs
• Collaborate with cross-functional internal teams

The environment and physical rhythms of this role:

• Gowning: 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
• Ability to perform physical requirements for entirety of shift (up to 10 hours) in a clean room environment
• Some physical requirements can include but not limited to: bending, climbing, crawling, kneeling, reaching, reaching overhead, sitting, squatting, walking, standing, driving, hand manipulation and ability to lift/push/pull up to 50lbs

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
  • Assoc QA Specialist : 2+ years of experience
  • QA Specialist : 4 + 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)

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. If you have any questions, please speak with your recruiter.

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. Please speak with your recruiter and hiring manager for more information about on-site expectations for your role and location.

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