Senior Quality Assurance Validation Specialist

Regeneron Pharmaceuticals, Inc (USA); United States; On-site; USD 67,400 - 128,700; Full time

Benefits offered by this job

Student loan paydown program & tuition

Family care benefits

Relocation assistance

Inclusion, culture and well-being

Job summary

Regeneron Pharmaceuticals, Inc. is seeking a Sr. QA Validation Specialist to validate/qualify equipment, systems, and processes in line with regulatory requirements. You will support manufacturing standards and procedures within a fast-growing, science-driven organization based in Rensselaer, NY, with a Monday–Friday schedule.

The role requires a B.S. in life sciences (or equivalent) and 4+ years (Sr. 6+ years) of QA validation experience, plus responsibility for deviation investigations, change

Qualifications

• B.S in life sciences or related field; may substitute proven experience for education requirement.
• QA Validation Specialist: 4+ years of experience; Sr. QA Validation Specialist: 6+ years of experience.

Responsibilities

• Generates, executes and reviews qualification and validation protocols and reports.
• Analyzes test results against predetermined criteria and documents outcomes.
• Investigates problems and proposes solutions or improvements.
• Reviews and approves deviation notifications, investigations, and corrective actions.
• Coordinates with other departments or vendors to complete validation tasks.
• Performs temperature mapping, packaging qualification, and cold-chain testing.

Skills

QA Validation

Qualification

Deviation handling

Change controls

Documentation

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 are seeking a Sr. QA Validation Specialist to join our Quality Assurance team. As the Senior QA Validation Specialist, you will validate/qualify equipment, systems, and processes in accordance with regulatory requirements and support, follow and implement company manufacturing standards policies and procedures. This position offers the opportunity to contribute to a fast-growing, science-driven organization making a meaningful difference to patients worldwide.

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

What you’ll do:

• Generates, executes and/or reviews master and completed qualification and validation protocols, summary reports and associated data for conformance to regulations, SOPs, specifications and other applicable acceptance criteria
• Analyzes the results of testing and determines the acceptability of results against pre-determined criteria
• Investigates and troubleshoots problems which occur and determines solutions or recommendations for changes and/or improvements
• Reviews, edits and approves deviation notifications, deviation investigations, and corrective actions
• Reviews, edits and approves change controls, SOPs, reports and other documentation
• Coordinates with other departments or outside contractors/vendors to complete validation tasks
• Executed real-world and simulated transport studies, including gross-damage visual inspections, pallet configuration assessments, and qualification of secondary and tertiary packaging materials
• Conducts temperature mapping for controlled environments and distribution lanes
• Programs and deploys instrumentation to capture vibration and shock profiles; analyzed data to inform packaging design and handling recommendations
• Programs humidity and pressure sensors and interpreted datasets to support test plans and root-cause analysis
• Applies ASTM and/or ISTA standards to cold-chain shipping design, testing, and qualification
• Performs small-parcel and palletized-load qualifications, including test planning, execution, and reporting

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

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 QA Validation Specialist: 4 + years of experience Sr. QA Validation 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

Salary Range (annually) $67,400.00 - $128,700.00

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.

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.

We are committed to building a workplace with an inclusive culture.

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.

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.

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.