QA Specialist - QA for Quality Control

The QA department is hiring! The QA Specialist for QC applies functional knowledge in the Quality function. This individual will complete information analysis and assist in implementing industry standard processes for GMP across quality controls and laboratory areas. They will ensure that procedures, products, and documentation enforce to internal standards as well as those of the regulatory agencies.

As a QA Specialist, a typical day might include the following:

• Interacts with Quality Control laboratories, support laboratories, and Facilities to ensure a successful compliance profile

• Provides consultation or advice in alignment with QA policies

• Active participation in investigation, evaluation, and problem resolution in support of Deviations, Change Controls, CAPAs, etc.

• 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

• Train and/or mentor junior employees, including providing insights and education on processes and procedures

• Ensures safety and operational standards are maintained

This role may be for you if you have:

• Good understanding of analytical laboratory and biologics manufacturing operations is helpful; experience with facility or laboratory start-up, technology transfer, or validation

• Prior experience within a Quality Assurance or Quality Control function

• Good interpersonal 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 apply computerized systems for daily performance of tasks

• Ability to prioritize, manage multiple tasks, and meet deadlines

To be considered for this position, you must hold a BS/BA in scientific subject area or related field and

• Associate QA Specialist: 2+ years related experience

• QA Specialist: 4 years related experience

• Senior QA Specialist: 6 years relevant experience.

• Experience in the pharmaceutical/biotechnology industry (biotech preferred)

• Relevant experience may be substituted for education requirement

#REGNQA

Does this sound like you? Apply now to take your first steps toward living the Regeneron Way! We have an inclusive and diverse culture that provides comprehensive benefits including health and wellness programs, fitness centers and equity awards, annual bonuses, and paid time off for eligible employees at all levels!

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, nationality, national or ethnic origin, civil status, age, citizenship status, membership of the Traveler community, sexual orientation, disability, genetic information, familial status, marital or registered civil partnership status, pregnancy or parental status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations. We will ensure that individuals with disabilities are provided reasonable accommodations to participate in the job application process. Please contact us to discuss any accommodations you think you may need.

The salary ranges provided are shown in accordance with U.S. law and apply to U.S. based positions, where the hired candidate will be located in the U.S. If you are outside the U.S, please speak with your recruiter about salaries and benefits in your location.

Salary Range (annually)

$55,700.00 - $121,300.00