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Associate Manager QA

4 months ago

East Greenbush, United States Regeneron Pharmaceuticals Inc. Full time

We are currently looking to fill an Associate Manager QA (Visual Inspection) position. This position is responsible for the leadership, development, and oversight of the Quality Assurance team supporting Visual Inspection operations at Regeneron’s internal Fill/Finish facility. This position will also contribute to establishing procedures and policies during the start-up of the facility to ensure assigned areas are operating to current FDA and International Regulatory Body requirements.

**Available Work Schedules**:
Monday-Friday, 1st shift

**In this role, a typical day might include the following**:
Monitor and update policies and procedures to ensure the highest quality standards are maintained. Areas of responsibility may include Equipment and assistance for Visual Inspection

Lead, set expectations, schedule, and monitor performance standards and goals of assigned team(s) to ensure optimal performance. Ensure teams possess the required skills and knowledge, and are appropriately trained, to support plant operations.

Ensure compliance with all regulatory requirements and good documentation practices to provide a safe, quality, and effective product.

Provide first response for Quality and Compliance issues encountered on the manufacturing floor.

Represent Quality Assurance in support of Deviations, Change Controls, CAPAs, etc., including active participation in investigation, evaluation, and problem resolution.

Review, edit, or approve Regeneron controlled documents. May review or approve Master Batch Records.

Participate in regulatory inspections; able to influence standards and challenge the status quo.

Be accountable for maintaining project timelines associated with initiatives to support the evolving business.

Implement operational and strategic policies and directives; influence others to achieve results.

**This role may be for you if you**:
Are able to pass a visual acuity exam according to SOP requirements

Have knowledge of cGMP manufacturing environment and familiarity with visual inspection of liquid and lyophilized products

Have knowledge of assembly, labeling and packaging operations is preferred

Are experienced using and / or developing qualification kits and qualifying operators

Possess proven strong interpersonal, cross
- cultural, communication, negotiation and problem-solving skills

Exhibit confidence, has a high emotional IQ, and demonstrated ingenuity, creativity and resourcefulness

Understand and listen to team members and stakeholders’ needs while supporting a positive team environment

Have 2+ years of experience leading and developing a team.
To be considered for this role you must hold a Bachelor’s degree in a Life Sciences or related field and the following minimum amounts of relevant experience in a Quality or Manufacturing role, preferably in a cGMP controlled/regulated industry for each level:
Associate Manager - 6+ years
Pharmaceutical experience preferred. May substitute proven experience for education requirement. Level is determined based on qualifications relevant to the role.
REGNQA
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. The Company will also provide reasonable accommodation to the known disabilities or chronic illnesses of an otherwise qualified applicant for employment, unless the accommodation would impose undue hardship on the operation of the Company's business.
Salary Range (annually) $89,100.00 - $145,500.00