Job Description
Performs activities in support of disposition of product while ensuring compliance with Quality Assurance (QA) policies and procedures, cGMPs, SOPs, and Regeneron Standard Requirement Documents.
As a typical day may include the following:
1. Preparing & reviewing batch disposition documentation to support QP release of Formulated Drug Substance
2. Reviewing QC related release data and documentation
3. Completing deviation, change control & batch record reports to support disposition
4. Performing status labelling of product as needed
5. Representing Quality Assurance in support of deviations, CAPAs, etc.
6. Representing the IOPS organisation on behalf of QA with external partners to communicate QA policies and procedures; liaising with external partners and providing input on regulatory communications
7. Training & mentoring employees, including providing insights on processes and procedures, and conveying QA expectations
8. Providing consultation or advice in line with QA policies; reviewing, editing, or approving controlled documents
9. Interacting with various departments to ensure batch release deliverables are met
10. Evaluating Regeneron processes and procedures with an eye toward continuous improvement
This role might be for you if:
* You have an understanding of biologics manufacturing operations
* You possess excellent organisational skills and attention to detail
* You have good written, verbal, and interpersonal communication skills and can interact cross-functionally effectively
* You can prioritise multiple assignments and adapt to changing priorities
* You are able to learn and utilise computerised systems for daily tasks
* You can manage multiple tasks and meet deadlines
To be considered, you must have a Degree or Masters in a scientific field. Experience requirements vary by level: Associate (0-2 years), Specialist (3 years), Sr. Specialist (5+ years).
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Does this sound like you? Apply now to take your first step towards living the Regeneron Way We offer an inclusive and diverse culture with comprehensive benefits, including health and wellness programs, fitness centers, equity awards, bonuses, and paid time off.
Regeneron is an equal opportunity employer. All qualified applicants will receive consideration without regard to race, color, religion, sex, nationality, ethnicity, civil status, age, citizenship, sexual orientation, disability, genetic info, family or marital status, gender identity, military status, or other protected characteristics. Reasonable accommodations are provided for disabilities or chronic illnesses unless undue hardship occurs.
Salary ranges are provided in accordance with local laws for U.S., Japan, and Canada roles. Please consult with your recruiter for details outside these locations.
Note: Background checks will be part of the recruitment process, conducted in accordance with applicable laws, to verify information such as identity, right to work, and educational qualifications.
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