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Supervisor Manufacturing Documentation Support

Job Description

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Within this role you will be responsible for the commercial Manufacturing Documentation team. Facilitate and coordinate Manufacturing records review to meet batch disposition timelines, preparation and review of Cleaning Verification Packs, PRIMR data entry and management of Manufacturing logbooks.

As a Supervisor Manufacturing Documentation Support a typical day might include, but is not limited to, the following:

  • Co-ordinating preparation and reporting of key metrics

  • Driving right first-time completion of manufacturing batch records and timely review and close out of all manufacturing documentation

  • Reviewing and editing batch records in accordance with cGMP standards

  • Facilitating and cataloging manufacturing records, batch sheets & cleaning verification sample packs

  • Serving as a liaison between manufacturing and other functional areas as needed

  • Actively looking for continuous improvement opportunities

  • Performing people management duties including time sheet submissions, scheduling of vacations, personnel development, disciplinary actions, hiring, terminations, and performance evaluations

  • Scheduling individual and ongoing training

  • Ensuring safety standards are maintained at all times

  • Supervising a team, responsible for the co-ordination of manufacturing record review, preparation and review of cleaning verification packs, PRIMR data entry and management of manufacturing logbooks in a cGMP regulatory environment

This role might be for you if:

  • You have experience in technical writing and review of deviations / reports

  • You possess logical troubleshooting and problem-solving skills

  • You have excellent analytical, written and oral communication skills

  • You demonstrate an ability to work within a successful team

Requires BS/BA in Life Sciences or related field with 5+ years of relevant experience in a cGMP environment. Previous supervisory/leadership experience is required as well as technical writing and review of deviations and reports. Equivalent combination of education and experience will be considered.

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Does this sound like you? Apply now to take your first step towards living the Regeneron Way! We have an inclusive and diverse culture that provides comprehensive benefits, which often include (depending on location) health and wellness programs, fitness centers, 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. 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.

For roles in which the hired candidate will be working in the U.S., the salary ranges provided are shown in accordance with U.S. law and apply to U.S.-based positions. For roles which will be based in Japan and/or Canada, the salary ranges are shown in accordance with the applicable local law and currency. If you are outside the U.S, Japan or Canada, please speak with your recruiter about salaries and benefits in your location.

Please note that certain background checks will form part of the recruitment process. Background checks will be conducted in accordance with the law of the country where the position is based, including the type of background checks conducted. The purpose of carrying out such checks is for Regeneron to verify certain information regarding a candidate prior to the commencement of employment such as identity, right to work, educational qualifications etc.