Supervisor Manufacturing Documentation Support

2 weeks ago

Dublin, Dublin City, Ireland Regeneron Pharmaceuticals, Inc Full time
Supervisor Manufacturing Documentation Support

Within this position, you will oversee the commercial Manufacturing Documentation team. Responsibilities include coordinating Manufacturing records review to meet batch disposition timelines, preparing and reviewing Cleaning Verification Packs, PRIMR data entry, and managing Manufacturing logbooks.

Key Responsibilities:

  • Coordinating preparation and reporting of key metrics
  • Ensuring right first-time completion of manufacturing batch records and timely review
  • Reviewing and editing batch records per cGMP standards
  • Facilitating and cataloging Manufacturing Records, Batch Sheets & Cleaning Verification sample packs
  • Serving as a liaison between manufacturing and other departments as necessary
  • Identifying Continuous improvement opportunities
  • Overseeing personnel management tasks such as time sheet submissions, vacation scheduling, disciplinary actions, and performance evaluations
  • Scheduling individual and ongoing training
  • Upholding safety standards
  • Supervising a team responsible for manufacturing record review, Cleaning Verification Packs preparation, PRIMR data entry, and logbook management in a cGMP regulatory setting

Qualifications:

  • Experience in Technical writing and deviation/report review
  • Strong troubleshooting and problem-solving skills
  • Excellent analytical, written, and oral communication abilities
  • Demonstrated team player
  • BS/BA in Life Sciences or related field with 5+ years of relevant cGMP manufacturing experience and some supervisory/leadership background

If you fit the profile described and are looking for a dynamic work environment with comprehensive benefits, apply today and take the first step towards embracing the Regeneron culture. Join us in a workplace that values inclusivity and diversity offering health and wellness programs, fitness facilities, equity awards, bonuses, and paid time off for eligible staff.

Regeneron is committed to providing equal employment opportunities to all qualified candidates without regard to race, color, religion, sex, nationality, age, disability, genetic information, gender identity, veteran status, or any other protected characteristic under applicable regulations. Reasonable accommodations will be provided to individuals with disabilities throughout the recruitment process. Salary ranges are compliant with U.S. regulations and apply to positions within the country. For candidates outside the U.S., details on salaries and benefits will be provided based on the location.

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