QA Specialist-(Batch Release)-Multi Level

1 week ago

Limerick, Limerick, Ireland Regeneron Full time

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:

  • Preparing & reviewing of batch disposition documentation to support QP release of Formulated Drug Substance
  • Reviewing of QC related release data, Documentation review
  • Completing deviation, change control & batch record reports to support disposition
  • Performing status labelling of product as the need arises
  • Representing Quality Assurance in support of deviations, CAPAs, etc.
  • Representing the IOPS organisation on behalf of QA with external partners to communicate IOPS QA policy and procedures; liaise with external partners and provide input on regulatory communications
  • Training & mentoring employees, including providing insights and education on processes and procedures, and conveying expectations of QA organisation
  • Providing consultation or advice in alignment with QA policies; review, edit, or approve controlled documents
  • Interacting with various departments to ensure batch release deliverables are met
  • 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 have excellent organisational skills and attention to detail
  • You have good written, verbal and interpersonal communication skills and the ability to optimally interact cross-functionally
  • You have the ability to prioritise multiple assignments and changing priorities
  • You have the ability to learn and utilise computerised systems for daily performance of tasks
  • You can prioritise, manage multiple tasks, and meet deadlines

To be considered for this opportunity you must have a Degree or Masters in a scientific field. Associate Level requires 0-2 years experience, for Specialist level 3 years experience is required and Sr Specialist you must have 5+ years of directly related experience.

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.

#J-18808-Ljbffr

  • QA Specialist-(Batch Release)-Multi Level

    4 weeks ago

    Limerick, Limerick, Ireland Regeneron Ireland DAC Full time

    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: Preparing & reviewing of batch disposition documentation to support QP release of Formulated Drug Substance Reviewing of...

  • Qa Specialist-(Batch Release)-Multi Level

    5 days ago

    Limerick, Limerick, Ireland Regeneron Ireland Dac Full time

    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: Preparing & reviewing of batch disposition documentation to support QP release of Formulated Drug Substance Reviewing of...

  • Qa Specialist-(batch Release)-multi Level

    3 weeks ago

    Limerick, Limerick, Ireland Regeneron Ireland DAC Full time

    Performs activities in support of disposition of product while ensuring compliance with Quality Assurance (QA) policies and procedures, c GMPs, SOPs, and Regeneron Standard Requirement Documents.As a typical day may include the following: Preparing & reviewing of batch disposition documentation to support QP release of Formulated Drug Substance Reviewing of...

  • Regeneron QA Expertise in Batch Release

    2 days ago

    Limerick, Limerick, Ireland Regeneron Ireland Dac Full time

    Key ResponsibilitiesThis position involves a range of responsibilities that are focused on ensuring the quality of our products and processes. Some of the key responsibilities include:Batch Disposition and Review:Preparing and reviewing batch disposition documentation to support QP release of Formulated Drug Substance.Reviewing of QC related release data and...

  • Quality Assurance Specialist Batch Release

    2 days ago

    Limerick, Limerick, Ireland Regeneron Ireland Dac Full time

    Job DescriptionRole Summary: We are seeking a highly skilled Quality Assurance Specialist to join our team in Regeneron Ireland Dac. As a Quality Assurance Specialist, you will be responsible for ensuring the quality of our products by performing activities related to batch disposition, review of release data, documentation review, and more.Main...

  • Batch Release Professional

    6 days ago

    Limerick, Limerick, Ireland Regeneron Ireland DAC Full time

    Company Overview:Regeneron Ireland DAC is a world-leading biopharmaceutical company dedicated to discovering and developing innovative medicines that improve the lives of patients worldwide.Job Summary:We are seeking a talented Batch Release Professional to join our team, responsible for ensuring the quality and compliance of our products throughout the...

  • Multi-Level Product Specialist

    6 days ago

    Limerick, Limerick, Ireland Regeneron Ireland DAC Full time

    Multi-Level Product Specialist:This position involves ensuring the quality and compliance of our products throughout the manufacturing process.Key Responsibilities:Product Disposition: Perform activities in support of product disposition, ensuring compliance with Quality Assurance (QA) policies and procedures.Bulk Data Review: Review bulk data related to...

  • Senior Quality Assurance Professional Multi Level

    2 days ago

    Limerick, Limerick, Ireland Regeneron Ireland Dac Full time

    About This RoleWe are looking for a highly motivated Quality Assurance Specialist to join our team in Regeneron Ireland Dac. As a Quality Assurance Specialist, you will play a critical role in ensuring the quality of our products by performing activities related to batch disposition, review of release data, and documentation review.Main...

  • Batch Release and Regulatory Compliance Officer

    7 days ago

    Limerick, Limerick, Ireland Regeneron Full time

    Job Details">This role is responsible for supporting the batch release process and ensuring regulatory compliance in Regeneron's biologics manufacturing operations.About You">Degree or masters in a scientific field.At least 3 years of experience in biologics manufacturing operations.Excellent written, verbal, and interpersonal communication skills.Key...

  • Regeneron QA Expert

    6 days ago

    Limerick, Limerick, Ireland Regeneron Ireland DAC Full time

    Regeneron QA Expert:The ideal candidate will possess excellent organisational skills, attention to detail, and strong communication skills.Job Description:This role will involve performing activities in support of product disposition, reviewing batch records, and preparing deviation reports, change control, and batch record reports.Key...

  • Quality Assurance Specialist

    6 days ago

    Limerick, Limerick, Ireland Regeneron Ireland DAC Full time

    Job Description:We are seeking a highly skilled Quality Assurance Specialist to join our team at Regeneron Ireland DAC. As a key member of our quality assurance department, you will play a critical role in ensuring the compliance and quality of our products.Responsibilities:Disposition of Products: Perform activities in support of disposition of product...

  • Quality Assurance Specialist

    1 week ago

    Limerick, Limerick, Ireland Regeneron Ireland DAC Full time

    Company Overview">We are seeking a highly skilled QA Specialist to join our team at Regeneron Ireland DAC. As a QA Specialist, you will play a critical role in ensuring the quality and compliance of our biologics manufacturing operations.">Job Description">The QA Specialist will be responsible for performing activities in support of disposition of product...

  • QA Validation CSV Specialist-(Multi Level)

    4 weeks ago

    Limerick, Limerick, Ireland Regeneron Ireland DAC Full time

    Working under the Quality Assurance organization this position is responsible for ensuring IT systems, programs and quality events are robust and meet regulatory agency expectations. The position will liaise with the IT and broader QA organizations to ensure all aspects of IT related programs are in compliance with regulatory agency expectations and internal...

  • Qa Validation Csv Specialist-(Multi Level)

    1 week ago

    Limerick, Limerick, Ireland Regeneron Ireland Dac Full time

    Working under the Quality Assurance organization this position is responsible for ensuring IT systems, programs and quality events are robust and meet regulatory agency expectations.The position will liaise with the IT and broader QA organizations to ensure all aspects of IT related programs are in compliance with regulatory agency expectations and internal...

  • QA Validation CSV Specialist-(Multi Level)

    2 days ago

    Limerick, Limerick, Ireland Regeneron Full time

    Working under the Quality Assurance organization this position is responsible for ensuring IT systems, programs and quality events are robust and meet regulatory agency expectations. The position will liaise with the IT and broader QA organizations to ensure all aspects of IT related programs are in compliance with regulatory agency expectations and internal...

  • Qa Validation Csv Specialist-(multi Level)

    2 weeks ago

    Limerick, Limerick, Ireland Regeneron Ireland DAC Full time

    Working under the Quality Assurance organization this position is responsible for ensuring IT systems, programs and quality events are robust and meet regulatory agency expectations.The position will liaise with the IT and broader QA organizations to ensure all aspects of IT related programs are in compliance with regulatory agency expectations and internal...

  • Release and Quality Assurance Coordinator

    7 days ago

    Limerick, Limerick, Ireland Regeneron Full time

    Job Summary">This role is responsible for supporting the batch release process and ensuring regulatory compliance in Regeneron's biologics manufacturing operations.About the Role">Prepare and review batch disposition documentation to support QP release of formulated drug substance.Review QC-related release data and documentation.Complete deviation, change...

  • Biologics Manufacturing Operations Coordinator

    1 week ago

    Limerick, Limerick, Ireland Regeneron Ireland DAC Full time

    About the Role">The Biologics Manufacturing Operations Coordinator will work closely with our cross-functional teams to ensure the quality and compliance of our biologics manufacturing operations. This will involve preparing and reviewing batch disposition documentation, reviewing QC related release data, completing deviation, change control & batch record...

  • Mid-Level QA Engineer Position

    1 week ago

    Limerick, Limerick, Ireland Reperio Human Capital Ltd Full time

    Job Description"> We are seeking a mid-level QA Engineer who can contribute to both manual and automated testing in our Agile environment."> This role involves developing technical skills and progressing in one's career, working with a hybrid schedule of 2 days onsite."> The ideal candidate will have experience in a QA role, with 2-3 years of experience...

  • Senior QA

    4 weeks ago

    Limerick, Limerick, Ireland Eli Lilly and Company Full time

    At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities...