QA Specialist-(Batch Release)-Multi Level

2 days ago

Dublin, Ireland QA Full time

QA Specialist-(Batch Release)-Multi Level Mid-Senior level Not disclosed Ireland Limerick, County Limerick, Ireland
15 days ago
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 is essential
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 have the ability to 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 experience 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.

#J-18808-Ljbffr

  • QA Operations Specialist

    1 week ago

    Dublin Pike, Ireland QA Full time

    Mid-Senior level Not discloses Ireland Dublin, County Dublin, Ireland 20 hours ago The role: PE Global is currently recruiting for a QA Operations Specialist on behalf of a leading biotech company based in Dublin North. This is an initial 11-month contract and a 4 cycle shift position. • Shift will be 4 days on, 4 days off with 12 Hour Shifts (7am -...

  • Senior QA

    1 week ago

    Dublin Pike, Ireland QA Full time

    at Archer - The IT Recruitment Consultancy Mid-Senior level Not disclosed Ireland Dublin, County Dublin, Ireland 29 days ago Job Title: Senior QA Engineer (Manual Testing) – Contract €400-450/Day Location: Dublin Contract Length: 6 months (high potential for extension) Join a Global Leader in Insurance & Technology An exciting opportunity awaits an...

  • Senior Qa

    3 weeks ago

    Dublin, Ireland Qa Full time

    at Archer - The IT Recruitment ConsultancyMid-Senior level Not disclosed Ireland Dublin, County Dublin, Ireland29 days agoJob Title: Senior QA Engineer (Manual Testing) – Contract €400-450/DayLocation: DublinContract Length: 6 months (high potential for extension)Join a Global Leader in Insurance & TechnologyAn exciting opportunity awaits an experienced...

  • QA Specialist

    3 weeks ago

    Dublin, Dublin City, Ireland HRM Full time

    Recruitment Consultant - Contracting ServicesThis organisation is a manufacturer, marketer, and distributor of veterinary pharmaceuticals and animal health products.ResponsibilitiesQuality System ManagementImplement, maintain, and improve the Quality Management System (QMS) in accordance with GMP (Good Manufacturing Practices), VICH, FDA (21 CFR Part...

  • QA Operations Specialist

    3 weeks ago

    Dublin, Dublin City, Ireland PSC Biotech® Corporation Full time

    OverviewThe Quality Specialist provides direct Quality support to a production area as part of a Quality IPT (Integrated Product Team). With guidance from the Associate Director of Quality Operations, the Quality Specialist ensures quality and compliance of products manufactured by the functional area, adherence to Good Manufacturing and Documentation...

  • Senior Specialist, Sterile Drug Product, QA Manufacturing Operations

    4 weeks ago

    Dublin, Dublin City, Ireland Bristol Myers Squibb Full time

    Senior Specialist, Sterile Drug Product, QA Manufacturing OperationsProvide QA oversight for Sterile Drug Product operations during start-up and commercial manufacturing, including readiness for 24/5 operations, tech transfer, and ongoing QA activities for release and investigations.The RoleBMS Cruiserath Biologics is seeking to recruit a Senior Specialist,...

  • Apply Now: QA Specialist

    2 days ago

    Dublin Pike, Ireland QCS Staffing Full time

    Overview QA Specialist - Ireland, Dublin - 6 Months Initial Contract Are you a QA Specialist wanting to join an international team working to improve healthcare? Our client is a global health care company specializing in delivering lifesaving medicines worldwide. They are looking for a QA Specialist to join their team. Responsibilities Reviewing and...

  • QA Specialist

    1 week ago

    Dublin, Ireland Quanta Consultancy Services Ltd Full time

    QA Specialist - Dublin, Ireland - 12 Months Contract One of the top 10 best companies to work in Ireland is looking for QA Specialistfor their large-scale new facility in Dublin. Is this you? An exciting project there is lots of opportunity to learn new technology and develop current skills within a fast paced €1 billion project. This fantastic client...

  • Qa Specialist

    4 weeks ago

    Dublin, Dublin City, Ireland Quanta Consultancy Services Ltd Full time

    QA Specialist - Dublin, Ireland - 12 Months ContractOne of the top 10 best companies to work in Ireland is looking for QA Specialistfor their large-scale new facility in Dublin.Is this you?An exciting project there is lots of opportunity to learn new technology and develop current skills within a fast paced €1 billion project.This fantastic client offers...

  • Quality Assurance Specialist

    4 weeks ago

    Dublin, Dublin City, Ireland Steripack Full time

    Quality Assurance Specialist – External Quality VaccinesLocation:Dublin| Contract: Fixed-term (Maternity Cover)Join a global biopharmaceutical leader as a Quality Assurance Specialist overseeing vaccine manufacturing with external partners. Acting as Product Quality Manager, you'll ensure GMP-compliant production, batch release, quality oversight, and...