Quality Assurance Associate

4 days ago

Dublin, Dublin City, Ireland beBeeQuality Full time €40,000 - €60,000
Job Title: Quality Assurance Specialist

The Quality Assurance Specialist will be responsible for ensuring the quality and integrity of our manufacturing operations. This is a key role within our site QA team, reporting to a Senior QA Manager.

Responsibilities:

  • Perform all activities in compliance with Amgen safety standards and standard operating procedures.
  • Observe and provide real-time quality oversight and support for manufacturing on the floor.
  • Perform purposeful presence on the floor audits.
  • Perform manual pack check and DFT assessment
  • Perform Batch Review to support customer complaint investigations
  • Provide quality support for triage and investigation of all classes of deviation events.
  • Review/approve deviations for closure ensuring compliance with appropriate standards.
  • Review/approve production batch records, and associated documentation in preparation for qualified person disposition activities.
  • Provides training and advice to staff in order for them to perform their desired functions.
  • Write, review and approve Standard Operating Procedures in accordance with Amgen policies.
  • Support continuous improvement and operational excellence initiatives
  • Any other tasks/projects assigned as per manager's request.

Requirements:

  • Strong attention to detail in terms of task execution and QA review.
  • Proven in Risk Based Decision Making – ability to assess both the impact of an event that occurs and the suggested path-forward.
  • Excellent written and verbal communication skills – ability to communicate across different teams/backgrounds & up/down different levels with the organisation.
  • Strong organisational skills, including ability to follow assignments through to completion – ability to work well on own and as part of a dynamic team.
  • Knowledge of applicable Regulatory requirements, and ability to evaluate compliance issues
  • Operational Excellence / Continuous improvement experience – ability to identify areas for improvement & implement said improvements.
  • Problem solver
  • Advising and finding a compliant path forward
  • Previous Production experience
  • Ability to do shift role 24/5 (at the moment shift schedule can change according to business needs, notice will of course be provided of any change to cycle)

Qualifications:

  • Degree in a relevant field (e.g. Science, Engineering, etc.)
  • Relevant industry certifications or qualifications (e.g. ISO, GMP, etc.)

At our company, we pride ourselves on providing a collaborative and supportive environment that fosters growth and development. We are committed to helping our employees achieve their full potential, while delivering high-quality products to our customers.

  • Senior Quality Assurance Associate

    4 days ago

    Dublin, Dublin City, Ireland PE Global Full time

    Senior Recruitment Consultant @ PE GlobalDescription:PE Global is currently recruiting for a Senior QA Associate on behalf of a leading biotech company based in Dublin South. This is an initial 12-month contract role.This is a shift position. The shift patterns are as follows: 07:00 to 19:00, and 19:00 to 07:00. (4 on, 4 off).OverviewThe Plant Quality...

  • Quality Assurance Associate

    4 days ago

    Dublin, Dublin City, Ireland Next Generation Full time

    OverviewMy client is seeking a Quality Assurance Associate (QMS) to support the development and maintenance of the company's Pharmaceutical Quality System. This role will focus on the day-to-day processing of change controls and the generation and communication of Change Control KPIs. It will also involve managing key quality system elements including...

  • Senior Quality Assurance Associate

    5 days ago

    Dublin, Dublin City, Ireland beBeeQualityAssurance Full time €60,000 - €75,000

    Job Title: Senior Quality Assurance AssociateWe are currently seeking a skilled Senior Quality Assurance Associate to join our team. As a key member of the quality control department, you will be responsible for planning and performing multiple complex routine/non-routine methods and procedures.Key Responsibilities:Plan and perform analyses with great...

  • Quality Assurance Associate

    4 days ago

    Dublin, Dublin City, Ireland beBeeCustomerSupport Full time €45,000 - €60,000

    As a Quality Assurance Associate, you will be responsible for delivering exceptional customer service and technical support to resolve complex issues in a timely manner.Main Responsibilities:Provide technical assistance to customers via various channelsFoster collaboration with cross-functional teams to ensure prompt issue resolutionMaintain accurate...

  • EMEA Quality Assurance Associate

    5 days ago

    Dublin, Dublin City, Ireland JPMorgan Chase & Co. Full time

    EMEA Quality Assurance Associate - Monitoring and TestingJob Description Join thepliance, Conduct & Operational Risk (CCOR) Quality Assurance Monitoring and Testing (M&T) team as a Quality Associate. As part of Risk Management andpliance, you are at the center of keeping JPMorgan Chase strong and resilient. You help the firm grow its business in a...

  • Quality Assurance Specialist

    3 days ago

    Dublin, Dublin City, Ireland beBeequality Full time €45,000 - €70,000

    Job Title: Quality Assurance SpecialistThe company is seeking a dedicated Quality Assurance Associate to join their team. As a Quality Assurance Associate, you will play a key role in ensuring the quality of products and services.",

  • Clinical Quality Assurance Associate

    4 weeks ago

    Dublin, Dublin City, Ireland WEP Clinical Full time

    Are you looking for an exciting and fulfilling new position? Join our dynamic team at WEP Clinical, where your contributions will play a key role in driving impactful solutions and improving outcomes for clients and patients. We encourage innovation and collaboration, challenging our team to bring forward ideas that make a real difference. Be part of a...

  • QA Senior Associate

    5 days ago

    Dublin, Dublin City, Ireland beBeeQuality Full time €72,920 - €99,105

    Life Science Consultants are seeking a skilled QA Senior Associate to fill key roles. This is an exciting opportunity for experienced professionals to contribute their expertise in quality assurance and regulatory compliance.Key ResponsibilitiesReview and approve production batch records and associated documentation for Qualified Person disposition...

  • EMEA Quality Assurance Associate – Monitoring and Testing

    4 weeks ago

    Dublin, Dublin City, Ireland JPMorganChase Full time

    EMEA Quality Assurance Associate – Monitoring and Testing2 days ago Be among the first 25 applicantsGet AI-powered advice on this job and more exclusive features.Job DescriptionJoin the Compliance, Conduct & Operational Risk (CCOR) Quality Assurance Monitoring and Testing (M&T) team as a Quality Associate.As part of Risk Management and Compliance, you are...

  • Quality Assurance Specialist

    4 days ago

    Dublin, Dublin City, Ireland beBeeQuality Full time €60,000 - €80,000

    Job Overview">The Plant Quality Assurance (QA) Senior Associate is a key member of the site QA team, reporting to a Senior QA Manager. This role involves serving as the quality point of contact for manufacturing operations, with a focus on ensuring compliance with Amgen safety standards and standard operating procedures.">Responsibilities:">Perform all...