Senior QC Lab Analyst (Micro)
AbbVie
Company Description
AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas – immunology, oncology, neuroscience, and eye care – and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on X, Facebook, Instagram, YouTube, LinkedIn and Tik Tok.
Job Description
We don’t just stand for science. We elevate it.
Science is at the heart of what we do. People are at the heart of why we do it.
We are now recruiting a Senior QC Laboratory Analyst (Microbiology) to join our diverse QC Microbiology team in Westport, Co. Mayo. In this role you will be responsible for delivering training as required for Microbiology, undertaking administration of compliance wire and maintaining training levels for all lab personnel. You will also ensure compliance is adhered to within the microbiology laboratory and review compendial chapters for changes and vendor notifications related to compliance.
You will also have the opportunity to manage transition year students and new hires within the lab.
So let’s tell you a little more about this role…
In this role you will:
- Fulfil lab training requirements with training sessions for Induction for new hires, documentation review training sessions and other tests within microbiology
- Carry out Compliance wire administrator role and monitor overdue items
- Maintain training records within the lab/ Custodian of Documentation, file closed logbooks/folders and track triwalls
- Schedule and supervise Transition year students within the lab
- Organise external and internal training as required for lab personnel
- Focus on improving the causes of delays to close GTW records through the GTW meeting to ensure they are closed in a timely manner
- Hold monthly change control meetings to drive delivery of these changes
- Review updates of pharmacopeias/regulatory guidelines
- Act as a first point of contact for supplier notifications, attendance at monthly meetings, generated C.C to update changes
- Vendor notifications representative: Audit readiness coordinator, point person during audits and gather info requested by the quality team before audit starts
- Root cause assessment facilitator for repeat/Major CAPA, leading to the generating of appropriate corrective/preventative actions to eliminate/reduce future non-conformances
- Adhere to all company standards in the areas of safety, housekeeping and quality, notifying management of any discrepancies
- Work with a team of Supervisors, Quality Manager and Laboratory Manager to ensure compliance to Quality Management System
- Ensure all activities are carried out in compliance with product license commitments, cGMP and legislative regarding health, safety and environment.
Qualifications
- 3rd Level Qualification in Microbiology or equivalent scientific degree
- Minimum of 12 months working in a Microbiology Laboratory environment is required
- Working knowledge of both Pharmaceutical Industry and sterile processing
- Strong background in Microbiology
- Experience in training team members
- Experience in performing routine and non-routine Microbiological testing activities
- Has a knowledge of pharmacopoeia and compendial chapters relating to microbiology.
Additional Information
AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled.
US & Puerto Rico only - to learn more, visit https://www.abbvie.com/join-us/equal-employment-opportunity-employer.html
US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more:
https://www.abbvie.com/join-us/reasonable-accommodations.html