Purpose
Purpose This role will be part of our Testing Self-Directed work team in our state of the art single use multi-product biotech facility in Dunboyne. The QC Analyst will work across the site self-directed work teams and hub teams to identify and resolve issues in order to allow the site to deliver on our commit culture that support Quality, EHS, Learning and Continuous improvement. The QC Analyst will be responsible for functional testing of in-process drug substance/drug product, final and drug products, and stability samples at the new single use multi-product biotech facility. The overall responsibility for this role will be to support the Quality Control testing function related to Biochemistry and Cell Biology methods, ensuring compliance with cGMP and corporate regulations. This is a critical role within the Quality organisation to help establish the Laboratories as a hub for specialised analytical testing and create value for our patients.
Responsibilities
Perform a variety of routine Biochemistry and Cell Biology analytical testing techniques and associated documentation; including but not limited to ELISA, PCR, Bioassays and Cell Culture, water and cleaning validation sample testing and compendial methods in compliance with GMP requirements.
Review and approve Analytical Testing data.
Support activities including general lab readiness, audit readiness, laboratory equipment qualification and analytical method technical transfer, verification and validation.
Get actively involved by participating in inspections, GEMBA's and Go-See's.
Complete COMMIT cards to highlight ways of working within our SDWT's and Hubs across our site that support our COMMIT culture.
Know the hazards of the tasks you are performing, actively conduct risk assessments for inclusion into operational SOPs.
Challenge and identify improvements to the safety and environmental programmes on site.
Be a visible leader of safety initiatives and stay actively involved in safety forums.
Be part of a motivated and high performing team.
Lead approved projects and continuous improvement initiatives that are in alignment with the site strategies.
Undertake job specific activities:
Undertake job specific activities:
On-time completion for one's own training and to continue professional development and generate expertise in the role.
Ensuring strict adherence to site policies, GMP and environmental, health and safety regulations, compliance with regulatory authority requirements.
Participate in walk-downs of labs.
Engage in investigations and review of deviations.
Mentor/train new members of staff in specific lab activities.
Assist in project activities as they arise to maintain and optimise the facility.
Testing of all laboratory samples including in-process and developmental samples, product validation, stability testing.
Performance of laboratory tests as per written procedure or as per pharmacopoeia.
Recording of analytical results accurately.
To act as an end-user for testing input and process changes.
Operation, qualification, maintenance, calibration, and troubleshooting of laboratory instruments.
Preparation and execution of instrument and method validation protocols.
To maintain written training records.
To ensure that the laboratory is kept clean, tidy and safe always.
To report any non-conformance, instrument malfunction, accident or other abnormal occurrence to immediate superior.
Ordering, receiving and controlling laboratory chemicals, reagents and consumables.
Receiving and controlling test samples.
Reviewing data, reports, and performing peer reviews to ensure compliance with standards; reports any quality anomalies.
Following all relevant Standard Operating Procedures.
Ensures new/revised quality system requirements are deployed to the site.
Observe GLP/cGMP always.
Qualifications
A degree qualification in Science/Quality/Technical (or related).
GMP laboratory experience in the biotechnology and/or pharmaceutical industry, preferably in relation to ELISA, PCR, or Bioassay Analytical Testing.
Preferably Lean Six Sigma experience.
Excellent written and oral communication skills.
An understanding of cGMP requirements for manufacturing and/or systems and compliance.
Required to work on his/her own initiative in a constructive manner in addition to working as part of a team.
Proven ability through working across teams focusing on meeting and tracking to schedules and embracing and interdependent work culture as an agile team member.
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