QC Analyst

Orion Group Life Sciences are currently recruiting a QC Analyst on behalf of our Multinational Biopharmaceutical Client based in Carlow on an initial 11-Month contract with potential to extend. Site Based Shift Role.

Week 1: Mon 7:00 - 17:00 Tues 7:00 - 17:00 Wed Off Thurs Off Fri 7;00 - 17:00 Sat 7:00 -19:00 or 9:00 - 21:00 (alternate as agreed between shift mates) Sun 7;00 - 19:00 or 9:00 - 21:00 (alternate as agreed between shift mates)
Week 2: Mon Off Tues Off Wed 7;00 - 19:00 Thurs 7:00 - 19:00 Fri Off Sat Off Sun Off

Key Accountabilities:

• Comply with and execute CGMP/GDP in the performance of day-to-day business activities.
• Ensure data integrity principles: Attributable, Legible, Contemporaneous, Original, and Accurate (ALCOA) are adhered to for records and data in day-to-day business activities.
• Attend and successfully complete applicable CGMP training.
• Escalate any potential violation of CGMP and/or other concerns which may affect the safety, efficacy, quality, or purity of MMD human health products.
• Work collaboratively to ensure a safe and compliant culture in Carlow.
• Participate in driving a high performing & inclusive culture, stimulating personal growth & development.
• May be required to perform other duties as assigned Ensure that adequate processes and procedures are in place and followed for all Quality activities.
• Where required work shift patterns in line with manufacturing operations to ensure Quality operations (including testing, delivery and or oversight) as required as per business needs & if needed.
• Provide support to the relevant support functions to ensure manufacturing and release of vaccine and biologic products activities, in compliance with applicable procedures, our Company’s Global Policies and Guidelines, regulatory requirements and current Good Manufacturing Practices (cGMP).
• Develop and maintain effective cross-functional relationships with other departments and support functions to ensure that the process for the manufacturing,, testing and release of vaccine and biologic products are in compliance with cGMP and the associated regulatory requirements.
• Identify and support compliance initiatives to improve compliance status and overall operational efficiency for batch release at the site.
• Support business critical projects related to the Quality Department.
• Perform laboratory testing and / or materials inspections to determine specification conformance.
• Perform all required analytical, microbiological and control testing to support the site.
• Maintain an adequate, qualified and compliant laboratory environment to conduct testing while adhering to appropriate PPE and safety requirements.

Education

• Bachelor’s Degree or higher preferred; ideally in a related Science discipline

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Orion Group was founded in 1987 and is now one of the largest, independent, international recruitment companies. We have a network of 200 employees working from 24 offices, delivering a range of services – Talent Acquisition, Recruitment Outsourcing Services, Retained Search, Global Workforce Solutions, Completions & Commissioning and Materials Management – across 68 countries. As a global leader in workforce solutions, we recruit personnel across the Engineering & Technical, Office & Commercial, Scientific and Skilled Trades disciplines, for sectors including Oil & Gas, Life Science, Power & Utilities, Constructions & Infrastructure, Manufacturing and Renewables.