QC Analyst in the Quality Operations Laboratory
Location: South Tipperary
11 month contract role
I have an excellent contract opportunity for an experienced QC Analyst with 2+ years' pharmaceutical industry experience, performing analytical testing within a GMP lab.
As a QC Analyst, you will play a critical role in safeguarding product quality and regulatory compliance within our Quality Operations Laboratory. Using a broad range of analytical techniques including immunoassays, cell-based potency bioassays, HPLC, and compendial methods. You will perform and review both routine and non-routine testing to support product release and key project work. Reporting to the QC Manager, you will ensure objectives are consistently met in line with our commitment to compliance, safety, and a reliable supply for our customers.
Our Quality Control team is dedicated to upholding exceptionally high standards, ensuring that every material used in our products is manufactured, tested, packaged, stored, and distributed in full alignment with regulatory and corporate requirements. By partnering closely with internal manufacturing sites, external contract manufacturers, and suppliers, we support a truly global manufacturing network focused on delivering compliant, high-quality products to patients and customers on time, every time.
Roles and Responsibilities:
- Work under the direction of the QC Manager / Associate Director, in line with Company safety policies, cGMP and cGLP requirements.
- Drive compliance with Global policies, procedures, guidelines, and regulatory requirements, applying current Good Manufacturing Practices (cGMP) in all day-to-day activities and job functions.
- Develop, implement, and maintain procedures that meet applicable regulatory standards.
- Ensure full adherence to departmental Quality Systems on a daily basis.
- Actively contribute as part of the QC team, performing assigned testing and laboratory-based activities.
- Ensure the timely completion of all assigned data processing and data review activities.
- Complete Laboratory Investigation Reports and deviations within required timelines, following site procedures.
- Support the timely generation of trend data, investigations, nonconformances, validation protocols, and reports related to method validation/verification and equipment qualification.
- Participate in QC Tier 1 daily meetings, ensuring clear and effective communication of testing status, deviations, and issues.
- Perform peer review of testing documentation, ensuring data integrity compliance and achievement of QC Right First Time KPIs.
- Where applicable, review, approve, and trend analytical test results.
- Support and participate in the laboratory aspects of Out of Specification (OOS) investigations.
- Provide support during audits and inspections to maintain departmental compliance and inspection readiness.
- Participate in internal and external audits and inspections, acting as auditee for assigned areas of responsibility.
- Drive continuous improvement through root cause analysis of system failures and equipment performance issues, using standard problem-solving tools (e.g. FMEA, Fishbone diagrams, 5 Whys).
- Work collaboratively to promote and sustain a safe and compliant culture at the site.
- Carry out other duties as required.
Qualifications and Experience:
- Must have 2 years' pharmaceutical industry experience within Ireland.
- Bachelor's Degree or higher preferred, ideally in a science related discipline.
- Working knowledge of Irish, European, and international regulatory codes, standards, and practices.
- Solid understanding of current Good Manufacturing Practices (cGMP).
- Experience with or knowledge of Laboratory Quality Systems.
- Proficiency in Microsoft Office and relevant job-related computer applications.
- Strong report writing, standards development, and policy writing skills.
- Understanding of Lean Six Sigma methodologies is preferred.
- Immunoassay and cell culture experience is desirable.
