Basic Role Summary:
In this role, you will carry out analytical testing on finished products (release and stability) and raw materials using approved procedures to ensure compliance with GMP, Health and Safety, SOPs, and environmental and regulatory requirements while meeting customer needs. The role also provides technical support to the QC function as required by management.
Location: Onsite at our facility in Loughrea.
As our Senior QC Analyst, your key responsibilities will be as follows:
Perform analytical testing of finished products, stability samples, raw materials, and contract manufactured products in line with approved methods and customer specifications.
Demonstrate and maintain competency in HPLC, IR, UV, dissolution, and physical testing techniques.
Follow all relevant SOPs, pharmacopoeial methods, specifications, regulatory requirements, and industry standards.
Complete incoming inspection of foils, labels, bulk finished goods, and injectables.
Support laboratory testing schedules to maintain an efficient QC system and customer service level greater than 95%.
Calibrate and maintain laboratory equipment in accordance with approved calibration procedures.
Maintain laboratory logbooks, notebooks, and associated documentation in compliance with GLP requirements.
Liaise with Team Leaders, Supervisors, and Production to ensure timely reporting of analytical results.
Provide timely feedback on analytical queries and testing outcomes.
Escalate discrepancies, deviations, and non‑conformances to the appropriate supervisory personnel.
Review OOS and LIR investigations, providing technical input to ensure timely closure.
Support and follow up on corrective actions.
Participate in internal and external audits as required.
Liaise with external suppliers and vendors regarding QC consumables.
Support continuous improvement by ensuring quality procedures are followed and by raising change controls where appropriate.
Adhere to agreed internal laboratory rota tasks.
Maintain high standards of housekeeping, hygiene, and laboratory safety at all times.
Ensure QC records are accurate, complete, and properly filed.
Work collaboratively within the QC team, demonstrating flexibility, structured work practices, and willingness to support colleagues.
Carry out any other duties assigned by the Supervisor or Manager.
Qualifications and Experience:
Bachelor’s degree in a chemistry‑based discipline.
5+ years’ experience in a Senior QC Analyst or QC Analyst role.
Experience working within a pharmaceutical cGLP environment with knowledge of EU GMP and US FDA guidelines.
Strong computer skills in Microsoft Office.
Skills and Competencies:
High level of technical competency in HPLC, IR, UV, dissolution, and physical testing.
Strong attention to detail with a compliance‑focused mindset.
Effective verbal and written communication skills.
Ability to work in a methodical, systematic, and structured manner.
High ethical standards with appropriate issue escalation.
Flexible, proactive approach with a willingness to further develop technical expertise.
Strong collaboration skills and positive contribution to team culture.
Applicants from diverse backgrounds, including those returning after a career break or with transferable skills from non‑traditional career paths, are encouraged to apply. We value varied experiences and are committed to fostering an inclusive environment that supports individuals with disabilities.
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