Job Description: The QA Technician at our Cork facility will provide QA support to a growing manufacturing site.
The incumbent performs material and product inspections and releases; documents the reviews and approvals, identifies, and communicates to management instances where materials or products are non-conforming with cGMP and QA standards.
This position will have the opportunity for cross-training in other areas of QA.
Key Duties & Responsibilities: Performs incoming AQL inspection on raw materials/finished goods/labels/ components according to written standard operating procedures, work instructions, and specifications Verifies and performs checks on cleaning processes as established in procedures pertaining to operation area before, during, and after production.
Complete associated logs Performs batch record review and approval as outlined to product specification Performs, monitors, and documents 1st article inspection and in-process checks in filling rooms in the operation area Verifies calibration and verifications on equipment logs in the operation area.
Reports reworks, deviations, product, and in-process issues to Quality management Works closely with manufacturing supervisors and leads to ensure collaborative problem solving as issues arise.
Will be required to be part of CAPA and RCA investigations.
Complies with ISO, cGMP, and other regulatory requirements.
Enforces adherence to requirements and performs regular trainings for QA technicians and production team leads to maintain continuous improvement focus.
Assists with the development of procedures and forms.
Assists with internal audits and problem-solving exercises when required.
Requirements: 12 months + QA experience essential.
Third level Science diploma or equivalent required.
Associates or Bachelors preferred.
Working knowledge of SAP, Master Control and Microsoft applications preferred.
Knowledge and experience with applicable regulation and cGMP requirements preferred.
Benefits: Private Health Insurance for employee and family on commencement of employment Gym subscription Life Assurance Bonus Free product each month 23 days holidays which increases with service Defined Contribution Pension Scheme Sick Pay Scheme for short and long term illness Educational Assistance Program