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. Associate’s or Bachelor’s 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
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