Laboratory Operator

JOB PURPOSE: To fulfil and complete the quality control functions of quality control, measurement, and document control functions within the production environment under GMP, GDP and QMS standards, supporting continuous improvement, customer requirements and regulatory compliance.

RESPONSIBILITIES:

·        Complete visual, functional and measurement (CMM, Vision System, Manual Gauges) inspections on production samples as per the defined sampling plans.

·        Ensure compliance with data integrity and record retention policies.

·        Timely and accurate reporting, analysis and communication of conforming/non-conforming product, visual defects, measurement trends and ‘Out of Spec’ results.

·        Aid in the resolution of customer complaints and non-conforming product

·        Aid in the timely release of in process product to the customer in accordance with policies, procedures and guidelines.

·        Correct storage of samples and maintenance of sample area

·        Assisting on and ensuring checkbacks are carried out as procedure.

·        Ensuring the shift is compliant with all MGS standards, processes & procedures, and reporting any non-conformances.

·        Ensure that the correct number of data/samples has been gathered as per requirements.

·        Assist during validation/engineering trials as required- accurate reporting, analysis and communication of results.

·        Assist metrology engineer on MSA/Gauge R&R.

·        Assist in training of associates for techniques and use of Metrology Lab equipment and supporting any training activities with their shift.

·        Maintaining a current and accurate record of works complete.

·        Ensure all shift paperwork is completed, GDP compliant and located/filed in the appropriate location.

·        Line clearance verification appointee for shift.

·        Pro-actively ensuring GMP, EHS and housekeeping standards are maintained throughout the MGS site.

·        Assist and support all continuous improvement activities to include but not limited to GMP, GDP, etc.

·        Proactively engage in continuous professional development.

·        Ensure adherence to company safety rules, SOPs, and QMS policies.

·        proactively maintain GMP, GDP, EHS, and housekeeping standards across laboratory and production environments.

·        Support and participate in internal and external audits, CAPA activities, and non-conformance investigations.

·        Assist in continuous improvement initiatives within quality, metrology, and documentation processes.

·        Train operators and team members on measurement techniques, metrology equipment use, and documentation practices.

·        Collaborate with cross-functional teams to resolve customer complaints and quality issues efficiently.

The above list of duties and responsibilities is not exhaustive, and the role holder may be required to carry out other duties which may reasonably be assigned by management.

THE IDEAL CANDIDATE WILL:

·        Have previous experience working in a GMP compliant environment.

·        Possess excellent verbal and written communication skills.

·        Have strong information management and analytical skills.

·        Have the ability to multitask in a fast-paced environment.

·        Be proficient in MS Office and standard laboratory information management systems.

·        Have previous experience working in a quality control/assurance role and/or in a laboratory setting.

·        Knowledge of dimensional measurement software (MeasureMind) and metrology principles.

·        Strong data analysis, information management, and problem-solving skills.

·        Team player with the ability to work independently and take initiative.

Qualifications, Education, Experience, and Training 

·        A high school diploma or equivalent is required. Students with a background in quality engineering, metrology, or a related technical field are preferred.

·        2-4 years of experience in quality control/assurance, metrology, or document control in a GMP-regulated environment, such as a medical device or high-precision manufacturing company.

·        Prior training in GMP, GDP, and QMS practices; dimensional measurement systems (CMM, vision systems, and Keyence); and document control systems.

·        Training in the interpretation of 2D drawings and GD&T is preferred.

·        Experience using MeasureMind and laboratory information management systems. Advanced skills in Microsoft Office (Excel, Word, and PowerPoint) are required.

·        English B2 Intermediate.