Process Technician

STERIS; Westport; On-site; EUR 34,000 - 55,000; Full time

Job summary

STERIS in Ireland is seeking a GMP/compliance minded QA/Process Assurance professional to support dosimetry release and documentation within our healthcare manufacturing environment. You will perform release reading, administer records, and support continuous improvement initiatives.

Applicants should have at least two years' GMP experience, good communication skills, and proficiency with MS Office. Training on ISO 13485 and customer-facing duties are part of the role.

Qualifications

• Two years or more of work in GMP environment.
• Good communication and interpersonal skills.
• Understanding and appreciation of GMP and ISO 13485.
• Experience in Healthcare manufacturing environment.
• Careful attention to detail and ability to follow procedures.
• Proficient with MS Office suite.
• Liaise with customers, operators, managers and STERIS.
• Motivate and coordinate team approach to continuous improvement and problem solving.

Responsibilities

• Perform dosimetry reading and release product within defined specification limits.
• Provide logistic information and customer support in response to queries by email or telephone.
• Prepare production administration paperwork including certificates, reports and shipping documents.
• Setup validation loads with dosimetry requirements per validation protocol.
• Setup Dose Audit as required by the customer.
• Collect dosimeters from routine and validation loads after processing.
• Maintain clean and orderly work areas to reflect GMP quality.
• Undertake other duties as assigned by Management.
• Provide operational support to the Manager when required.

Skills

Communication skills

GMP/ISO13485 knowledge

Healthcare manufacturing experience

Attention to detail

MS Office proficiency

Customer liaison

Teamwork and problem solving

Education

Vocational/Technical

Job description

Position Summary

• Verify product release by routine dosimetry.
• Preform all process assurance activities.
• Perform defined administrative duties regarding dosimetry and process records.
• Maintain all aspects of the process quality assurance system to achieve customer requirements consistent with STERIS policies.

Duties

• Perform dosimetry reading and release product within defined specification limits and follow documented procedures.
• Provide logistic information and customer support in response to customer query or request, received by email or telephone taking care of their needs in a timely, efficient and friendly manner.
• Prepare production administration paperwork including certificates of processing, dosimetry reports, letters, routine reports and shipping documents. Issue paperwork and follow up as necessary within limit of authority as specified by Management.
• Setup up validation load with dosimetry requirement as per validation department or customer validation protocol

Duties - cont'd

• Setup Dose Audit where required by customer
• Collecting dosimeters from routine and validation loads following processing during working hours and weekend where applicable.
• Reinforce impression of a quality G.M.P. Healthcare company by maintaining work areas clean and tidy.
• Undertake other duties, tasks and responsibilities as may be assigned by the Management from time to time.
• Provide operational support where required by Manager

Education Degree

Vocational/Technical

Required Experience

Two years or more of work in GMP environment.

Specific Work Requirements

• Good communication and interpersonal skills
• Understanding and appreciation of Good Manufacturing Practice and
• Quality Assurance programmes such as ISO 13485
• Experience in Healthcare manufacturing environment.
• Careful attention to detail. Ability to follow documented procedures.
• Proficient with MS Office suite
• Liaise with customers, operators, managers and STERIS
• Ability to motivate and co ordinate team approach to continuous improvement and problem solving

STERIS is a leading global provider of products and services that support patient care with an emphasis on infection prevention. WE HELP OUR CUSTOMERS CREATE A HEALTHIER AND SAFER WORLD by providing innovative healthcare and life sciences products and services around the globe. For more information, visit www.steris.com.

STERIS strives to be an Equal Opportunity Employer.