JT809 - Quality Associate I

QUALITY CONSULTING GROUP, a leader in the pharmaceutical, biotech, medical devices, and manufacturing industry, is looking for a talented, highly motivated and enthusiastic to join our team. In this role, you’ll work with a highly enthusiastic team, contributing in a world-class manufacturing industry in Puerto Rico & USA.

Responsibilities:

• Revise and approve all documentation related to the areas of responsibilities such as: In Process Checker Charts, Product Retention Records, Control Charts, Mold Approvals, Batch Records related and others.
• Responsible for routine manufacturing audits of machine parameter and/or set-ups for compliance as well as the product manufactured.
• Perform routine audits of sampling techniques testing skills ­­­­and all documentation performed by the TIQ's.
• Responsible for an immediate notification and awareness to Quality Management of potential Quality situations.
• Provide training as required on: Good Documentation Practices, SPC, Total Integrated Quality and others.
• Provide support regarding mold approval and mold start up evaluations (if applied).
• Gather, analyze, audit and interpret data using SPC methods so as to be able to predict trends and recommend process improvements that would impact favorably on product quality, scrap reduction, DPM reduction, Complaints reduction, price of non-conformance reduction and others. Maintains, revise and audits control chart and compute control chart limits as required.
• Insure that all machinery, equipment, tools or any other measuring, monitoring material complies with Corporate, GMP and other regulatory requirements.

Qualifications: 

• BD Science with experience working with Quality processes in MFG or medical device industry.
• Two (2) years of Previous experience
• Knowledge in Data Entry – Microsoft Office Software.
• Basic computer knowledge is required Experience in measurements instrumentation. Good interpersonal skills. 
• Willing to travel occasionally.
• Availability for 3rd shift 
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