JT692 - QUALITY ASSOCIATE II

Guaynabo, Puerto Rico

Temporary

Medical Device

Mid Level

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:

Providing Quality support and oversight via direct staff supervision or process/area responsibilities.
Microbiology Investigations and daily sampling
Identify and assess regulatory and quality risks in activities and processes according to regulatory agency rules and guidelines and quality practices.
Leads ongoing, daily departmental operations.
Interview/hire, evaluate, train and develop direct reports Perform in-depth internal assessments and evaluations by collecting and analyzing accurate, objective evidence regarding risks and their magnitude.
Develop plans to correct identified risks including areas of non-conformance, inform management and implement approved corrective action plans.
Write, review, analyze and revise written Standard Operating Procedures (SOPs) and submit procedural changes as needed to meet Corporate, Divisional, Plant, Regulatory Requirements, etc.
Support external assessments or audits.
Assist with audits of various reports (Protocols, Qualifications, Regulatory Submissions, etc.)
Serve as Subject matter Expert (SME) and provide training to local employees as needed on relevant area(s) Other duties, tasks or projects as assigned.

Qualifications:

Associate degree in science/scientific discipline (Biology, Microbiology preferred)
1-3 (one to three) years of relevant.
Experience in Medical device industry preferred
Strong interpersonal skills and great attention to detail are necessary.
Must be a strong team player with good problem solving, and good verbal and written communication skills.
Must have the ability to manage people, encourage teamwork and drive decisions.
Must be able to handle multiple projects concurrently, have computer experience and have knowledge of FDA Regulations, Application of Good Laboratory Practices, and Application of Good Manufacturing Practices as appropriate.
Part time (20 to 24 hours weekly)
1st shift

Quality Consulting Group, LLC is an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, protected veteran status, disability status, or any other characteristic protected by law.

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