JT100 - SPECIALIST QA

Juncos, Puerto Rico

Contracted

Biopharmaceutical

Experienced

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:

Perform Trackwise system queries, deviations
Participate in triage process
Perform oversight of the process and procedures/GMP tasks
Manage Change Controls and deviations for review and approval as QA contact
Work with operations to resolve basic compliance discrepancies
Approve process validation protocols and reports for manufacturing processes.
Request Quality on incident triage team.
Approve Environmental Characterization reports.
Release of sanitary utility systems.
Approve planned incidents.
Represent QA on NPI team.
Lead investigations.
Lead site audits.
Own site quality program procedures.
Designee for QA manager on local CCRB.
Review Risk Assessments.
Support Automation activities.
Support facilities and environmental programs.
Review and approve Work Orders.
Review and approve EMS/BMS alarms.
Approve NC investigations and CAPA records.
Approve change controls.
Provide lot disposition and authorize lots for shipment.

Qualifications:

Bachelor's degree in Life Science and/or Engineering.
5 years of directly related experience
Knowledge in Validations and Laboratory area and equipment
Strong organizational skills, including ability to follow assignments through to completion.
Enhanced skills in leading, influencing and negotiating with the ability to interact with regulatory agencies and evaluate compliance issues.
Microsoft Office spreadsheet and application skills and presentation knowledge.
Strong communication (both written and oral), facilitation and presentation skills. Fully Bilingual in English and Spanish.
Validated skill in working independently and to optimally interact with all levels throughout the organization.
Available for administrative 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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