JT712 - SR. SPECIALIST QA

Quality Consulting Group • Juncos, PR

7d

About The Position

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.

Requirements

• Bachelor's degree in related area
• 6 years of directly related experience
• Experience in Commissioning and Qualification, Equipment validation, QRAES, Kneat, Good Documentation Practices, Change Controls, SOP’s etc
• Project management skills.
• Strong organizational skills, including ability to follow assignments through to completion.
• Strong knowledge of and experience with processes involved in manufacturing and distribution, QA, QAL, validation, and processes development.
• Demonstrated ability to interact with regulatory agencies.
• Strong word processing, presentation, database and spreadsheet application skills.
• Strong communication (both written and oral), facilitation and presentation skills.
• Advanced data trending and evaluation.
• Ability to evaluate compliance issues.

Responsibilities

• Approve process validation protocols and reports for mfg. processes.
• Represent Quality on incident triage team.
• Approve Environmental Characterization reports.
• Release of sanitary utility systems.
• Approve planned incidents.
• Represent QA on NPI team.
• Lead investigations.
• Own site quality program procedures.
• Designee for QA manager on local CCRB.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior