JT712 - SR. SPECIALIST QA

Quality Consulting Group, LLC; Juncos (PR); On-site; USD 90,000 - 130,000; Full time

Job summary

Quality Consulting Group, LLC is seeking a highly motivated QA professional to join our team in a world-class manufacturing environment in Puerto Rico and the USA. You will oversee process validation, QA representation on incident triage and NPI teams, and drive investigation-led improvements across site quality programs.

Ideal candidates bring 6+ years of relevant experience, strong regulatory interaction skills, and a track record of equipment validation, QRAES, Kneat, Change Controls, and

Qualifications

• Bachelor's degree in a related area required.
• 6 years of directly related experience.
• Experience in commissioning and qualification, equipment validation, QRAES, Kneat, GxP documentation, Change Controls, and SOPs.
• Strong organizational skills and ability to follow assignments through to completion.
• Experience interacting with regulatory agencies.
• Excellent written and verbal communication, and data evaluation abilities.

Responsibilities

• Approve process validation protocols and reports for manufacturing processes.
• Represent QA 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.

Skills

Project management

Organizational skills

Communication

Data trending & analysis

Regulatory interaction

Education

Bachelor's degree in related area

Tools

Kneat

QRAES

Change controls

Job description

QUALITY CONSULTING GROUP, a leader inthe 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:

• 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.

Qualifications:

• Bachelor's degree in related area
• 6 yearsof 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.

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.