JT713 - SR. SPECIALIST QA

Quality Consulting Group, LLC; Juncos (PR); On-site; USD 80,000 - 110,000; Full time

Job summary

Quality Consulting Group, LLC in Puerto Rico and across the USA is seeking a talented QA professional to join our team. You will contribute to a world-class manufacturing operation by approving validation protocols and reports, leading investigations, and representing QA on incident triage and NPI teams.

The ideal candidate holds a Bachelor's degree with 6 years of directly related experience, with strong CSV, GDP, risk management, and change control knowledge, plus hands-on experience with Q&As

Qualifications

• Bachelor's degree required with at least 6 years of related experience.
• Experience with Facilities and Utilities Commissioning and Qualification (C&Q).
• Knowledge of Computer System Validation (CSV).
• Experience with Equipment Validation.
• Experience with risk-based methodologies and risk assessments.
• Proficient with GDP and data integrity principles.
• Experience with Change Control processes.
• Experience developing and updating SOPs.
• Experience with Syringe and Vial Inspection Processes.
• Experience with Document Revision and Approval processes.
• Knowledge of Decision-Making Techniques and Risk Management.

Responsibilities

• Approve process validation protocols and reports for manufacturing 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.
• Project management skills.
• Strong knowledge of manufacturing, QA, QAL, validation, and processes development.

Skills

QA expertise

Process validation

Risk assessment

Data integrity

Decision making

Education

Bachelor's degree + 6 years experience

Tools

KNEAT

C-DOCS

SCADA

TrackWise

Maximo

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.
• Project management skills.
• Strong knowledge of and experience with processes involved in manufacturing and distribution, QA, QAL, validation, and processes development.

Qualifications

• Bachelor's degree and 6 yearsof directly related experience
• Experience with Facilities and Utilities Commissioning and Qualification (C&Q).
• Knowledge and experience in Computer System Validation (CSV).
• Experience with Equipment Validation.
• Experience conducting Risk Assessments and applying risk-based methodologies.
• Proficiency with systems and platforms such as KNEAT, C-DOCS, SCADA, TrackWise, and Maximo.
• Strong knowledge of Good Documentation Practices (GDP) and Data Integrity principles.
• Experience with Change Control processes.
• Knowledge and experience developing, reviewing, and updating Standard Operating Procedures (SOPs).
• Experience with Syringe and Vial Inspection Processes.
• Experience with Document Revision and Approval processes.
• Strong knowledge of Decision-Making Techniques.
• Strong knowledge of Risk Management principles and practices.
• Ability to assess risks, analyze complex situations, and make sound decisions in accordance with applicable procedures, quality standards, and regulatory requirements.

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.