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Quality Consulting Group

JT713 - SR. SPECIALIST QA

Quality Consulting Group Juncos, Puerto Rico, United States

Outsourcing and Offshoring Consulting · 51-200 employees

20 h ago
qa Senior (5-10 yrs) Contractor United States
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About the role

The Senior Specialist QA will approve process validation protocols, lead investigations, and represent Quality on incident triage and NPI teams. They are also responsible for owning site quality program procedures and acting as a designee for the QA manager on the local CCRB.

What they look for

Process Validation Quality Assurance Incident Triage Environmental Characterization Project Management Computer System Validation Equipment Validation Risk Assessment Good Documentation Practices Data Integrity Change Control Standard Operating Procedures Syringe Inspection Vial Inspection Decision-Making Techniques Risk Management

Requirements

Candidates must hold a bachelor's degree and possess at least 6 years of directly related experience in manufacturing and quality assurance. Proficiency in systems like KNEAT, TrackWise, and Maximo, along with strong knowledge of CSV, C&Q, and regulatory standards, is required.

Full description

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:  

  • 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 years of 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.

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