Senior Specialist QA ProQN713

Job Description

Job Description

Title: Senior Specialist QA

Location: Juncos, PR — Open only to Puerto Rico Residents

Work Schedule: Onsite | Administrative Shift

Contract Duration: 1 Year

Positions Available: 1

Summary

Our client is seeking a Senior Specialist QA to serve as a technical Quality Assurance specialist supporting manufacturing and quality operations. The selected professional will review and approve manufacturing documents and product MPs, provide QA support for quality events and new product introduction activities, lead investigations, and support compliance across manufacturing, validation, and quality systems.

Preferred Qualifications

• Facilities and Utilities Commissioning and Qualification
• Computer System Validation
• Equipment Validation
• Risk Assessments and Risk Management
• KNEAT, CDOCS, SCADA, TrackWise, and Maximo
• Good Documentation Practices (GDP) and Data Integrity
• Change Controls
• Standard Operating Procedures (SOPs)
• Syringe and Vial Inspection Processes
• Document Revision and Approval
• Decision-Making Techniques

Functions

• Approve process validation protocols and reports for manufacturing processes.
• Represent Quality Assurance on incident triage teams.
• Approve Environmental Characterization Reports.
• Support the release of sanitary utility systems.
• Approve planned incidents.
• Represent QA on New Product Introduction (NPI) teams.
• Lead quality investigations.
• Own site Quality program procedures.
• Serve as the QA Manager's designee on the local Change Control Review Board (CCRB).

Education & Experience

Candidates must meet one of the following combinations:

• Doctorate + 2 years of directly related experience
• Master’s Degree + 4 years of directly related experience
• Bachelor’s Degree + 6 years of directly related experience
• Associate Degree + 10 years of directly related experience
• High School Diploma/GED + 12 years of directly related experience

Competencies & Skills

• Strong project management and organizational skills, including the ability to follow assignments through to completion.
• Ability to initiate and lead cross-functional teams.
• Strong leadership, influencing, and negotiation skills.
• Strong technical knowledge and expertise within the area of responsibility.
• Ability to collaborate and coordinate with higher-level external resources.
• Strong knowledge and experience in manufacturing and distribution, Quality Assurance, Quality systems, validation, and process development.
• Demonstrated ability to interact with regulatory agencies.
• Proficiency with word processing, presentation, database, and spreadsheet applications.
• Strong written and verbal communication, facilitation, and presentation skills.
• Ability to work independently and effectively interact with personnel at various organizational levels.
• Advanced data trending and evaluation skills.
• Ability to evaluate compliance issues and determine appropriate actions.
• Ability to demonstrate strong quality and leadership practices.