Sr Specialist QA

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

Job summary

Biopharma-Consulting-Jad-Group seeks a Sr Specialist, Quality Assurance to provide technical QA leadership in a regulated manufacturing environment. You will review product documentation, validation protocols, environmental reports, and quality records while supporting cross‑functional teams and site quality programs.

The role requires advanced data trending, investigative skills, and strong regulatory understanding to ensure compliance with internal standards and regulatory expectations.

Qualifications

• Experience in regulated manufacturing and QA systems.
• Ability to review and approve MPs, validation protocols, and QA records.
• Strong data trending, investigations, and quality event closure.
• Effective written and verbal communication for cross‑functional teams.

Responsibilities

• Review and approve MPs and manufacturing procedures.
• Approve validation protocols and environmental reports.
• Lead investigations and ensure timely closure.
• Own site quality program procedures and change controls.
• Support audit readiness and regulatory interactions.

Skills

QA compliance

Validation

Documentation

Data trending

Cross-functional collaboration

Regulatory awareness

Problem solving

Communication

Education

Doctorate + 2 years of experience

Master’s + 4 years of experience

Bachelor’s + 6 years of experience

Associate’s + 10 years of experience

High School/GED + 12 years of experience

Tools

KNEAT

CDOCS

SCADA

TrackWise

Maximo

Job description

The Sr Specialist, Quality Assurance serves as a technical expert supporting quality systems, validation activities, and compliance within a regulated manufacturing environment. This role is responsible for reviewing and approving product documentation, validation protocols, environmental reports, and quality records. The specialist leads investigations, supports cross‑functional teams, and maintains ownership of key quality program procedures to ensure consistent adherence to regulatory and internal standards.

RESPONSIBILITIES

• Review and approve product manufacturing procedures (MPs).
• Approve process validation protocols and reports for manufacturing processes.
• Approve Environmental Characterization reports.
• Approve planned incidents and ensure proper documentation.
• Release sanitary utility systems in accordance with quality requirements.
• Represent Quality on incident triage teams.
• Represent QA on New Product Introduction (NPI) teams.
• Serve as designee for the QA Manager on the local Change Control Review Board (CCRB).
• Collaborate with Manufacturing, Facilities, Utilities, Validation, and Process Development teams.
• Lead investigations and ensure timely closure of quality events.
• Own and maintain site quality program procedures.
• Perform advanced data trending, evaluation, and compliance assessments.
• Support audit readiness and interact effectively with regulatory agencies.

SKILLS

• Strong knowledge of manufacturing, distribution, QA, QAL, validation, and process development.
• Ability to evaluate compliance issues and apply regulatory expectations.
• Advanced data trending and evaluation skills.
• Strong understanding of validation protocol execution requirements.
• Strong technical writing skills (reports, protocols, SOPs).
• Strong verbal communication, facilitation, and presentation skills.
• Proficiency in word processing, spreadsheets, databases, and documentation systems.
• Project management skills and ability to follow assignments through completion.
• Ability to initiate and lead cross‑functional teams.
• Strong influencing, negotiation, and decision‑making skills.
• Ability to work independently and interact effectively at all organizational levels.

• Doctorate + 2 years of directly related experience OR

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

PREFERRED QUALIFICATIONS

• Facilities & Utilities Commissioning and Qualification
• Computer System Validation (CSV)
• Equipment validation
• Risk assessments and risk management
• Experience with: KNEAT, CDOCS, SCADA, TrackWise, Maximo
• Good Documentation Practices (GDP)
• Data Integrity compliance
• Change Controls
• SOP development and revision
• Syringe/Vial inspection processes
• Document review and approval

• CONTRACT: 1 year with possible extension
• Administrative shift