Sr Specialist QA

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