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.

Requirements

• 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

Benefits

• CONTRACT: 1 year with possible extension
• Administrative shift