Specialist QA

This position supports the Quality Assurance program by executing a broad range of responsibilities with minimal supervision. The role is ideal for candidates with strong experience in manufacturing quality systems, validation, and regulatory compliance.

Key Responsibilities:

• Review and approve Master Production Records (MPs)
• Approve process validation protocols and reports
• Participate in incident triage and approve planned incidents
• Approve Environmental Characterization reports and sanitary utility system releases
• Represent QA on New Product Introduction (NPI) teams
• Lead investigations and site audits
• Own and manage site quality program procedures
• Serve as designee for QA Manager on local Change Control Review Board (CCRB)
• Review risk assessments and support automation, facilities, and environmental programs
• Review and approve work orders and EMS/BMS alarms
• Approve non-conformance investigations and CAPA records
• Approve change controls and authorize lot disposition for shipment

Skills:

• Strong project management and organizational skills
• Ability to lead cross-functional teams and influence stakeholders
• Expertise in QA, QAL, manufacturing, validation, and process development
• Skilled in regulatory interaction and compliance evaluation
• Advanced data trending and analysis
• Proficient in MS Office (Word, Excel, PowerPoint, databases)
• Excellent communication, facilitation, and presentation abilities
• Ability to work independently and collaborate across all levels

Requirements

• Doctorate (PhD)
• Master’s degree + 2 years of directly related experience
• Bachelor’s degree + 4 years of directly related experience
• Associate’s degree + 8 years of directly related experience
• High School Diploma/GED + 10 years of directly related experience

Preferred Qualifications:

• Experience with New Product Introduction (NPI)
• Familiarity with Change Control processes
• Exposure to Factory Acceptance Testing (FATs)
• Hands-on experience with Validation and Process Performance Qualification (PPQ)

Benefits

• 10- months contract with possible extension
• Administrative Shift