The Quality Assurance Specialist will perform critical functions within a bio-pharmacy facility, ensuring compliance and operational excellence in manufacturing and related processes.
The ideal candidate will have strong expertise in quality systems, risk assessments, validation processes, and regulatory compliance, with the ability to lead and influence cross-functional teams.
Responsibilities: Review and approve Manufacturing Process (MP) documentation.
Approve process validation protocols and reports for manufacturing processes.
Serve as the QA representative on incident triage teams.
Approve Environmental Characterization reports and oversee sanitary utility system releases.
Evaluate and approve planned incidents, Work Orders, and EMS/BMS alarms.
Represent QA in New Product Introduction (NPI) teams.
Lead investigations, site audits, and cross-functional quality improvement initiatives.
Own and manage site quality program procedures and provide oversight on quality records (NCs, CAPAs, and change controls).
Act as a QA manager designee on the local Change Control Review Board (CCRB).
Review and approve risk assessments and lead efforts to ensure compliance with data integrity standards.
Support automation, facilities, and environmental programs to maintain quality standards.
Provide final lot disposition authorization for product shipment.
Skills: Strong project management and organizational skills.
Proficiency in quality assurance processes and regulatory requirements.
Ability to lead cross-functional teams, influence stakeholders, and negotiate effectively.
Advanced skills in data analysis, trending, and compliance evaluation.
Strong written and oral communication, facilitation, and presentation abilities.
Expertise in manufacturing and distribution processes, validation, and process development.
Proficiency in word processing, presentation tools, databases, and spreadsheets.
Ability to manage multiple priorities and work independently with minimal supervision.
Requirements Qualifications: Doctorate degree or Master's degree with 3+ years of related experience, OR Bachelor's degree with 5+ years of related experience, OR Associate degree with 10+ years of related experience, OR High school diploma/GED with 12+ years of related experience.
Preferred Background: Degree in sciences (e.g., biology, chemistry, biotechnology).
Knowledge of Warehouse and Incoming QC operations.
Familiarity with quality oversight processes, quality records (deviations, CAPAs, change controls), and data integrity standards.