Summary: The Specialist Quality Assurance supports the Quality Assurance (QA) program by performing a wide range of duties with minimal supervision.
This role involves ensuring compliance with Good Manufacturing Practices (GMP), leading investigations, supporting facility and environmental programs, and collaborating with cross-functional teams to uphold quality standards.
Responsibilities: Review and approve manufacturing product Master Plans (MPs).
Approve process validation protocols and reports.
Participate in incident triage teams and approve planned incidents.
Approve Environmental Characterization reports.
Release sanitary utility systems.
Represent QA in New Product Introduction (NPI) teams.
Lead investigations and site audits.
Own and maintain site quality program procedures.
Act as the QA Manager's designee on the local Change Control Review Board (CCRB).
Review and approve Risk Assessments, Work Orders, and EMS/BMS alarms.
Approve non-conformance (NC) investigations, corrective and preventive actions (CAPA), and change controls.
Provide lot disposition and authorize lots for shipment.
Support automation activities and facilities/environmental programs.
Skills and Competencies: Strong project management and organizational skills.
Ability to initiate and lead cross-functional teams.
Expertise in QA processes, manufacturing, validation, and process development.
Advanced data trending and evaluation abilities.
Proficiency in word processing, presentations, databases, and spreadsheets.
Strong oral and written communication, facilitation, and presentation skills.
Demonstrated ability to interact with regulatory agencies and manage compliance issues.
Requirements Qualifications: Doctorate degree OR Master's degree and 3 years of Quality and/or Manufacturing experience OR Bachelor's degree and 5 years of Quality and/or Manufacturing experience OR Associate's degree and 10 years of Quality and/or Manufacturing experience OR High school diploma/GED and 12 years of Quality and/or Manufacturing experience Preferred Qualifications: Fluent in English and Spanish, with strong technical writing skills in English.
Proven problem-solving skills with the ability to work autonomously and provide updates to senior management.
Experience in dynamic cross-functional teams with sound decision-making abilities.
Strong organizational skills and ability to drive assignments to completion.
Demonstrated leadership capabilities and experience applying GMP requirements in an operational setting.
Self-starter with the ability to independently interact across various organizational levels.