Vacancy expired!
Stefanini Group is looking for a Quality Engineer in Irvine, CA that can start ASAP. The Quality Analyst will be a senior quality representative on a team responsible for quality oversight of a commercial aseptic manufacturing and packaging facility. This role supports the quality engineering team in an individual contributor capacity focusing on: independent review and QA approval of maintenance work orders, manufacturing and laboratory equipment/instrument commissioning/qualifications, facilities, critical utilities (WFI, CCA, HVAC, CSM, etc.), computer systems, media fills, and process/product validations, and continuous improvement projects. Work in collaboration with other key operational departments to resolve complex quality and operational issues.Provide effective and timely decision-making, project management, and teamwork skills utilizing risk-based approaches, especially with real-time unplanned maintenance work order approvals, emergency change controls, and project support.Collaborate with Engineering and Production especially in execution of risk assessments, and support the area Quality manager responsible for quality oversight of re-commissioning of the plant facilities and critical utilities after facility shutdown.Lead various projects including continuous improvement activities, and leverage lean/OPEX principles to ensure robust and efficient compliant systems and processes.Review and approve independently the following GMP documents: facility and maintenance work orders, controlled logbooks supporting facilities, pest control reports, validation periodic review protocols and reports, Standard Operating Procedures (SOPs), change control documents, minor and major deviation investigations, engineering drawings, and HEPA recertification reports.Support the Aseptic Process Simulation program at Irvine ensuring all requirements are met and product/APS matrix is current.Execute and improve assigned key performance work metrics using trend charts and/or statistical analysis in support of continuous improvement and Annual Product Reviews and department metrics.Actively support inspections/audits of Irvine by Regulatory agencies/internal auditors.
Requirements: Bachelor s degree in related Science, Life Science or Engineering field required. Master s degree is preferred. Additional relevant certifications preferred (ASQ and similar).Minimum 10 years experience in the pharmaceutical or Biopharma industry required.2 years in an aseptic/sterile manufacturing facility required. 4 years preferred.3+ years working with Equipment Qualification and Process Validation in a commercial GMP operation preferred.3 years experience using contemporary approach to Commissioning and Qualification preferred.Validation using risk-based approach leveraging Critical Process Parameters and Critical Qualification Attributes preferred.2+ years working directly within a Quality Assurance role supporting review and approval of technical documents in a commercial operation preferred.Experience actively interacting with FDA or other regulatory bodies in GMP/PAI inspections as an area SME, host, escort or scribe strongly preferred.Experience in auditing techniques in a cGMP aseptic/sterile facility with the ability to gown for clean room environment.Working knowledge in Root Cause Analysis (5 Whys, 6M s, Is/Is Not, FMEA, etc.) in support of deviation/CAPA investigations to determine adequate and effective CAPAs.Working knowledge of GAMP 5 and Parenteral Drug Association (PDA) requirements.Working knowledge of Lean/5s, and/or DMAIC tools.Demonstrated effective teamwork experience and ability to indirect develop lower level quality personnel and provide leadership to internal/external customers including providing internal technical training.Ability to provide effective prioritization and project management skills to manage the day to day along with longer-term projects/tasks while ensuring the facility is compliant.Ability to interpret current Good Manufacturing Practices (cGMP), Food and Drug Administration (FDA), and other regulatory requirements applicable to operations supporting aseptic/sterile manufacturing and packaging functions.Experience with risk-based decision making on a strategic level affecting multiple systems, facilities, batches, etc.Vacancy expired!