The Quality Assurance Specialist II oversees requirements for continuing cGMP training to keep all employees aware of their responsibilities and changing requirements for cGMP compliance.
Works collaboratively with Manufacturing, Engineering, Quality Control, and other functional experts to support all daily operational activities.
Functions as an information source to various company departments when special and critical quality issues occur.
Conducts internal audits of production facilities assuring company standards and product integrity are maintained.
Consults with management to resolve quality, production, and efficiency problems.
Functions in conjunction with manager and functional experts on special department projects.
Works with internal departments to ensure implementation, maintenance, and improvement of the quality management system.
Performs the essential duties and responsibilities as listed in section below.
Writes and revises operating procedures
Conducts training for staff at all levels as it relates to quality systems
Processes document change requests and training records
Compiles quality metrics for daily/weekly/monthly reporting and reports metrics to site management
Compiles information for Quality Management Review
Conducts inspections of materials
Reviews records for compliance such as inspection reports, test records, and Device History Records
Updates component, product, and documentation databases
Reviews validation/qualification reports for GMP and quality system compliance
Conducts complaint investigations
Conducts CAPA investigations, proposes corrective and preventative actions, and conducts verification and effectiveness reviews
Investigates and reviews Nonconforming Material reports and presents reports/metrics during periodic meetings
Evaluates supplier quality performance and conducts periodic evaluations of suppliers
Conducts internal audits
Participates in audits/inspections by customers and regulatory agencies and compiles corrective and preventative action responses
Other duties may be assigned as necessary
Associates Degree with related work experience is required. A Bachelor s Degree is preferred.
A minimum of 4 years experience in a Quality/Regulatory Compliance environment.
Familiarity with application of FDA and/or ISO quality standards in a government regulated industry.
Moderate computer competence, including experience with database and Microsoft Office.
Knowledge of QA terms, tools, and methodologies.
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