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QA Analyst I
Department: Quality Assurance
Job Description: Develop and support a quality system that establishes and maintains effective quality assurance processes and compliance to current Good Manufacturing Practice (cGMP).
Duties/Responsibilities: • Execute various and non-routine quality assurance processes to ensure quality system integrity, GMP compliance, and product quality output. • Plan, organize, monitor, review and control functions related to establishing and maintaining a quality system, engineering, compliance, and document management system consistent with internal requirements and Good Manufacturing Practice regulations. • Write, edit, and implement operating policies, procedures, validation protocols, and reports related to internal quality systems and GMP. • Establish and maintain quality assurance databases, archives, and websites. • Investigate, acquire, develop, review, conflict resolve, and propagate product master and batch records, product and part specifications, engineering schematics, and other documents necessary for developing internal quality standards and systems. • Communicate and teach quality standards, policies, procedures, and specifications to other departments, customers, governments, and vendors. • Implement and support quality and statistical tools such as TQM, SPC, Process Maps, DMIAC, DMADV, etc. • Maintain a supplier management system. • Conduct internal and supplier audits. • Investigate and resolve product and process problems related to quality issues. • Investigate and resolve customer complaints and adverse events. • Adhere to quality system policies, procedures, processes, and comply with cGMP. • Perform other duties as assigned or needed. • Plan projects in accordance with company and business objectives. • Investigate and resolve matters of significant importance in accordance with company and business objectives. • Resolve complaints and disputes as a representative of the company.
Qualifications: • A bachelor’s degree • Preference for a life-scientific field of study, or; • Training, certification, or additional educational class related to life-sciences and laboratory services • Minimum 4 years experience in quality assurance and cGMP. • Strong written and oral communication skills with a proficiency in the English Language • Detailed and analytic oriented abilities. • Must be willing to learn new tasks and procedures. • Ability to supervise projects and give directions. • Ability to perform all essential position duties and responsibilities, with or without reasonable accommodation and without posing a direct safety threat to others or self, in an efficient and effective manner
Salary Range*: null
Location: Salt Lake City
Posting Date: 10/13/2008
Open Until Filled
Contact: hrusana@usana.com
*Salary Disclaimer - The salary listed is a minimum only or refers to an internal grade. Final salary is commensurate with related skills, education, experience and abilities and will be determined in the interview.
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