| Company: | ZARS, Inc. |
| Job Location: |
Salt Lake City - Salt Lake County |
| Employment Type: | Full Time |
| Salary Range: | not specified |
Description: |
Job Summary:
Develop, implement and maintain the activities of the quality control systems within the laboratory and manufacturing operations. This position develops and implements standards, methods and procedures for inspecting, testing and evaluating the identity, strength, quality and purity of products and materials. Manages and coordinates the activities of the support staff. Assures finished products conform to government and company standards and satisfy GMP regulations. The position ensures effective operation of all laboratory equipment. Provides recommendations for corrective actions necessary to assure conformity with quality specifications. Trains the support staff in the general use and function of designated instrumentation and test methods.
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Duties: |
Duties and Responsibilities:
• Establish and maintain the internal Quality Control activities to support third party manufacture, analytical testing, release testing, and clinical testing of investigational new drugs.
• Be the QC/Laboratory lead for cross-functional projects providing appropriate timelines, plans and position strategies.
• Design and oversee the completion of qualification protocols and reports for test equipment and laboratory facilities.
• Design and oversee the completion of test method validation protocols and reports.
• Design and oversee the completion of stability studies and reports.
• Participate in the establishment of specifications for raw materials and products.
• Review and approve all test results for accuracy, completeness and appropriateness.
• Report non-conforming test results and activities in a timely fashion and suggest corrective actions.
• Write departmental standard operating procedures (SOPs).
• Train new and current employees on internal quality assurance programs, processes, policies and procedures.
• Promote quality by training employees on current quality procedures, leading investigations and follow-ups and implementing appropriate quality improvement activities with other departments both internally and externally.
• Operate the QC/Laboratory functions within the approved departmental budget.
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Qualifications: |
Knowledge, Skills, and Abilities:
• Excellent knowledge and expertise with FDA regulations in the practice of GMPs, GLPs and GCPs.
• Experience in the development and implementation of QC/laboratory procedures and equipment.
• Strong background in analytical chemistry.
• Motivated, with the organizational skills that allow the timely completion of deliverables.
• Performs tasks efficiently, independently and as part of a team.
• Flexible work habits for an ever-evolving, small company environment.
• Excellent English communication skills (both written and verbal).
• Minimum of Bachelors Degree in science-related field.
• Minimum of 5 years QC/Laboratory experience in the pharmaceutical industry
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