Quality Assurance Manager

Description

OMIC USA, Inc., Oregon values each employee's contributions to its success. This position description outlines primary duties, qualifications, and job scope, but does not limit the incumbent or the company to these tasks. OMIC expects all employees to contribute where needed to ensure the company's success.

Mission Of The Role

Quality Assurance Manager verifies the quality, policies, and regulatory compliance in the laboratory to achieve the Company’s mission and objectives.

ESSENTIAL WORK ACTIVITIES

• Proactively lead; identify opportunities and foster a culture of continual improvement in quality and procedures within the laboratory.
• Coordinate and maintain the laboratory’s Quality Management System with support from the Laboratory Director, Laboratory Manager, Group leaders, and laboratory staff.
• Document Control and Quality Records, Training Documentation, Internal and External Audits, Corrective & Preventative Actions, and Continuous Improvement.
• Ensure Supplier qualification and traceability, and Archivist for GLP study specific records.
• Perform periodic reports to the Laboratory Manager and Director regarding the quality of the laboratory’s performance and audit details.
• Prepare special reports to regulatory agencies and/or clients, such as summary reports of analytical results, external audit responses, FDA data packages, and ODA data packages.
• Verify new method validations and improvements are compliant with OMIC’s policies and regulatory requirements.
• Write and maintain quality management system SOPs and documentation in collaboration with other members of the QAU, Laboratory Manager, Laboratory Director, and other relevant departments.
• Coordinate and/or complete review of other controlled laboratory documentation for compliance and quality.
• Perform procedural audits of methods conducted in the laboratory against the appropriate SOPs, LABs, and regulatory requirements to ensure accuracy of procedural documentation and adherence to laboratory procedures.
• Coordinate and manage the verification and/or maintenance of scheduled calibration of laboratory support equipment.
• Aid in sales and marketing efforts to existing and potential clients on QA-related inquiries.
• Coordinate and conduct laboratory meetings with personnel to communicate information on laboratory operations, regulatory updates, quality improvements, and quality issues.
• Coordinate and conduct quality assurance training for laboratory personnel.
• Manage the QA Associate/Assistant position(s).

Requirements

• Bachelor's degree (B.S.) in Chemistry or relevant science from a four-year college or university; previous laboratory experience preferred, and 2 years QA experience in regulatory compliance, preferably ISO 17025, NELAC and/or GLP; or equivalent combination of education and experience.
• Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
• Ability to define problems, collect data, establish facts, and draw valid conclusions.
• Ability to interpret an extensive variety of technical instructions in mathematical or diagram form and deal with several abstract and concrete variables.
• Experience collaborating with different business departments, leading, motivating, and supervising teams, and managing change.
• Experience working in international businesses and a good cultural awareness.
• Strong interpersonal skills, analytical, and problem-solving abilities.
• Highly competent user of MS Office.
• Preferred: Registered Quality Assurance Professional (RQAP), Registered Quality Assurance Professional for GLP regulations (RQAP-GLP), Laboratory analytical experience, and OJT in understanding company operating systems.

Physical Demands

• Works in a laboratory using analytical equipment.
• Exposure to hazardous chemicals and solvents.