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OMIC USA, Inc., Oregon believes that each employee makes a significant contribution to its success. That contribution should not be limited by the assigned responsibilities. Therefore, this position description is designed to outline primary duties, qualifications, and job scope, but not limit the incumbent nor the company to just the work identified. It is OMIC’s expectation that each employee will offer their services wherever and whenever necessary to ensure the success of the Company.

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: Other duties may be assigned.

1. Be a proactive leader; identify opportunities and foster a culture of continual improvement of quality and procedures in the laboratory.
2. Coordinate and maintain the laboratory’s Quality Management System with support from the Laboratory Director, Laboratory Manager, Group leaders, and laboratory staff including:

• Document Control and Quality Records
• Training Documentation
• Internal and External Audits
• Corrective & preventative actions, and continuous improvement  
• Proficiency testing; scheduling, reporting & follow up
• Supplier qualification, and traceability
• Archivist for GLP study specific records

3. Ensure internal audits of the quality management system are performed at least once a year to maintain compliance with the appropriate standards and accreditation programs and identify areas of non-conformance and/or areas for improvement.

4. Prepare special reports to regulatory agencies and/or clients; for example – summary reports of analytical results, external audit responses, FDA data packages, and ODA data packages.

5. Verify new method validations and improvements are in compliance with OMIC’s policies as well as regulatory requirements.

6. 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. 

7. 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. 

8. Make periodic reports to the Laboratory Manager and Director as to the quality of the laboratory’s performance and audit details (observations, findings, non-compliances, and non-conformances). Make recommendations as on necessary steps to be taken to ensure improvements.

9. Coordinate Annual Quality Review Meetings with Laboratory Management, compile the necessary data/information throughout the year and prepare the annual Management Review of the Quality System Report.

10. Coordinate and manage the verification and/or maintenance of scheduled calibration of laboratory support equipment. 

11. Assist with sales and marketing to existing and potential clients on QA related enquiries.

12. Coordinate and conduct laboratory meetings with personnel to communicate information on laboratory operations, regulatory updates, quality improvements, and quality issues.

13. Coordinate and conduct quality assurance training for laboratory personnel.

SUPERVISORY RESPONSIBILITIES

Manages the QA Associate/Assistant position(s). Carries out supervisory responsibilities in accordance with the organization's policies and applicable laws. Responsibilities include interviewing, make recommendation for hiring, training new employees; planning, assigning, and directing work; appraising performance. 

QUALIFICATIONS: To perform this job successfully, an individual must be able to perform each essential work activity satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

EDUCATION and/or EXPERIENCE 

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.

LANGUAGE SKILLS 

Ability to read, analyze, and interpret general business periodicals, professional journals, technical procedures, or governmental regulations. Ability to write SOPs, reports, business correspondence, and procedure manuals. Ability to effectively present information and respond to questions from subordinates, clients, customers, and the general public.

MATHEMATICAL SKILLS 

Ability to apply advanced mathematical concepts such as exponents, logarithms, and quadratic equations.  Ability to apply mathematical operations to such tasks as frequency distribution, determination of test reliability and validity, analysis of variance, correlation techniques, sampling theory, and factor analysis.

Ability to perform standard quality assurance / quality control evaluation procedures, including audits. Technical writing for preparing manuals and documentation.

REASONING ABILITY 

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.

OTHER REQUIRED SKILLS & EXPERIENCES

• Familiar with the laboratory business environment

• Successful experience of collaborating with different business departments

• Demonstrated successful experience of leading, motivating, and supervising teams of relevant significance

• Demonstrated experience of successful change management of relevant complexity

• Connected well with relevant external organizations and good knowledge of the industry best practice

• Experience working in international businesses and a good cultural awareness

• Excellent interpersonal skills

• Strong analytical and problem-solving skills

• Excellent in other OMIC’s performance factors

• Highly competent user of MS Office

PREFERRED

• Registered Quality Assurance Professional (RQAP)

• Registered Quality Assurance Professional for GLP regulations (RQAP-GLP)

• Laboratory analytical experience

TRAINING REQUIREMENTS

OJT in understanding company operating systems, including the maintenance and operation of extraction analytical equipment, and passing the Initial Demonstration of Capability (IDOC) for existing SOPs.

PHYSICAL DEMANDS The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

While performing the duties of this job, the employee is regularly required to be able to hear and understand instructions, and handle items involving repetitive hand and wrist movement.

WORK ENVIRONMENT The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job.  Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Works in laboratory using analytical equipment. Employee may have exposure to hazardous chemicals and solvents.