Quality Assurance Manager

OMIC USA Inc.; United States; On-site; USD 90,000 - 130,000; Full time

Job summary

OMIC USA, Inc. (Oregon) seeks a Quality Assurance Manager to verify quality, regulatory compliance, and SOP maintenance in the laboratory. You will lead continual improvement, coordinate the Quality Management System, and supervise QA staff to ensure GLP and ISO 17025 standards are met.

You will prepare regulatory reports, validate new methods, and coordinate audits. Strong documentation, training, and interdepartmental collaboration are essential in this role, reporting to Laboratory Management.

Qualifications

• Bachelor's degree in Chemistry or related science and 2 years QA/regulatory experience.
• Experience with ISO 17025, NELAC and/or GLP preferred.
• Strong ability to read and interpret regulatory documents.
• Ability to write and maintain SOPs and QA reports.

Responsibilities

• Be a proactive leader; identify opportunities and foster continual quality improvement of procedures.
• Coordinate and maintain the Quality Management System with Laboratory leadership and staff.
• Ensure annual internal audits of the quality management system for compliance.
• Prepare reports to regulatory agencies and clients (FDA/ODA data packages as examples).
• Verify new method validations align with policies and regulatory requirements.
• Write and maintain Quality System SOPs and related documentation.
• Conduct procedural audits to ensure accuracy and adherence to SOPs and regulations.
• Provide periodic reports on quality performance and audit findings with recommendations.
• Coordinate Annual Quality Review Meetings and Management Review of the Quality System.
• Manage calibration verification/maintenance of laboratory equipment.
• Assist with sales and marketing on QA-related inquiries.
• Coordinate and conduct QA training for laboratory personnel.
• Coordinate meetings to communicate regulatory updates and quality issues.

Skills

Regulatory compliance

Quality assurance

Audits

Documentation

GLP familiarity

Education

Bachelor's degree in Chemistry or related science

Job description

Job Description

Description:

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.

Requirements:

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, professiona