Quality Assurance Manager
The Quality Assurance Manager verifies quality, policies, and regulatory compliance in the laboratory to achieve the company's mission and objectives. This role serves as a proactive leader, identifying opportunities and fostering a culture of continual improvement in quality and laboratory procedures.
Key Responsibilities Quality Management System Leadership
Coordinate and maintain the laboratory's Quality Management System with support from the Laboratory Director, Laboratory Manager, Group Leaders, and laboratory staff
Manage document control, quality records, and training documentation
Oversee internal and external audits, corrective and preventative actions
Coordinate proficiency testing scheduling, reporting, and follow-up
Ensure supplier qualification and traceability
Serve as archivist for GLP study-specific records
Compliance & Auditing
Conduct internal audits of the quality management system at least annually to maintain compliance with appropriate standards and accreditation programs
Identify areas of non-conformance and opportunities for improvement
Perform procedural audits of laboratory methods against SOPs, LABs, and regulatory requirements
Verify new method validations and improvements comply with policies and regulatory requirements
Documentation & Reporting
Write and maintain quality management system SOPs and documentation
Prepare special reports for regulatory agencies and clients (FDA data packages, ODA data packages, external audit responses)
Compile and prepare the annual Management Review of the Quality System Report
Make periodic reports to Laboratory Management on quality performance and audit details
Training & Communication
Coordinate and conduct quality assurance training for laboratory personnel
Conduct laboratory meetings to communicate operational information, regulatory updates, and quality improvements
Coordinate Annual Quality Review Meetings with Laboratory Management
Additional Duties
Coordinate and manage verification and maintenance of laboratory equipment calibration schedules
Assist with sales and marketing to existing and potential clients on QA-related inquiries
Supervise QA Associate/Assistant positions, including hiring, training, performance appraisals, and work assignments
Position Qualifications
Bachelor's degree (B.S.) in Chemistry or relevant science from a four-year college or university or equivalent combination of education and experience
2+ years of QA experience in regulatory compliance, preferably ISO 17025, NELAC, and/or GLP
Previous laboratory experience preferred
Advanced mathematical abilities, including exponents, logarithms, quadratic equations, statistical analysis, and variance analysis
Proficient in quality assurance/quality control evaluation procedures and audits
Technical writing experience for manuals and documentation
Highly competent user of MS Office
Core Competencies
Strong analytical and problem-solving abilities
Excellent interpersonal and communication skills
Ability to lead, motivate, and supervise teams
Proven experience in change management
Successful collaboration with multiple business departments
Ability to interpret technical instructions and regulations
Knowledge of laboratory business environment and industry best practices
Preferred Qualifications
Registered Quality Assurance Professional (RQAP) certification
Registered Quality Assurance Professional for GLP regulations (RQAP-GLP)
Laboratory analytical experience
Experience working in international businesses with cultural awareness
Position Benefits
Medical/Vision Insurance
The company covers 100% of EE premiums and 90% of dependents
HSA- the company covers 100% of the premium and contributes to the HSA every month
Dental insurance
LTD
FSA
Supplemental Insurance
LegalShield/IDShield
401(k)
PTO
13 paid holidays
Partnership with Adidas and the Columbia employee stores
Year-end bonus dependent on company performance
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Key Responsibilities Quality Management System Leadership
Coordinate and maintain the laboratory's Quality Management System with support from the Laboratory Director, Laboratory Manager, Group Leaders, and laboratory staff
Manage document control, quality records, and training documentation
Oversee internal and external audits, corrective and preventative actions
Coordinate proficiency testing scheduling, reporting, and follow-up
Ensure supplier qualification and traceability
Serve as archivist for GLP study-specific records
Compliance & Auditing
Conduct internal audits of the quality management system at least annually to maintain compliance with appropriate standards and accreditation programs
Identify areas of non-conformance and opportunities for improvement
Perform procedural audits of laboratory methods against SOPs, LABs, and regulatory requirements
Verify new method validations and improvements comply with policies and regulatory requirements
Documentation & Reporting
Write and maintain quality management system SOPs and documentation
Prepare special reports for regulatory agencies and clients (FDA data packages, ODA data packages, external audit responses)
Compile and prepare the annual Management Review of the Quality System Report
Make periodic reports to Laboratory Management on quality performance and audit details
Training & Communication
Coordinate and conduct quality assurance training for laboratory personnel
Conduct laboratory meetings to communicate operational information, regulatory updates, and quality improvements
Coordinate Annual Quality Review Meetings with Laboratory Management
Additional Duties
Coordinate and manage verification and maintenance of laboratory equipment calibration schedules
Assist with sales and marketing to existing and potential clients on QA-related inquiries
Supervise QA Associate/Assistant positions, including hiring, training, performance appraisals, and work assignments
Position Qualifications
Bachelor's degree (B.S.) in Chemistry or relevant science from a four-year college or university or equivalent combination of education and experience
2+ years of QA experience in regulatory compliance, preferably ISO 17025, NELAC, and/or GLP
Previous laboratory experience preferred
Advanced mathematical abilities, including exponents, logarithms, quadratic equations, statistical analysis, and variance analysis
Proficient in quality assurance/quality control evaluation procedures and audits
Technical writing experience for manuals and documentation
Highly competent user of MS Office
Core Competencies
Strong analytical and problem-solving abilities
Excellent interpersonal and communication skills
Ability to lead, motivate, and supervise teams
Proven experience in change management
Successful collaboration with multiple business departments
Ability to interpret technical instructions and regulations
Knowledge of laboratory business environment and industry best practices
Preferred Qualifications
Registered Quality Assurance Professional (RQAP) certification
Registered Quality Assurance Professional for GLP regulations (RQAP-GLP)
Laboratory analytical experience
Experience working in international businesses with cultural awareness
Position Benefits
Medical/Vision Insurance
The company covers 100% of EE premiums and 90% of dependents
HSA- the company covers 100% of the premium and contributes to the HSA every month
Dental insurance
LTD
FSA
Supplemental Insurance
LegalShield/IDShield
401(k)
PTO
13 paid holidays
Partnership with Adidas and the Columbia employee stores
Year-end bonus dependent on company performance
#J-18808-Ljbffr