Quality Assurance Manager

Responsibilities

• ESSENTIAL WORK ACTIVITIES: Other duties may be assigned.
• Be a proactive leader; identify opportunities and foster a culture of continual improvement of quality and procedures in the laboratory.
• 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

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.
• 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.
• 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 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
• CERTIFICATES, LICENSES, REGISTRATIONS: None
• 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

Preferred

• PREFERRED Skills and Experience
• Registered Quality Assurance Professional (RQAP)
• Registered Quality Assurance Professional for GLP regulations (RQAP-GLP)
• Laboratory analytical experience