Job DescriptionWe are looking for an accomplished and driven Quality Specialist to join our growing team! The Quality Specialist will coordinate, and monitor activities of laboratory personnel engaged in sample testing process in relation to quality and apply knowledge of quality assurance and control standards and procedures.
• Design, revise and maintain the Quality system.
• Develop and instructions for recording, evaluating, and reporting quality data.
• Collaborate with management in maintaining company policies, operating procedures, and goals.
• Participate in activities concerned with development, application, and maintenance of quality standards for internal processes including investigations and CAPAs.
• Keep abreast of regulatory procedures and changes and provide the maintenance necessary to the Quality system.
• Contribute to the development, maintenance, implementation, and coordination of the Quality system to prevent or eliminate issues in new methods or existing ones.
• Suggest and debate alternative methods and procedures in solving problems and testing opportunities.
• Ensure retention of data and preparation of documents for use by self or other company personnel during inquiries and laboratory investigations.
• Participate in external, regulatory, and other audits and assist with internal audits.
• Develop and revise training material and conduct training sessions on quality control activities.
• Ensure QMS maintains completeness and accuracy.
• Review new or modified processes, including documentation, diagrams, and flow charts, to determine if the processes meet and conform to guidelines.
• Provide clerical and administrative support related to a company’s documentation system requirements.
• Assist in compiling regulatory filing documents and in maintaining computerized files to support all documentation systems.
• Work with all employees at the facility.
• Work with external departments, such as customer quality assurance and control and customer management, concerning observations and external audits.
• Attend professional conferences and seminars for information on techniques, instrumentation, and quality assurance/quality control.
• Other duties as required.
• Minimum of a Baccalaureate Degree is required; concentration in Science or Technical writing is preferred.
• A minimum of two (2) years in the cosmetic, pharmaceutical, or related field is required, and two (2) years of regulatory, quality control, or quality assurance experience or equivalent is preferred.
• A general working knowledge of 21CFR, USP/NF, ICH, cGMP, cGLP and/or ISO standards and guidelines.
• The ability to communicate clearly in English, both orally and in writing, with scientific and non-scientific personnel is required.
• The ability to communicate effectively and solve complex problems.
We value our employees as they are the key to our success. Our commitment to your success is enhanced by a competitive salary with an extensive benefits package. We work to maintain a progressive and collaborative work environment where we empower people and provide them with opportunities to develop their long-term career.
Certified Group is one of the largest and independent laboratories in the nation and is located in California, Illinois, New York, Virginia, and Texas. Each of our laboratories has its own area of expertise and is acknowledged as a leader in the field of food, cosmetics, and nutraceuticals safety and analysis.
Certified Group values diversity in its workforce. The company is firmly committed to a policy of Equal Opportunity and will administer its policies in a manner that treats each employee and applicant for employment on the basis of merit. Certified Group will take affirmative action to seek out qualified applicants without regard to race, color, religion, sex, national origin, age, handicap, or veteran status.