Job DescriptionWe are looking for an accomplished and driven Senior Chemist to join our growing team! The Senior Chemist will develop, apply, and maintain quality standards for sample testing process, documents, methods and procedures that comply with cGMPs, ICH, USP/NF, and FDA regulations and guidelines.
• Operate/maintain equipment, including preventive maintenance of laboratory equipment. Work with all employees at the facility.
• Participate in Performance Qualifications of equipment.
• Participate in Validations and Verifications.
• Must be aware of OSHA and EPA requirements for the laboratory to always ensure safe practices in the laboratory.
• Must be able to train chemistry staff in proper use of instrumentation and methodologies.
• Must be able to troubleshoot and optimize sample preparations and/or methodologies.
• Must be trainable to learn new instrumentation when necessary.
• Maintain all activities related to providing required documentation and implementing related documentation systems.
• Maintain compliance with regulatory requirements, cGMP guidelines, and acceptable scientific practice.
• Monitor and improve company SOP’s and methods.
• Maintain research and analysis activities according to applicable government regulations, or other considerations, and approves modification of analyses, tests, and processes.
• Maintain review and revision of procedures, specifications, and forms.
• Participate in improvement of organizational policies and operating procedures for the company.
• Maintain activities concerned with development, application, and maintenance of quality standards for internal processes including investigations and CAPAs.
• Keep abreast of regulatory procedures and changes.
• Maintain 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 when needed.
• Recommend response to complaints, considering test reports and records, legal standards, and complaint validity.
• Work with external departments, such as customer quality control, customer management, concerning observations and external audits.
• Attend professional conferences and seminars for information on techniques, instrumentation, and quality assurance/quality control.
• Minimum of a Baccalaureate Degree is required; concentration in Biological or Chemical Science is preferred.
• Two (2) years of regulatory, quality control, or quality assurance experience or equivalent is required.
• A minimum of five (5) years in the cosmetic, pharmaceutical, or related field, including at least one (1) year of supervisory experience, is required.
• A general working knowledge of 21CFR, USP/NF, ICH, cGMP, cGLP and/or ISO standards and guidelines.
• 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.