Summary:
As a Quality Control Senior Chemist, you will be responsible for overseeing the quality control activities related to chemical testing and analysis of our medical devices. You will collaborate closely with cross-functional teams to ensure compliance with regulatory requirements, develop and validate analytical methods, and implement quality control procedures. Your expertise and attention to detail will contribute to maintaining the highest standards of quality and safety for our products.
Key Duties and Responsibilities:
Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions
- Lead and supervise a team of chemists in the Quality Control laboratory.
- Develop and validate analytical methods for the analysis of raw materials, intermediates, and finished medical devices.
- Perform chemical testing and analysis using various techniques.
- Review and interpret test results, ensuring accuracy and compliance with specifications and standards.
- Investigate and resolve any deviations or out-of-specification results, implementing corrective and preventive actions as necessary.
- Collaborate with R&D, manufacturing, and regulatory teams to support product development, process improvement, and regulatory submissions.
- Ensure compliance with relevant regulatory guidelines, such as ISO standards, FDA regulations, and other applicable quality standards.
- Participate in internal and external audits, providing necessary documentation and support.
- Maintain laboratory equipment, calibrate instruments, and ensure proper functioning and maintenance.
- Keep abreast of industry trends, advancements, and regulatory changes related to quality control and analytical testing.
- Performs other duties as needed.
Qualifications, Education and/or Experience Required:
- A 4-year degree in chemistry or related field, and 3-4 years of experience in a Quality Control Lab or similar chemistry field.
- Familiarity with analytical testing concepts, practices, and instrumentation/equipment use and maintenance.
- Excellent understanding of statistical analysis and quality control principles.
- Proficiency with Microsoft Office required (Excel, Word, Office).
Language Skills:
- English required, bilingual (Spanish) a plus.
Physical Demands:
- Walking, standing for prolonged periods, may frequently lift/move up to 10 pounds and occasionally lift/move up to 25 pounds, good manual dexterity for proper laboratory techniques.
- Respirator (full/half face) required for certain tasks.
Work Environment:
- Chemical Laboratory – exposure to chemicals including, but not limited to: cyanoacrylates and organic solvents.
- Must follow all laboratory/company safety procedures, including Lone Worker policy (second shift) and wear proper PPE.
Other Duties:
Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities, and activities may change at any time with or without notice.
AAP/EEO Statement:
CHEMENCE® provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state, or local laws. This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation, and training.
