We are seeking an experienced and highly motivated Quality Control Chemistry Manager to lead our onsite analytical chemistry processes, procedures, and administration duties. The successful candidate will be responsible for meeting the quality standards and compliance of raw materials, in-process samples, and finished products through the development and execution of analytical methods and procedures and managing a team technicians and scientists. They will also oversee the daily operations of the QC chemistry laboratory, manage and mentor a team of chemists, good documentations practices and collaborate with cross-functional teams to drive continuous improvement.
Responsibilities:
- Lead, manage, and mentor a team of QC chemists, providing technical guidance, training, and performance feedback.
- Set clear goals and objectives for the QC chemistry team, aligning with overall company quality objectives.
- Responsible for analytical methods transfer and validation for raw materials, in-process samples, and finished products, ensuring accuracy, precision, and robustness.
- Facilitate the evaluation of new testing applications and instrumentation.
- Ensure compliance with relevant regulatory requirements and industry standards.
- Oversee the execution of routine and non-routine QC testing, ensuring adherence to established procedures and protocols.
- Review and approve test results, investigate deviations and out-of-specification results, and initiate corrective and preventive actions.
- Maintain accurate and complete records of all QC testing activities. Report non-conformances/deviations/out-of-specifications events.
- Ensure the QC chemistry laboratory is maintained in a safe, clean, and organized manner.
- Manage laboratory equipment and supplies, ensuring calibration and maintenance are performed as required.
- Provide guidance to troubleshooting with instruments, test methods, lab chemicals, standards and samples handling.
- Maintain compliance with Good Laboratory Practices and other relevant regulatory requirements.
- Collaborate with cross-functional teams, including Research and Development, Manufacturing, and Quality Assurance, to ensure smooth and efficient product development and release.
- Participate in internal and external audits, providing technical expertise and support.
Qualifications:
- Education:
- Bachelor’s or Master’s or PhD degree in Chemistry, Analytical Chemistry, or a related field
- Experience:
- Minimum of 10 years of experience in a QC chemistry laboratory ideally in a manufacturing setting, with at least 5 years of supervisory experience of a QC team
- Skills:
- Proficient in the use of analytical instrumentation and software
- HPLC, preferably Agilent 1260
- Experience with calibration standard settings for HPLC
- Rheometer
- Viscometer
- UV Vis measurement
- Colorimeter
- Analytical balance
- Proficient in chemical handling
- GSH SDS (MSDS) interpretation
- Expertise in Good Laboratory Practices (GLP)
- Strong knowledge of ISO standards (minimum 9001) and other relevant regulatory requirements
- Strong analytical and problem-solving skills
- Proficient in English and Spanish