Chemist

Our client is seeking a motivated and detail-oriented Chemist to join our Quality Control Analytical team on a contract to hire basis. This role is pivotal in ensuring the quality and compliance of our products through meticulous analytical testing and adherence to regulatory standards.

Key Responsibilities:

1. Perform a range of analytical tests utilizing chromatography, spectroscopy, wet chemistry analysis, and other methods in accordance with Good Laboratory Practices (GLP).
2. Coordinate and conduct out-of-specification investigations, implement corrective actions, and drive continuous improvement initiatives.

• Prepare necessary documentation to track and manage "hold" items.
• Conduct Out of Specification investigations on raw materials, bulk, finished goods, and contract manufactured products.
• Ensure proper containment and handling of affected materials to prevent unintended use or distribution.
• Provide technical expertise and support cross-functional investigations.

1. Manage the raw material program and conduct testing on process water, swabs, and method transfer samples.
2. Support Operations with in-process adjustments such as color corrections, dispersions, and other analytical and physical tests to facilitate timely product disposition.
3. Communicate testing results promptly to internal and external stakeholders, including technical interpretations and recommendations.

• Collaborate closely with customer groups on cross-functional projects and lab throughput.

1. Ensure timely communication to customers and Quality management regarding operational issues, out-of-specifications, deviations, and coordinate external testing as necessary.
2. Responsible for IQOQPQ, calibration, and maintenance of laboratory equipment, including coordinating calibrations with external vendors.
3. Maintain a solid understanding of current FDA regulations and Good Manufacturing Practices (GMP) to ensure compliance in all laboratory activities.
4. Conduct training sessions for new members of the Quality Control Analytical team and actively seek opportunities to integrate scientific advancements for improved efficiency and productivity.

Qualifications:

• Bachelor’s degree or higher in Chemistry, Biochemistry, Pharmaceutical Sciences, or a related field.
• Previous experience in a similar role within the pharmaceutical, chemical, or related industry.
• Proficiency in analytical techniques and methodologies, including chromatography (HPLC, GC) and spectroscopy (UV-Vis, FTIR).
• Strong problem-solving skills and the ability to manage multiple projects simultaneously with meticulous attention to detail.
• Excellent verbal and written communication skills, with the ability to collaborate effectively across teams.
• Knowledge of FDA regulations and GMP guidelines preferred.
• Experience with laboratory equipment calibration and maintenance is advantageous.