QC Chemist

Overview:

The QC Chemist is responsible for ensuring the quality and safety of products by performing stringent analytical tests on raw materials and finished products. This role contributes to the overall quality assurance and regulatory compliance within the pharmaceutical industry. The QC Chemist will play a crucial role in maintaining high standards of quality control throughout the production process, particularly focusing on Active Pharmaceutical Ingredients (APIs) and formulation integrity.

Key Responsibilities:

• Conduct qualitative and quantitative analyses on raw materials, in-process samples, and finished products.
• Prepare and standardize reagents and solutions for various testing procedures.
• Review and evaluate test results, and compile reports documenting analytical data.
• Perform routine maintenance and troubleshooting on laboratory equipment.
• Ensure compliance with Good Manufacturing Practices (GMP) and regulatory requirements throughout all QA processes.
• Collaborate with cross-functional teams to investigate and resolve quality issues.
• Participate in the development and validation of analytical test methods.
• Maintain accurate records of laboratory activities in accordance with company policies and regulatory standards.
• Support stability studies and quality audits as necessary.

Technical Skills:

• Proficiency in analytical techniques such as HPLC, GC, UV-Vis spectroscopy, and titration.
• Knowledge of laboratory information management systems (LIMS) and quality management systems.
• Familiarity with common laboratory equipment and safety protocols.
• Capability to interpret complex data and implement corrective actions as needed.
• Understanding of regulatory guidelines and industry standards, particularly in the pharmaceutical sector.

Required Qualifications:

• Bachelor’s degree in Chemistry, Pharmaceutical Sciences, or a related field.
• Proven experience in quality control within a pharmaceutical or biotech environment.
• Certification in Quality Assurance/Control is a plus.

Skills & Experience:

• Strong understanding of quality control processes relevant to pharmaceutical development and production.
• Experience specifically related to the Active Pharmaceutical Ingredients (API) field, with an emphasis on formulation and package testing.
• Ability to operate in a fast-paced environment while ensuring precision and accuracy in work.
• Excellent communication skills, both written and verbal, to interface effectively with team members and stakeholders.

By fostering a culture of quality, the QC Chemist will significantly impact product safety and efficacy in our pharmaceutical offerings.