Be the backbone of innovation and drive analytical chemistry services forward.
This role requires collaboration with various departments and maintaining high-quality laboratory practices to ensure compliance with regulatory standards.
Key Responsibilities:
* Conduct stability testing and provide analytical chemistry support.
* Collaborate with Quality Assurance, Production, Engineering, and Planning teams.
* Maintain and update chemical methods, specifications, and Standard Operating Procedures (SOPs).
* Train analysts in new methods and updates.
* Trend results, record on Certificates of Analysis, and complete investigations promptly.
* Communicate potential issues and suggest improvements to the QC Team Leader.
* Ensure quality documentation and records are current.
* Maintain compliance with Good Laboratory Practice (GLP) requirements.
* Define and follow relevant procedures accurately.
* Validate chemical testing equipment as required.
* Audit and review chemistry test results daily for compliance.
* Check and audit laboratory notebooks and analytical reports.
* Ensure adherence to current Good Manufacturing Practice (cGMP).
Requirements and Qualifications:
* Experience in stability testing.
* Strong analytical chemistry skills.
* Ability to interact effectively with multiple departments.
* Knowledge of pharmacopoeial and regulatory requirements.
* Proficiency in training and mentoring analysts.
* Familiarity with GLP and cGMP standards.
* Competence in equipment validation processes.
About the Role:
This is a key position that plays a crucial role in ensuring the quality and safety of products. The ideal candidate will have a strong background in analytical chemistry and excellent communication skills.