Description:
Quality Control (QC) Analyst is responsible for sample receipt, testing intermediate production
samples, final product samples, and environmental samples to demonstrate that all products meet the standard requirements for CGMP operations. Additional functions include raw material testing, stability testing, assay transfers, and qualification of instrumentation. The Quality Control Operations group supports Laboratory Investigations, Deviation Investigations, CAPA support, Training, and Change Controls. Quality Control Validation Support consists of the Method Validation Group and the Equipment Qualification Group. Quality Control is also responsible for assisting in site wide studies and projects.
Responsibilities
- Executing analytical testing in a timely manner, ensuring adherence to the committed scheduled plans
- Performing his/her tasks in accordance with cGMP and HSE requirements, and with the associated instructions, procedures, records, related to these tasks
- Recording all expected raw data, calculations, information, related to his/her tasks, to comply with cGMP and data integrity requirements
- Ensuring that he/she is trained and qualified to the assigned analytical testing that requires to be qualified
- Performing the QC data review of executed tests by other analysts in a timely manner, ensuring adherence to the committed scheduled plans
- Informing his/her manager of any quality or HSE event (deviations, OOx,…) in a timely manner to ensure investigation and impact assessment are performed appropriately
- Participating actively to any investigation, where he/she is involved, to ensure investigations and impact assessment are performed appropriately
- Executing assigned CAPAs related to remediation plans, continuous improvements
- Ensuring that his/her lab/facilities, lab instruments are kept in a quality and safety status to ensure that they can be used appropriately.
Qualifications
- Bachelor's degree in Pharmacy, Chemistry, Biochemistry, Microbiology, Life Sciences, or related field.
- 3+ years experience
- Analytical testing of raw materials, intermediate, final products, and environmental samples.
- Hands-on experience with laboratory instruments such as HPLC, GC, UV-Vis, dissolution testers, etc.
- Performing stability testing, assay transfers, and method validations.
- Experience in QC data review, recording raw data, and calculations according to cGMP and data integrity requirements.
- Participation in laboratory investigations, deviation investigations, and CAPA implementation.
- Knowledge of change controls, training, and site-wide quality improvement projects.
- Strong knowledge of cGMP, HSE standards, and laboratory safety protocols.
- Ability to execute, record, and review analytical test results accurately and timely.
- Proficient in documentation, SOP adherence, and data integrity compliance.
- Familiarity with instrument qualification, method validation, and routine lab maintenance.