Quality Control Analyst
Kalexsyn is currently seeking a highly motivated and team-oriented candidate for the position of Quality Control Analyst. Experience with API approval and release as well as method validation is required. The successful candidate will be able to work with minimal supervision within a supportive team environment.
- Bachelor’s degree in a scientific field required
- Three to five years of experience in a QC laboratory preferred.
- Extensive knowledge of GMP regulations.
- Proven experience with analytical method optimization, validation, and troubleshooting.
- Experience in preparing for or participating in laboratory compliance audits and/or inspection by regulatory agencies.
- Strong attention to detail, organization, time management, communication, and interpersonal skills are required.
- Perform QC testing in support of raw material, in-process, intermediate, and drug substance testing.
- Ensure that all samples are tested and documented in accordance with the appropriate cGMP, Regulatory, and Company requirements and in a timely manner.
- Coordinate laboratory maintenance activities, including the monitoring of supply inventories and equipment calibration status and re-qualification.
- Establish stability protocols and ensure that stability data supports product re-tests and storage conditions.
- Ensure the maintenance and calibration procedures and checks of critical equipment are effective.
- Independently draft study protocols and data summary reports.
- Independently draft and revise written test methods as required.
- Independently perform test method optimization, qualification, and validation as required.
- Independently identify and investigate Out of specification and non-conformities with procedures or cGMP and report them to senior management in a timely manner
- Ensure that the necessary qualifications / validations are carried out in accordance with approved protocols.
- Support the organization in maintaining a work environment focused on quality and that fosters learning, respect, open communication, collaboration, integration, and teamwork.