Quality and compliance specialist- Night Shift
Quality and Compliance Specialist
Company is seeking a qualified Quality and Compliance Specialist to join our Quality Control team. The Quality and Compliance Specialist is responsible for the review of the laboratory raw data, procedures and reports to ensure methods, protocols and other procedures were properly followed, results are analytically accurate and correct, and that all documentation meets GMP and data integrity standards. They are responsible for the release of some GMP materials.
- Review IPC, raw materials, intermediates, and finished products analytical data, as well as cleaning validation/verification data according to cGMP, GDP, in a timely manner.
- Release of starting materials, raw materials, and cleaning validations/verifications for GMP manufacturing
- Interface with their supervisor, the analytical group(s) and QA on a daily basis.
- Review of deviations for accuracy, completeness and compliance to data integrity, written procedures, and cGMP regulations
- Document review includes review of sample preparation, equipment set-up, and test results in laboratory notebooks or other appropriate test record forms, and electronic data and audit trails
- Review of a variety of data types including HPLC, GC, KF, IR, XRPD, ICP, TGA, DSC, and wet chemistry testing
- Review of reports for accuracy and completeness. Reports may include but not limited to: method validation reports, stability reports, lab equipment and instrumentation Calibration and Preventive Maintenance (PM) Reports, etc.
- Perform and or support lab investigations (e.g. OOS, deviations, CAPAs)
- Assist in the preparation of new or revised documentation as required.
- Participate in the implementation of continuous improvement initiatives as they relate to quality activities (e.g., introduction of new technology and automation with respect to data acquisition, electronic review, quality management systems, LIMS, etc.)
- Revise via change control documentation as required
- Perform other related assignments and projects as required
- Bachelor’s degree in Chemistry, Biochemistry or related field.
- Minimum two (2) to five (5) years of experience in using HPLC, GC, and/or related analytical techniques. QC data review experience a plus.
- Knowledge of ECM OpenLab, SAP, Trackwise, LIMS a plus.
- Technical Writing Experience
- Minimum two (2) years of GMP laboratory experience.