9138 QC Associate II
Ensure quality systems are in place and followed, and execute principal investigation of deviations, LIRs, excursions, adverse trend and child or assessment records as needed.
Evaluate routine assay validity, calculate and summarize results, analyze data per expectations or specifications.
Assist with compilation and verification of trend reports.
Aid in the preparation of monthly and quarterly reports for in-process and environmental monitoring data, review and analysis of testing trends and Microbial Identifications.
Manage lab systems (MODA / LIMS) such as builds and upgrades for continued functionality. Efforts include the resolution of MODA / LIMS discrepancies and approval of MODA / LIMS entries.
Facilitate laboratory equipment maintenance such as PM, calibration and equipment status. Coordinate CMMS processes such as work orders and calibration due dates.
Identify, vet and own proper CAPA as the result of adverse trends or discrepancies and, if applicable, sequential Effectiveness Check strategy.
Manage and facilitate lab document revisions to ensure on-time completion.
Support implementation of system improvements and procedural revisions, with emphasis on increasing laboratory efficiencies and safety.
Manage contract lab tests and review of data from these labs.
Create blanket purchase orders based on the needs of the QC labs.
Qualify as trainer for a variety of responsibilities. Provide training, troubleshooting and coaching on investigational mindset and critical thinking skills to less experienced staff.
B.S. degree, or equivalent, in a biological or biochemical science and at least 6 years of experience in a pharmaceutical laboratory, with at least 3 years as part of a QC organization.
Detailed knowledge of quality management systems, current Good Manufacturing Practices, expertise with QC principles and compliance requirements.
Writing deviations, laboratory investigations, change controls, and scientific reports is preferred.
Demonstrated working knowledge and critical thinking with respect to certified functional activities, with subject matter expertise on several technical modules or quality management systems.
Excellent documentation, written and verbal communication skills are essential.
Must possess the ability to perform routine and non-routine tasks under minimal supervision while modeling initiative, self-direction, objectivity, and team advocacy.
Ability and willingness to provide input to the entire group, with proficiency in both facilitating active and open discussion and laying groundwork for logical decision making.
Working knowledge of cGMP regulations pertaining to test result disposition, stability protocol generation and execution and critical reagent program management, is desired.
Computer literacy is required, proficiency with Microsoft Word and Excel is essential, experience with Microsoft PowerPoint, Access, Project and/or Visio is desired.
Expertise with laboratory software functions, such as within MODA or LIMS, is optimal.
Must have a quality service attitude and focus, exhibit flexibility and willingness to work additional hours to meet production or laboratory process requirements.
PLEASE NOTE: Our client has mandated COVID-19 vaccination for their workforce, all external personnel providing services to our client are required to comply with this requirement.