6292 QC Associate II
The QC Process Monitoring (QCPM) Associate II is responsible for coordinating and monitoring quality system attributes of QC laboratories, provide technical expertise and provide support for routine make, assess, and release (MAR) operations.
The candidate should be able to complete work under minimal supervision, in accordance with cGMP guidelines, and have fluency with analytical and/or microbiological methodology.
He/she is to demonstrate efficiency while executing objectives that include but are not limited to the following: quality system investigations, metrics and trending, training, lab maintenance systems, equipment management, document management, coordination of outsourced testing and blanket PO management.
The Associate II is accountable for maintaining all aspects of QCPM laboratory support activities.
They must be able to interpret results against defined criteria and apply a degree of critical thinking as a subject matter expert (SME).
He/she must demonstrate an ability to compare a wide range of data sources against trend reports and contribute to proactive troubleshooting of issues and/or atypical results.
In addition, the candidate should be detail-oriented, exhibit effective time management and communication skills, and be able to work in a team-oriented culture of open feedback.
The candidate should also be able to anticipate and implement solutions that actively prevent and/or remove obstacles related to ongoing issues and allow for continuous improvement.
Key issues in all work assignments must be identified regardless of complexity.
The chosen candidate is expected to follow and be proficient in knowledge and theory behind SOPs, understand the rationale behind requirements, apply consistent critical thinking skills to routine and non-routine work, and facilitate decision-making forums that involve suitable SMEs.
He/she should possess the ability to independently recognize, initiate, and investigate any deviations from procedures, and be versed in fully supporting reasoning for conclusions.
Information must be appropriately communicated and escalated to proper audiences.
Attendance at team meetings with some facilitation of discussions is essential, providing focus and accounting for the impact of department initiatives to the greater organization.
The chosen candidate will be proactive and invested in his/her role and engage with colleagues to foster mutual respect and ensure the collective team environment carries an overall positive and productive atmosphere.
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 an investigational mindset and critical thinking skills to less experienced staff.
Perform gap assessments of quality systems and processes in accordance with updates to quality and method regulations or guidance documents.
Routinely monitor lab system or method performance and lead the implementation of optimization and continuous improvement projects.
Apply proactive communication upon occurrence of issues or genesis of improvement concepts. Represent department needs as part of cross-functional teams while fostering collaboration and consensus in the deciphering of paths forward.
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.
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.