7432 QC Associate

Duties:
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 forums that involve suitable SMEs.
They 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 (investigation of deviations, LIRs, alert/action excursions, adverse trend and facility child investigations).
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.
Coordinate troubleshooting efforts of instrumentation or reagents through hypothesis testing, laboratory notebook studies and communication with vendor technical support.
Identify proper CAPA as the result of adverse trends or discrepancies plus, if applicable, sequential Effectiveness Check strategy, and provide ownership whenever necessary.
Manage and facilitate lab documents 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.
Act as training coordinator for QC analysts to maintain compliance.
Perform gap assessments of methods and processes in accordance with updates to quality and method regulations or guidance documents.
Support implementation of optimization and continuous improvement projects.
Extend subject matter expertise into the development of investigational, comparability study, validation or method transfer protocols.
Provide support to validation or special laboratory studies with data compilation, verification and analysis.
Assist in the composition of technical and/or validation reports.
Perform other responsibilities as deemed necessary.

Skills:
Candidate must be a motivated employee capable of working in a fast-paced environment to produce quality and timely results.
Strong time management and organizational skills.
Experience managing projects and processes.
Strong people skills.
Experience with meeting organization and facilitation.
Practiced in technical training element and program deployment.
Ability to foster a team-oriented environment.
Experience authoring and reviewing SOPs, test records, work instructions, OJTs, and other controlled documents.
Detailed knowledge of quality management systems, current Good Manufacturing Practices, expertise with QC principles and compliance requirements.
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.
Fluency with the evaluation of baseline statistics with some exposure to tools offered by advanced software such as JMP or Microsoft Power Pivot.
Must have a quality service attitude and focus, exhibit flexibility and willingness to work additional hours to meet production or laboratory process requirements.

Education:
B.S. degree, or equivalent, in a biological or biochemical science and at least 4 years of experience in a pharmaceutical laboratory, with at least 2 years as part of a QC organization.