Summary: We are seeking a Manufacturing/Quality Support Specialist to assist with manufacturing and quality systems in a bioprocessing environment, including non-conformances, process validation, and new product introductions.
The role requires strong analytical, operational, and scientific expertise, as well as basic compliance knowledge and troubleshooting skills to maintain and improve manufacturing operations.
The ideal candidate is proactive, detail-oriented, and skilled at collaboration across technical and management teams.
Key Responsibilities: Process Expertise: Serve as a document owner by initiating, revising, and approving manufacturing procedures.
Assess floor operations and performance data to identify and implement process improvements.
Provide troubleshooting support and assist in developing training materials for technical aspects of processes.
Process Monitoring: Support establishment of process parameters and control limits; collect data to monitor processes and assess deviations.
Assist with timely preparation of process monitoring reports.
Non-Conformance & CAPA Management: Triage and document non-conformances and CAPA within established timelines.
Author investigation reports, execute corrective actions, and manage NC/CAPA closures.
Support root cause analysis evaluations and trend monitoring for continuous improvement.
Process Validation: Assist in creating and executing process validation protocols and reports.
Support data collection and analysis for validation activities.
Regulatory Compliance: Participate in regulatory inspections as needed to ensure all protocols meet compliance standards.
New Product Introductions & Process/Equipment Modifications: Contribute to NPI efforts by assessing requirements for documentation, materials, and training.
Provide project management support for process and equipment modifications.
Change Control and Special Projects: Assist in change control management, supporting CCRB packages impacting processes.
Engage in special projects or initiatives as assigned.
Skills and Competencies: In-depth understanding of bioprocessing unit operations and GMP production.
Strong organizational, technical writing, and presentation skills.
Basic project management and control charting knowledge.
Ability to work effectively in cross-functional teams, communicate with stakeholders, and lead initiatives.
Proficiency in regulatory compliance processes and change control management.
Requirements Qualifications: Education: Doctorate degree, or Master's degree with 3 years of experience, or Bachelor's degree with 5 years, or Associate's degree with 10 years, or high school diploma/GED with 12 years of Manufacturing Operations experience.
Preferred Experience: Experience with facilities change control and decommissioning processes.
Familiarity with TrackWise and Veeva systems for documentation and quality management.
Shift: 8:00 AM - 5:00 PM