BioPharma Consulting JAD Group is currently seeking a Specialist Manufacturing to join our team.
As a Specialist Manufacturing, you will play a vital role in supporting the execution of manufacturing and quality systems.
KEY RESPONSIBILITIES Applied Process Expertise Initiate, revise, and approve manufacturing procedures, ensuring they reflect current operations.
Serve as a document owner.
Assess process performance through floor operations observation and performance data review.
Plan and implement solutions for process improvements.
Provide troubleshooting support to resolve production issues.
Assist in generating training materials and provide training on scientific or technical aspects of the process.
Process Monitoring Support the establishment of process monitoring parameters and control limits.
Collect and assess process-monitoring data.
Assist in the timely execution of process monitoring quarterly reports.
Non-Conformance and CAPA Management Ensure timely triage of non-conformances within established goals.
Author investigation reports and manage the execution of corrective actions.
Oversee NC/CAPA closure within established timelines.
Monitor and communicate incident trends.
Review equipment/system Root Cause Analysis investigations and support trend evaluations.
Process Validation Assist with the creation and execution of process validation protocols and reports.
Support data collection and analysis during process validation.
Regulatory Compliance Participate in regulatory inspections as required.
New Product Introductions & Process/Equipment Modifications Participate in the NPI process, assessing requirements for documentation, materials, training, and equipment modifications.
Provide project management support for process or equipment modification projects, including assessment, prioritization, and implementation.
Change Control Assist the manufacturing change owner in managing CCRB packages that impact the process.
Projects and Initiatives Participate in the assessment or implementation of special projects or initiatives.
Additional responsibilities may be assigned as needed.
COMPETENCIES & SKILLS In-depth technical understanding of bioprocessing unit operations.
Proficiency in GMP production operations.
Knowledge of regulatory requirements and experience with regulatory interactions.
Ability to lead and participate in cross-functional teams.
Strong communication and collaboration skills with technical and management staff across manufacturing, process development, and quality.
Excellent organizational, technical writing, and presentation skills.
Basic project management skills and knowledge of control charting.
PREFERRED QUALIFICATIONS Experience in procedure revision and documentation.
Familiarity with QMTS Trackwise, CAPA management, and manufacturing process audits.
Laboratory knowledge and experience.
Requirements EDUCATION & EXPERIENCE Doctorate degree OR Master's degree with 3 years of Manufacturing Operations experience OR Bachelor's degree with 5 years of Manufacturing Operations experience OR Associate's degree with 10 years of Manufacturing Operations experience OR High school diploma / GED with 12 years of Manufacturing Operations experience.
WORK SCHEDULE Shift: 8:00 AM to 5:00 PM
