Manufacturing Operations Specialist
hace 2 días
Biopharma Consulting Jad Group is seeking an experienced Manufacturing Operations Specialist to join our team. This role offers a competitive salary of $80,000-$110,000 per year.
Job Description:
We are looking for a highly skilled professional with expertise in bioprocessing unit operations and GMP production. The ideal candidate will have a strong understanding of regulatory requirements and inspection processes. In this role, you will be responsible for supporting the execution of manufacturing and quality systems, including non-conformances, process validation, procedures, training, and new product introductions.
You will apply process expertise, compliance knowledge, and analytical skills to support manufacturing operations effectively. This position may act as the primary process owner for specific systems and assist with more complex process ownership responsibilities.
Key Responsibilities:
- Initiate, revise, and approve manufacturing procedures to ensure alignment with current operations.
- Serve as a document owner for manufacturing procedures.
- Evaluate floor operations and performance data to identify and implement process improvements.
- Provide troubleshooting support and assist in training material development.
- Support the establishment and assessment of process monitoring parameters and control limits.
- Collect process monitoring data and assist with quarterly report execution.
- Ensure timely triage of non-conformances within established goals.
- Author investigation reports and execute corrective actions.
- Manage NC/CAPA closure within designated timelines and monitor trends.
- Support root cause analysis (RCA) and trend evaluations for equipment/system investigations.
- Assist with the creation and execution of process validation protocols and reports.
- Collect and analyze process validation data.
- Participate in regulatory inspections as needed.
- Assess documentation, materials, training, and equipment modification requirements for NPIs.
- Provide project management support for process and equipment modifications.
- Assist in managing Change Control Review Board (CCRB) packages that impact manufacturing processes.
- Contribute to special projects and process improvement initiatives as assigned.
Requirements and Qualifications:
To be successful in this role, you should have a 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. A Bachelor's Degree in Sciences or Engineering is preferred.
Experience with manufacturing processes, documentation revision, CAPA management, and change control systems is highly valued. If you are passionate about biopharmaceutical manufacturing and possess excellent technical writing and organizational skills, we encourage you to apply.
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