Specialist Manufacturing at BioPharma Consulting JAD Group

Juncos, , Puerto Rico -

Full Time

Start Date

Immediate

Expiry Date

22 Jun, 26

Salary

0.0

Posted On

24 Mar, 26

Experience

5 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Process Validation, Non-conformances, Troubleshooting, Root Cause Analysis, CAPAs, Change Control, Process Improvement, Data Analysis, Training Material Development, Regulatory Inspections, NPI Support, Technical Writing, Project Management, Quality Systems, TrackWise, Veeva

Industry

Biotechnology Research

Description

With minimal supervision, the Specialist Manufacturing supports the execution of manufacturing and quality systems, including non-conformances, process validation, procedures, training, and new product introductions (NPI). This role applies process, operational, and scientific expertise along with compliance knowledge and analytical troubleshooting skills to support manufacturing operations. The specialist may serve as a primary process owner for defined systems and assist with more complex process ownership responsibilities. Key Responsibilities Initiate, revise, and approve manufacturing procedures; ensure alignment with current operations. Serve as document owner for assigned procedures. Monitor process performance through floor observation and data analysis. Identify, evaluate, and implement process improvements. Provide technical troubleshooting support. Assist in development of training materials and support delivery of technical training. Support establishment of process monitoring parameters and control limits. Collect and analyze process monitoring data. Assist in deviation assessments and trend evaluations. Support timely execution of quarterly process monitoring reports. Ensure timely triage of non-conformances within established goals. Author investigation reports and support root cause analysis. Execute corrective and preventive actions (CAPAs). Manage closure of NC/CAPA records within required timelines. Monitor and communicate incident trends. Review equipment/system investigations and support trend analysis. Assist in development of process validation protocols and reports. Support execution of validation activities. Collect and analyze validation data. Participate in regulatory inspections and audits as needed. Support NPI activities by assessing documentation, materials, training, and equipment needs. Assist with process and equipment modification projects. Support prioritization, justification, and implementation of changes. Support change control activities and assist manufacturing change owners with CCRB packages. Participate in special projects and continuous improvement initiatives. Support cross-functional project execution. Doctorate, OR Master’s degree + 2 years of Manufacturing Operations experience, OR Bachelor’s degree + 4 years of Manufacturing Operations experience, OR Associate’s degree + 8 years of Manufacturing Operations experience, OR High School Diploma/GED + 10 years of Manufacturing Operations experience Preferred Qualifications Experience in biotech or pharmaceutical manufacturing, process development, or quality assurance. Demonstrated experience with: Deviations, CAPAs, and Change Controls Quality systems and compliance Root cause analysis and structured problem solving Experience owning and managing Change Controls. Strong project management and quality management experience. Strong written and verbal communication skills (English). Experience with: TrackWise, Veeva, or similar quality systems SAP (ERP systems) Microsoft Office Suite (Word, Excel, PowerPoint, Project, Teams, Outlook) Contract Position 5-months

Responsibilities

This role supports the execution of manufacturing and quality systems, including managing non-conformances, process validation, procedures, and new product introductions with minimal supervision. Key duties involve serving as a process owner, monitoring process performance, identifying improvements, and providing technical troubleshooting support.