Manufacturing Specialist Job at ProQualityNetwork in Juncos

Job Opportunity: Specialist Manufacturing (33688)

Location: Juncos, PR (100% On-site)

Shift: 8:00 am - 5:00 pm (Flexible for weekends)

Duration: Approximately 6 months

Positions Available: 1

Summary:

With minimal supervision, support the execution of manufacturing and quality systems, including non-conformances, process validation, procedures, training, and new product introductions. Apply process, operational, and scientific expertise, along with basic compliance knowledge, and strong analytical and troubleshooting skills, to support manufacturing operations. May serve as primary production process owner for support systems and assist with more complex process responsibilities.

Educational & Experience Requirements:

Education:

• Doctorate degree
• OR Masters degree with 3 years of manufacturing experience
• OR Bachelors degree with 5 years of manufacturing experience
• OR Associates degree with 10 years of manufacturing experience
• OR High school diploma/GED with 12 years of manufacturing experience

Manager Preferred Experience:

• Change Control
• CAPA
• VAPA EV
• Deviations
• Documentation handling

Key Responsibilities:

Applied Process Expertise

• Initiate, revise, and approve manufacturing procedures, ensuring all procedures reflect current operations. Serve as a document owner.
• Assess process performance by observation and review of performance data; identify and implement solutions for process improvement.
• Provide troubleshooting support.
• Assist in generating training materials and provide training on scientific or technical process aspects.

Process Monitoring

• Support establishment of process monitoring parameters and control limits.
• Collect and monitor process data, assisting in assessing deviations.
• Support timely execution of quarterly process monitoring reports.

Non-Conformance and CAPA

• Ensure all non-conformances are triaged within established timelines.
• Author investigation reports and execute corrective actions.
• Manage NC/CAPA closures, monitor trends, and review equipment/system Root Cause Analyses.

Process Validation

• Assist in creating and executing process validation protocols and reports.
• Support data collection and analysis for validation purposes.

Regulatory

• May participate in regulatory inspections as needed.

New Product Introductions & Process/Equipment Modifications

• Participate in the NPI process to assess requirements for documentation, materials, training, and equipment modifications.
• Assist with prioritization, justification, and project management support for process or equipment modification projects.

Change Control

• Assist manufacturing change owners with CCRB packages affecting processes.
• Manage change control records.

Projects and Initiatives

• Participate in the assessment and implementation of special projects or initiatives as needed.

Competencies/Skills:

Detailed technical understanding of bioprocessing unit operations

Skilled in GMP production operations

Regulatory knowledge and compliance experience

Ability to lead and participate in cross-functional teams

Strong communication, collaboration, organizational, and technical writing skills

Basic project management skills

Knowledge of control charting

Join a dynamic and innovative environment where your skills and experience will make a difference!

Ready to take the next step in your career? We invite all qualified candidates to apply inside the job description were it says "APPLY HERE" with an updated resume. Don't miss this exciting opportunity to make an impact!