Manufacturing Specialist-35599
ProQuality Network
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Job summary
ProQuality Network is seeking a Manufacturing Specialist in Juncos, Puerto Rico, to support manufacturing operations with minimal supervision on a 5‑month on-site contract. You will execute and support manufacturing and quality systems, including non-conformances, process validation, procedures, training, and new product introductions.
This role requires strong technical knowledge, analytical thinking, troubleshooting skills, and a solid understanding of GMP, with collaboration across
Qualifications
- Doctorate degree or equivalent as one of the education paths.
- Bachelor's degree with 4+ years of Manufacturing Operations experience.
- Associate degree with 8+ years of Manufacturing Operations experience.
- High School Diploma/GED with 10+ years of Manufacturing Operations experience.
Responsibilities
- Initiate, revise, and approve manufacturing procedures, ensuring documentation reflects current operations.
- Serve as the document owner for assigned manufacturing procedures.
- Monitor manufacturing processes through floor observations and performance data analysis.
- Identify opportunities for process improvements and implement solutions.
- Provide technical troubleshooting support to manufacturing operations.
- Assist in developing training materials and deliver process training.
Skills
Education
Tools
Job description
Juncos, Puerto Rico
On-site | Administrative Shift
Availability to work different shifts and weekends based on business needs.
Contract: 5 months
Important Notice: This opportunity is available only to individual candidates. Third-party agencies, staffing firms, vendors, and Corp-to-Corp (C2C) arrangements will not be considered for this position.
Our client is seeking a Manufacturing Specialist to support manufacturing operations with minimal supervision. The selected candidate will be responsible for executing and supporting manufacturing and quality systems, including non-conformances, process validation, procedures, training, and new product introductions.
This role requires strong technical knowledge, analytical thinking, troubleshooting skills, and a solid understanding of manufacturing compliance. The Manufacturing Specialist may also serve as the primary process owner for assigned manufacturing support systems while assisting with more complex manufacturing processes.
- Initiate, revise, and approve manufacturing procedures, ensuring documentation accurately reflects current operations.
- Serve as the document owner for assigned manufacturing procedures.
- Monitor manufacturing processes through floor observations and performance data analysis.
- Identify opportunities for process improvements and implement effective solutions.
- Provide technical troubleshooting support to manufacturing operations.
- Assist in developing training materials and deliver technical or scientific process training as needed.
- Support the establishment of process monitoring parameters and control limits.
- Collect and analyze process monitoring data.
- Assist in the evaluation of process deviations.
- Support the timely preparation and completion of quarterly process monitoring reports.
- Ensure all non-conformances are triaged within established timelines.
- Author investigation reports for non-conformance events.
- Execute corrective and preventive actions (CAPAs).
- Manage NC/CAPA activities through closure within established deadlines.
- Monitor, analyze, and communicate process and incident trends.
- Review Root Cause Analysis investigations for equipment and systems and support trend evaluations.
- Assist in the development of process validation protocols and reports.
- Support the execution of process validation activities.
- Collect, analyze, and document process validation data.
- Participate in regulatory inspections, audits, and compliance activities.
- Support New Product Introductions (NPI) by assessing documentation, training, material, and equipment requirements.
- Assist in evaluating, prioritizing, and implementing process and equipment modification projects.
- Provide project management support for manufacturing improvement initiatives.
- Support Manufacturing Change Owners with Change Control Review Board (CCRB) packages impacting manufacturing processes.
- Participate in special projects and continuous improvement initiatives.
- Perform additional duties as assigned.
Candidates must meet one of the following education and experience combinations:
- Doctorate degree
- Master's degree with 2+ years of Manufacturing Operations experience
- Bachelor's degree with 4+ years of Manufacturing Operations experience
- Associate degree with 8+ years of Manufacturing Operations experience
- High School Diploma/GED with 10+ years of Manufacturing Operations experience
- Experience with bioprocessing unit operations.
- Strong understanding of GMP (Good Manufacturing Practices) production operations.
- Knowledge of process validation and manufacturing process monitoring.
- Experience managing non-conformances, investigations, and CAPAs.
- Familiarity with regulatory requirements in a regulated manufacturing environment.
- Knowledge of Root Cause Analysis methodologies, including:
- Fishbone Diagram
- 5 Whys
- Kepner-Tregoe
- Six Boxes
- Experience with Lean Manufacturing principles.
- Proficiency in Good Documentation Practices (GDP).
- Experience working with manufacturing and quality systems, including:
- TrackWise
- Veeva
- MES
- SmartSheet
- Power BI
- Spotfire
- CDOCS
- Process Monitoring Platforms
- Microsoft Copilot
- ChatGPT
- Basic knowledge of statistical process control and control charting.
- Basic project management skills.
- Strong technical writing and presentation skills.
- Excellent verbal and written communication skills in both English and Spanish.
- Strong organizational and analytical skills.
- Ability to collaborate effectively with cross-functional teams, including Manufacturing, Process Development, Quality, and Technical Operations.
- Excellent interpersonal and teamwork skills.
- Ability to work independently with minimal supervision.
- Ability to perform effectively in a fast-paced, high-volume environment.
- Willingness to work extended hours, alternate shifts, weekends, and overtime as business needs require.
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