Specialist Manufacturing 3026213
Title: Specialist Manufacturing โ 3026213 ๐น
Location: Juncos, PR
Work Type: 100% Onsite โ Administrative Shift
Contract Duration: Approximately 5 months
Open Positions: 1
Summary
ProQuality Network is seeking a Specialist Manufacturing to support manufacturing and quality systems, including non-conformances, process validation, procedures, training, and new product introductions. With minimal supervision, this role applies technical expertise, operational knowledge, and troubleshooting skills to ensure compliance with industry standards. The selected candidate may also serve as a process owner for support systems.
Key Responsibilities
Process Expertise & Documentation
- Develop and update manufacturing procedures to reflect current operations.
- Serve as a document owner, ensuring compliance and accuracy.
- Assess process performance by reviewing operational data and identifying improvement opportunities.
- Provide troubleshooting support to manufacturing operations.
- Assist in training development and delivery for technical aspects of the process.
Process Monitoring & Compliance
- Support the establishment and monitoring of process control parameters.
- Collect and analyze process monitoring data, assisting in deviation assessments.
- Ensure timely execution of process monitoring quarterly reports.
Non-Conformance & CAPA Management
- Ensure all non-conformances are triaged within established timelines.
- Author and execute investigation reports and corrective actions.
- Manage NC/CAPA closure within designated timeframes.
- Track and analyze incident trends to improve processes.
- Review Root Cause Analysis (RCA) investigations and support trend evaluations.
Process Validation
- Assist in developing process validation protocols and reports.
- Support the execution and data analysis of process validation activities.
Regulatory Compliance
- May participate in regulatory inspections and audits as required.
New Product Introductions (NPI) & Process Modifications
- Participate in NPI assessments for documentation, training, and equipment modifications.
- Evaluate, prioritize, and support the implementation of process/equipment modifications.
Change Control & Project Management
- Assist with Change Control Review Board (CCRB) packages affecting processes.
- Support special projects and initiatives as assigned.
- Other duties may be assigned as needed.
Required Education & Experience
๐ Doctorate degree OR
๐ Master's degree + 3 years of Manufacturing Operations experience OR
๐ Bachelorโs degree + 5 years of Manufacturing Operations experience OR
๐ Associateโs degree + 10 years of Manufacturing Operations experience OR
๐ High School Diploma/GED + 12 years of Manufacturing Operations experience.
Preferred Qualifications & Skills
โ๏ธ Educational background in Life Sciences and/or Engineering.
โ๏ธ Strong technical writing skills and proficiency in English & Spanish.
โ๏ธ Experience with Root Cause Analysis & CAPA management.
โ๏ธ Knowledge of bio-processing unit operations & regulatory compliance.
โ๏ธ Understanding of GMP documentation & standard manufacturing procedures.
โ๏ธ Strong communication and collaboration skills with technical and management teams.
โ๏ธ Proficiency in project management and data analysis.
๐ข Interested candidates are encouraged to apply by submitting an updated resume through the job description link !