Specialist Manufacturing ProQN922

ProQuality Network; Juncos (PR); On-site; USD 85,000 - 110,000; Full time

Job summary

ProQuality Network in Juncos, Puerto Rico, is seeking a Specialist Manufacturing to support manufacturing and quality systems on-site for a 1-year contract. The role focuses on NCRs, CAPA, process validation, NPI, and change control, with responsibilities spanning document ownership, procedure approvals, and cross-functional collaboration.

Responsibilities include monitoring process performance, developing training materials, and participating in regulatory inspections as needed.

Qualifications

• Master’s degree with 3 years of manufacturing ops experience.
• Bachelor’s degree with 5 years of manufacturing ops experience.
• Associate degree with 10 years of manufacturing ops experience.
• High school diploma or GED with 12 years of manufacturing ops experience.
• Detailed technical understanding of bioprocessing unit operations.
• Proficiency in GMP production operations.
• Regulatory knowledge and experience with regulatory interactions.
• Ability to lead cross-functional teams.
• Ability to communicate with technical and management staff across groups.
• Strong organizational, technical writing, and presentation skills.

Responsibilities

• Initiate, revise, and approve manufacturing procedures reflecting current operations.
• Serve as a document owner.
• Assess process performance through floor observations and data reviews.
• Evaluate and implement process improvements.
• Assist in developing training materials and may provide training on process aspects.
• Support process monitoring and quarterly reports.
• Assist in process validation protocols and reports.
• May participate in regulatory inspections.
• Provide NPI process support for documentation, material, training, and equipment modifications.
• Provide implementation and project management support for modification projects.
• Assist with Change Control Review Board packages.

Skills

Manufacturing operations

GMP production operations

Regulatory knowledge

Cross-functional collaboration

Technical writing

Education

Master’s degree

Bachelor’s degree

Associate degree

High school diploma or GED

Job description

Title: Specialist Manufacturing ProQN922

Location: Juncos, Puerto Rico (Puerto Rico residents only)

Work Arrangement: On-site, Administrative Shift

Number of Positions: 3

1 year contract

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, basic compliance knowledge, and analytical and troubleshooting skills to support manufacturing operations. May serve as the primary production process owner for process support systems and assist with process ownership responsibilities for more complex process systems.

Preferred Qualifications

• Manufacturing operations experience.
• Experience with CAPAs, Change Control (CC), Risk Assessments, and CDOC Editor.

Functions and Responsibilities

Applied Process Expertise

• Initiate, revise, and approve manufacturing procedures, ensuring they reflect current operations.
• Serve as a document owner.
• Assess process performance through floor observations and performance data reviews.
• Evaluate, plan, and implement solutions to process improvement opportunities.
• Assist in developing training materials and may provide training on scientific or technical aspects of the process.

Process Monitoring

• Support the establishment of process monitoring parameters and control limits.
• Collect process monitoring data and support deviation assessments.
• Support the timely execution of quarterly process monitoring reports.

Non-Conformance and CAPA

• Ensure non-conformances are triaged within established timelines.
• Execute corrective actions.
• Manage non-conformance (NC) and CAPA closures within established timelines.
• Monitor and communicate incident trends.
• Review equipment and system Root Cause Analysis (RCA) investigations and support trend evaluations.

Process Validation

• Assist in developing process validation protocols and reports.
• Assist with process validation execution.
• Support the collection and analysis of process validation data.

Regulatory

• May participate in regulatory inspections.

New Product Introductions and Process or Equipment Modifications

• Participate in the New Product Introduction (NPI) process to assess documentation, material, training, and equipment modification requirements.
• Assess, prioritize, and justify process or equipment modification projects.
• Provide implementation and project management support for these projects.

Change Control

• Assist the manufacturing change owner with Change Control Review Board (CCRB) packages that impact the process.

Projects and Initiatives

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

Other functions may be assigned.

Education and Experience Requirements

Candidates must meet one of the following requirements:

• Master’s degree and 3 years of manufacturing operations experience.
• Bachelor’s degree and 5 years of manufacturing operations experience.
• Associate degree and 10 years of manufacturing operations experience.
• High school diploma or GED and 12 years of manufacturing operations experience.

Competencies and Skills

• Detailed technical understanding of bioprocessing unit operations.
• Proficiency in GMP production operations.
• Regulatory knowledge and experience with regulatory interactions.
• Ability to participate in and help lead cross-functional teams.
• Ability to communicate and collaborate with technical and management staff across manufacturing, process development, and quality.
• Strong organizational, technical writing, and presentation skills.