Manufacturing Specialist - Regulated Industry (3516867)

ProQuality Network; United States; On-site; USD 65,000 - 95,000; Part time

Benefits offered by this job

Remote work option

6-month contract

Job summary

ProQuality Network seeks a Manufacturing Specialist in a regulated environment on a contract basis. The role supports manufacturing and quality systems, including non-conformance management, process validation, and new product introductions.

The candidate applies scientific and compliance expertise with minimal supervision, potentially serving as a process owner for select systems. The position emphasizes strong documentation, data analysis, and cross-functional collaboration, with

Qualifications

• Educational background in Science or Industrial Engineering preferred.
• Experience in manufacturing, process development, or quality assurance within biotech or pharmaceutical industry.
• Experience in compliance, problem-solving, project management and quality systems.

Responsibilities

• Initiate, revise, and approve manufacturing procedures; ensure alignment with current operations.
• Serve as document owner for assigned procedures.
• Assess process performance through floor observations and data review.
• Identify, plan, and implement process improvement initiatives.
• Provide technical troubleshooting support.
• Assist in the development of training materials and delivery of technical training.
• Support establishment of process monitoring parameters and control limits.
• Collect and analyze process monitoring data.
• Support deviation assessments and timely completion of quarterly process monitoring reports.
• Ensure timely triage of non-conformances and author investigation reports.
• Manage NC/CAPA closure within timelines and monitor incident data.
• Assist in development of process validation protocols and reports.
• Support regulatory inspections and NPI activities; assess documentation, materials, training, and equipment requirements.

Skills

Quality management

Cross-functional teams

English communication

Data analysis

Microsoft Office

TrackWise/Veeva

SAP ERP

Process validation

Non-conformance management

CAPA management

Documentation writing

Education

Master’s degree in Science or related

Bachelor’s degree in Science/Engineering

Associate degree in related field

High School Diploma/GED

Tools

SAP

TrackWise

Veeva Systems

Job description

Manufacturing Specialist - Regulated Industry (3516867)

Title: Specialist Manufacturing – Regulated Industry (3516867)

(Open to residents of Puerto Rico)

Work Arrangement: Virtual/Remote (availability to work onsite as needed)

Work Schedule: Administrative Shift

Employment Type: Contract

Duration: Approximately six (6) months

Positions Available: 1

Position Summary

Our client is seeking a Specialist Manufacturing – Regulated Industry to support manufacturing and quality systems with minimal supervision. This role will contribute to the execution of non-conformance management, process validation, procedure development, training, and new product introductions. The selected candidate will apply process, operational, scientific, and compliance expertise to support manufacturing operations and may serve as a primary production process owner for select systems.

Preferred Qualifications

• Educational background in Science or Industrial Engineering preferred
• Experience in manufacturing, process development, or quality assurance within the biotech or pharmaceutical industry, with progressive responsibility
• Demonstrated experience in compliance, problem‑solving, critical thinking, project management, and quality systems

Professional Skills & Experience

• Project and/or Quality Management experience with the ability to coordinate and actively participate in cross‑functional teams
• Proven ability to manage multiple, competing priorities in a fast-paced environment with minimal direction
• Strong written and verbal communication skills in English, including technical writing and presentations
• Ability to work autonomously, prioritize tasks, meet deadlines, and present data clearly and logically
• Capability to navigate ambiguity and apply structured problem‑solving methodologies
• Proficiency with Microsoft Office tools (Word, Excel, PowerPoint, Project, Teams, Outlook)
• Experience managing quality records such as deviations, CAPAs, change controls, and supplier investigations using TrackWise, Veeva, or comparable quality systems
• Experience executing transactions in SAP (ERP) systems
• Strong negotiation and influencing skills with peers, leadership, suppliers, and cross‑functional stakeholders
• Ability to maintain effective working relationships in a remote environment

Key Responsibilities

Applied Process Expertise

• Initiate, revise, and approve manufacturing procedures; ensure alignment with current operations
• Serve as document owner for assigned procedures
• Assess process performance through floor observations and data review
• Identify, plan, and implement process improvement initiatives
• Provide technical troubleshooting support
• Assist in the development of training materials and delivery of technical training

Process Monitoring

• Support establishment of process monitoring parameters and control limits
• Collect and analyze process monitoring data
• Support deviation assessments and timely completion of quarterly process monitoring reports

Non‑Conformance & CAPA Management

• Ensure timely triage of all non‑conformances
• Author investigation reports and execute corrective actions
• Manage NC/CAPA closure within established timelines
• Monitor, trend, and communicate incident data
• Review equipment and system Root Cause Analysis investigations and support trend analysis

Process Validation

• Assist in the development of process validation protocols and reports
• Support execution of validation activities
• Collect, analyze, and interpret process validation data

Regulatory & Compliance Support

• Participate in regulatory inspections, new product introductions, and process or equipment modifications as needed
• Support NPI activities, including assessment of documentation, materials, training, and equipment requirements
• Assess, prioritize, and support implementation of process or equipment modification projects

Change Control

• Support manufacturing change owners with Change Control Review Board (CCRB) packages impacting processes

Projects & Initiatives

• Participate in special projects and continuous improvement initiatives
• Perform other related duties as assigned

Education Requirements

• Master’s degree plus 2 years of manufacturing operations experience OR
• Bachelor’s degree plus 4 years of manufacturing operations experience OR
• Associate degree plus 8 years of manufacturing operations experience OR
• High School Diploma/GED plus 10 years of manufacturing operations experience

Core Competencies & Skills

• Strong technical understanding of bioprocessing unit operations
• Hands‑on experience performing GMP manufacturing operations
• Knowledge of regulatory requirements and inspection readiness
• Ability to participate in and support cross‑functional teams
• Strong communication and collaboration skills across manufacturing, process development, and quality organizations
• Effective organizational, technical writing, and presentation skills
• Basic project management capabilities
• Foundational knowledge of process monitoring and control charting