Manufacturing Specialist - Regulated Industry

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

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.

• 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

• 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 Track Wise, 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

• 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 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

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

• 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…