JT969 - SPECIALIST MANUFACTURING

Quality Consulting Group•Juncos, PR

About The Position

QUALITY CONSULTING GROUP, a leader in the pharmaceutical, biotech, medical devices, and manufacturing industry, is looking for a talented, highly motivated and enthusiastic to join our team. In this role, you’ll work with a highly enthusiastic team, contributing to a world-class manufacturing industry in Puerto Rico & USA.

Requirements

Bachelor's degree in science or industrial engineering preferred
4 years of Manufacturing Operations experience
Experience in CAPA and Change Orders in Manufacturing environment
Skilled in performance of GMP production operations
Regulatory knowledge and interactions.
Experience in manufacturing, process development in Biotech or pharmaceutical industry.
Experience managing quality records (deviations, CAPAs, CAPA-EV, Change Controls, Supplier Investigation Records) using TrackWise, or Vevaa or a comparable quality system
Experience navigating and executing transaction in SAP (ERP) system.
Proficient with Microsoft Office Tools (Word; Excel; PowerPoint; Project, Teams, Outlook)
Available for administrative shift

Responsibilities

Support the execution of manufacturing such as non-conformances, process validation, procedures, training, and new product introductions.
Apply process, operational, scientific expertise, basic compliance knowledge, and analytical and troubleshooting skills to support manufacturing operations.
May serve as primary production process owner for process support systems and assist with process ownership responsibilities on more complex process systems.
Initiate, revise, and approve manufacturing procedures.
Ensure all procedures reflect current operations.
Serve as a document owner.
Assess process performance by observation of floor operations and review of performance data.
Evaluate, plan, and implement solutions for process improvement opportunities.
Provide troubleshooting support.
Provide support of timely execution of the process monitoring quarterly reports, Non-Conformance and CAPA.
Ensure that all Non-conformances are triaged within the established goal.
Responsible for authoring investigation reports.
Responsible for execution of corrective actions.
Responsible for managing NC/CAPA closure within established goal.
Monitor and communicate incidents trends.
Review equipment/system Root Cause Analysis investigations and support trend evaluations.
Assist with generation of process validation protocols and reports.
Participate in the NPI process to assess requirements for documentation, materials, training, and equipment modifications.
Assist manufacturing change owner on CCRB packages impacting the process.
Participate on the assessment or implementation of special projects or initiatives.