JT455 - SPECIALIST MANUFACTURING

Quality Consulting Group • Juncos, PR

2d

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 Life Sciences, Biology, Chemistry, and/or Engineering.
• 4+ years of manufacturing Operations experience.
• CAPA/ CAPA EV, Change Control knowledge
• Able to develop new procedures, enhance currents process, Implement new process, modify the current SOP’s.
• Provide training to operators.
• Skilled in performance of GMP production operations.
• Regulatory knowledge and interactions.
• Participate and help lead cross-functional teams.
• Ability to communicate and collaborate with technical and management staff within manufacturing, process development, and quality.
• Organizational, technical writing and presentation skills.
• Basic project management skills.
• Basic knowledge of control charting

Responsibilities

• Support the execution of manufacturing/quality systems such as non-conformances, process validation, procedures, training, and new product introductions.
• 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.
• Assist in the generation of training materials and may assist in providing training on scientific or technical aspects of the process.
• Ensures that processes, and procedures are aligned with cGMP requirements and/or other applicable regulations
• Responsible for ensuring that risks are identified, assessed, and corrected to ensure the safety, purity, quality, and efficiency of the product(s) manufactured
• Responsible for ensuring that the Electronic Batch Record is aligned with the current process and may assist in providing training.
• Assist with generation and the implementation of process validation protocols and reports.
• Participate in regulatory inspections
• Participate in the NPI process to assess requirements for documentation, materials, training, and equipment modifications.
• Assess, prioritize, support, and provide implementation and project management support for process or equipment modification projects.
• Own Change Control and ensure implementation within the established goal.
• Assist manufacturing change owner on CCRB packages impacting the process.
• Participate in noncommercial activity runs to support the collection and analysis of process data
• Participate on the assessment or implementation of special projects or initiatives.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level