Job Description

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.

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.
  

Qualifications:

• Bachelor's degree in Life Sciences, Biology, Chemistry, and/or Engineering.
• 4+ years of manufacturing Operations experience.
• Detailed technical understanding of bioprocessing unit operations.
• 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
• Administrative Shift

Quality Consulting Group, LLC is an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, protected veteran status, disability status, or any other characteristic protected by law.