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 in 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.

• 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.

• Assist in generation of training materials and may assist in providing training on scientific or technical aspects of the process.

• Collect process-monitoring data and support the assessment of deviations.

• Provide support of timely execution of the process monitoring quarterly reports.

• Ensure that all Non-conformances are triaged within the established goal.

• Responsible for managing NC/CAPA closure within established goal.

• Review equipment/system Root Cause Analysis investigations and support trend evaluations.

• Assist with generation of process validation protocols and reports.

• Assist with the execution of the process validation.

• Participate in the NPI process to assess requirements for documentation, materials, training, and equipment modifications.

• Assess, prioritize, justify, and provide implementation and project management support for process or equipment modification projects.

• Assist manufacturing change owner on CCRB packages impacting the process.

Qualifications:

• Bachelor Degree in related area

• 5 years of Manufacturing Operations experience

• Experience managing facilities change control.

• Decommissioning processes experience.

• Experience using Trackwise and Veeva.

• 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 - 8:00 am to 5:00 pm (8hrs 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.

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