QUALITY CONSULTING GROUP, a leader inthe 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:

• New Product Introductions (NPI) program management and non-capitol project management.
• Change control ownership, ensuring records are comprehensive and compliant per GMP regulatory procedures.
• Timely closure of change control records in relation to procedural guidance and/or disposition timelines
• Represent Manufacturing facility as the receiving site for incoming Technology Transfers/New Product Introductions
• Identifying improvement opportunities within the organization and take pro-active steps to build consensus to implement those opportunities.
• Presenting records and business processes to a variety of audiences, including auditors and inspectors
• Participating/leading Continuous Improvement Transformation activities
• Champion safety and compliance at all times
• Owning Change Controls to introduce new products to Clinical and Commercial Drug Product inManufacturing facility.

Qualifications:

• Master's Degreein life sciences or engineering
• 2 years of related experience
• Project Management experience
• Experience with PAS X Werum software for electronic batch records.
• Technical understanding of Drug Product (DP) manufacturing operations, such as buffer batching, DP formulation, DP Filling, Inspection
• Experience leading change controls in Trackwise
• Strong scientific, technical interactions with partner organizations such as Process Development, Process Engineering, Supply Chain, Quality Control, Regulatory
• Technical Writing skills