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:        

　　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 in Manufacturing facility.

　　Qualifications:

　　Master's Degree in life sciences or engineering

　　2 years of related 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

　　Strong project management skills, with prior project experience preferred.

　　Technical Writing skills

　　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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