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:

　　Work in a dynamic production environment at site supporting development, clinical, and launch activities.

　　Work within the Cell Banking group and will perform operations for cell bank production.

　　Hands on operations in support of Cell Bank production in a clean room environment.

　　A bulk of the operations occur in a Grade 5 hood and requires additional gowning and strict adherence to aseptic practices.

　　Prepare media per defined manufacturing procedures (MPs) and standard operating procedures (SOPs)

　　Follow GMP documents (SOPs, MPs) with strict adherence to safety and compliance

　　Perform and monitor critical processes and able to interpret data to understand process performance

　　Perform in process sampling of cell culture flasks and operate analytical equipment

　　Maintain an organized and clean workspace

　　Work in a clean room environment wearing full clean room gowning, hairnet and latex gloves when performing all work.

　　Work performed in a Grade 5 hood requires additional gowning consisting on sterile mask, sleeves and double gloves

　　Initiate quality deviation records

　　Draft and revise documents (SOPs, MPs)

　　Identify, recommend, and implement improvements related to routine functions

　　Assist in the review of paper and electronic documentation for assigned functions (equipment logs, batch records)

　　Qualifications:

　　 Bachelor’s degree in Life Science or Biology

　　 3 years of Manufacturing & Operations experience

　　 Mechanically inclined

　　 Biotech Process Development or Manufacturing experience.

　　Cell Culture aseptic technique (entry level but experience is a plus via academia and work experience)

　　Day shift: Monday-Friday 8-5 business hours

　　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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