Job Description

Job Description

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 in a world-class manufacturing industry in Puerto Rico & USA.

Responsibilities:

• Support the manufacturing cleaning validation team through the execution of cleaning and sterilization validation activities.
• Write validation protocols and reports in support of cleaning and sterilization validation
• Ensure executed cleaning validation protocols are reviewed and closed out on time
• Prepare solutions required to support validation activities (e.g., riboflavin)
• Support manufacturing cleaning validation by ensuring protocol samples are collected and tested on time
• Draft and revise GMP manufacturing documents, including SOPs, FORMS, and protocols

Qualifications:

• Bachelor’s degree
• 2 years of work experience in related area
• Prior GMP knowledge, drug substance manufacturing, and validation exposure.
• Technical writing skills.
• Experience in GMP Technical Support roles, Validation, GMP operations, Engineering, or Process Development
• Technical knowledge of drug substance manufacturing and a broad understanding of related support areas
• Experience with project management or project support
• Equipment and cleaning validation experience preferred
• Data analysis and/or data visualization skill
• Fully onsite - 8am-5pm

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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