What are the responsibilities and job description for the JT795 - MANUFACTURING SENIOR ASSOCIATE position at Quality Consulting Group, LLC?
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
