Associate, Quality-Batch Release/Ops

Company: Disability Solutions
Location: Princeton
Posted on: September 14, 2023

Job Description:

At Dr. Reddy's "Good Health Can't Wait" By joining Dr. Reddy's, you will contribute to making the breakthroughs of tomorrow a reality today! From making medicines more affordable to discovering innovative treatment options to satisfy unmet medical needs, we are dedicated to helping people lead longer and healthier lives. We are seeking dynamic and energetic individuals ready to inspire, ready to make a difference for their community and every community.Diversity, Equity & Inclusion At Dr. Reddy's, we are deeply committed to building a diverse, equitable and inclusive workplace where everyone belongs and is valued for their contributions to the team. We are most interested in finding the best candidate for the role and are open to exploring candidates with a less traditional background. Purpose: We have an opening for an Associate, Quality-Batch Release/Ops in our Princeton, NJ office. Responsibilities:

• Batch record review and batch release of products from CMOs to the US This involves the critical independent review of Quality Control, manufacturing, packaging and Quality Assurance records.
• QA oversight of contract manufacturing and packaging activities at External Manufacturing Partners (Contract Manufacturing Organizations - CMOs), which manufacture, package or supply for distribution of Rx and SRx (drug and drug device combination products), OTC products and dietary supplements by Reddy's North America business.
• Responsible for QA oversight of 3PL distribution centers
• Timely review and release of products from DRL Princeton CMOs and suggesting continuous improvements of systems at external partners (CMO's and contract packaging organization, CPO's) to assure compliance to CGMP's and FDA expectations.
• QA oversight of Quality Management Systems (deviation investigation, CAPA, and minor Change Control).
• Support and interface with customer service teams to provide the customer requests for COA's and other documentation
• Manage Quality secondary reconciliation updates in the DEA controlled substances import management system Qualifications/Skills:
  • BA/BS (preferably in Science) or High school diploma with equivalent work experience.
  • Minimum 2 years of experience working in cGMP manufacturing.
  • Previous Quality Assurance experience is preferred. Must be a U.S. citizen or lawful permanent resident of U.S. or otherwise authorized to work in the U.S. without requiring sponsorship now or in the future.COVID-19 VaccinationGetting vaccinated remains the most effective way to halt the spread of the COVID-19 pandemic, and Dr. Reddy's encourages all employees to be vaccinated. At this time, vaccinations are not mandated for Princeton-based employees but may become required in the future. Weekly COVID testing is mandatory for all employees who have not uploaded proof of vaccination or who are not fully vaccinated. Equal Opportunity Employer: An Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability.

Keywords: Disability Solutions, Trenton , Associate, Quality-Batch Release/Ops, Other , Princeton, New Jersey