QA Associate

Join Our Team as a QA Associate! As a QA Associate, you will be essential in maintaining product quality and compliance. This role involves batch record reviews, process monitoring, and providing GMP area support. Ideal for recent graduates with a scientific degree, this position offers valuable GMP experience... Responsibilities • Maintain a quality presence on the shop floor, managing the disposition of in-process and finished products • Investigate and resolve Good Documentation Practice (GDP) errors • Perform and approve batch record reviews to support product release, ensuring adherence to specifications and SOPs • Inspect and release intermediates and packaged drug products according to specifications • Oversee various stages of processing to ensure compliance with established specifications • Draft and review specifications and Standard Operating Procedures (SOPs) • Track and trend batch record errors, providing data insights to QA management • Mentor and provide guidance to junior staff members • Conduct daily walkthroughs in GMP areas, offering sitewide support Key Skills • Proficiency in documentation review • Strong understanding of Good Manufacturing Practices (GMP) • Knowledge of biotech product manufacturing processes • Familiarity with US and EU cGMP regulations and guidance • Experience with Oracle, BMRAM, MES, and Veeva Infinity is advantageous Experience • Minimum of 2 years of relevant experience in a regulated environment • At least 2 years focused on product quality • Experience in a GMP environment • Proven documentation review experience Education • Bachelor’s degree in Biology, Chemistry, or a related discipline is preferred If you are a detail-oriented professional with a passion for quality assurance, apply now and join our team! About SSi People With over 25 years of industry experience, SSi People has built its reputation and expertise on putting people first. Everything we do works toward delivering an exceptional experience for our consultants, our clients, and our internal team. Through a genuine commitment to people in everything we do. We have developed refined processes and a stellar internal team to deliver talent quickly. More importantly, we focus on building long-term relationships, not transactions. Putting people first is just what we do well