Synectics
Description : Maintain shop floor quality presence, dispose of in-process materials and finished products, investigate and resolve GDP errors, and perform batch record reviews. Ensure the quality of manufactured products complies with all applicable regulations and guidelines. Assist in preparing for regulatory and customer audits. Review and approve general and complex manufacturing formulation batch production records in support of product release, in accordance with specifications and SOPs. Inspect and release intermediates or packaged drug products per specifications. Monitor various stages of processing along with the appropriate paperwork to ensure compliance with specifications. Draft and review specifications and SOPs. Monitor and analyze batch record errors and provide quality indicator data to QA management. Provide guidance to less experienced staff as needed. Support sitewide daily walkthroughs of GMP areas. Qualifications : B.S. in Biology, Chemistry, or a related discipline, or equivalent experience is preferred. Experience in documentation review. Experience working in a GMP environment. Open to candidates with a biology or similar degree seeking GMP experience. At least 2 years of relevant experience in a regulated environment, with a focus on product quality. Knowledge of biotech product manufacturing. Knowledge of US and EU cGMP regulations and guidance. Knowledge of Oracle, BMRAM, MES, Veeva Infinity is a plus. Benefits : Healthcare Insurance: Coverage through BlueCross BlueShield of Illinois, eligible from the 1st day of the month following 60 days of employment, with premiums subsidized. Dental Insurance: Coverage through MetLife, eligible from the 1st day of the month following 60 days of employment. Vision Insurance: Coverage through VSP, eligible from the 1st day of the month following 60 days of employment. 401(k) Plan: Investment savings plan available to employees aged 21 and over, with enrollment on Jan 1, Apr 1, Jul 1, and Oct 1. Technical Certification Bonus: Up to $500 for approved professional certifications, awarded 90 days after documentation receipt. Synectics is an equal opportunity employer. #J-18808-Ljbffr