Quality Assurance support and oversight of QC (Analytical and Microbiological) laboratory operations including laboratory investigations, deviations, corrective or preventative actions, method development, validation, and transfer activities, equipment validation work and associated projects. Quality Assurance support of QC associated with the manufacturing process including QC activity related to in process and release product testing, raw material testing, and environmental monitoring activities. Assesses QC driven change controls and supports completion of any associated change actions. Participates in ongoing laboratory operations/continuous improvement and risk management projects. Participates in risk assessments related to QC laboratory operations. Identifies and reports discrepancies from required work practices or procedures to management. Makes sound decisions by exercising judgment within generally defined practices and policies and applies appropriate notification to management as appropriate. Participates as requested in the response team for audits and inspections by health authorities. Conducts regular walkthroughs of QC laboratories. Performs review and approval of Quality, Laboratory, and Analytical Standard Operating Procedures (SOPs) and documents. Provides oversight to identify and implement changes that lead to realization of long-term department and company goals. Work-life programs include paid national holidays and optional holidays, Global Shutdown Days between Christmas and New Year's holiday, up to 120 hours of paid vacation, up to two (2) paid days to volunteer, sick time off, and summer hours flexibility. Bachelor's degree in engineering or a life or physical science related field (including biology, biochemistry, chemistry) is required. Minimum 10+ years relevant work experience (analytical development, Quality Control, and/or Quality Assurance), preferably in a regulated environment is required. An equivalent combination of education and experience may substitute. Knowledge of analytical method lifecycle including development, validation, and transfer Practical understanding of common QC procedures, techniques, and laboratory equipment/instrumentation and the application and interpretation of most-relevant GMP concepts and compendia requirements (e.g. US FDA, CFR, USP, EP, JP) Knowledge of Microbiological assay methodologies such as sterility, bioburden, container closure, and endotoxin. Knowledge of common QC and environmental monitoring procedures and techniques. Strong background and demonstrated effectiveness in quality assurance operation and compliance of Clinical and commercial Quality laboratory operations. Strong background and demonstrated effectiveness in quality assurance operation and compliance of clinical/commercial manufacturing is desired. Knowledge of US, EU and rest-of-world cGMP regulations and guidance. Knowledge and proven experience in FDA, EMA, or other regulatory authority. Excellent writing and oral communication skills are required. Previous work responsibility, which required a high degree of attention to detail. Well-practiced in exercising sound judgment in decision-making. Physical Demands While performing the duties of this job, the employee is regularly required to sit, reach with hands and arms, and talk or hear. The employee must occasionally lift and/or move up to 30 pounds. Specific vision abilities required by this job include close vision and distance vision. This is a position that requires working in a laboratory environment, protective clothing, gloves, and safety glasses are required while working in a laboratory environment with radioactive materials. The starting compensation for this job is a range from $124,449 - $150,800, plus incentive cash and stock opportunities (based on eligibility). The starting pay rate takes into account characteristics of the job, such as required skills and where the job is performed. Final, individual compensation will be decided based on demonstrated experience. Eligibility for specific benefits listed on our careers site may vary based on the job and location.