Quality Assurance Associate II
• Review and approve executed batch records for material release
• Independently perform monitoring of the manufacturing activities to ensure GMP compliant processes are being followed in the manufacturing suites.
• Perform line clearances prior to manufacturing and packaging operations
• Review in-process testing data for compliance as being performed (HPLC, pH, balance weights)
• Create labels for stability, testing and final product packaging
• Review of manufacturing deviations and change controls
• Ensure equipment being utilized has been calibrated and is ready for use and maintained throughout the process
• Ensure materials being used are within expiry
• Ensure operators are wearing appropriate PPE for safety and to prevent product contamination
• Escalate objectionable cGMP practices to management
• Maintain QA manufacturing KPIs as required
• Perform any needed follow-up activities including investigations and audits on an as-needed basis
• Other duties as required
• BS/BA in Chemistry or life sciences preferred and Minimum of 2 years’ experience working in the Pharmaceutical, Biotech, or related industry.
• Strong knowledge of USP, CFR 21 and ICH guidelines in regard to GMP.
• Ability to use scientific principles/process/regulatory knowledge to identify compliance issues
• Is thorough when performing work; conscientious about attending to detail; uses logical thinking that is well organized and methodical
• Able to multi-task productively, applying time management processes and procedures effectively
• Technically capable of determining what is wrong in complex situations and offering potential solutions, identifying root cause of a problem and working with others to correct problems
• Effective verbal and written communication skills
• Computer skills in MS Word, EXCEL, Empower 3 and Access are desirable
• Must be able to sit or stand for long periods of time.
• Must be able to squat, lift, push or pull at least 50lbs.
• Must be able to wear safety shoes & glasses through-out the day while in designated areas. (provided by the company)
• You must be cleared by a physician to wear a respirator throughout the day while in designated areas.
• Must be ok working in a chemical environment.