Quality Analyst

Quality Analyst Micro 3-6 Months Billerica, MA Max PR: $30.00 Perform testing on incoming materials, finished products and stability studies in QC Laboratory. Job Responsibilities Perform routine QC testing in accordance with SOPs and cGMP guidelines. Some supervision required. Perform verification of data to ensure accuracy. Perform approval upon discretion of supervisor. Assist with audit readiness of laboratory area and calibration and maintenance of laboratory equipment. Utilize a range of electronic systems such as LIMS and document/equipment management software. Author SOP changes; participate in change controls, CAPAs, other quality systems. Resolve routine problems by utilizing appropriate resources. Assist in investigations. May assist on special projects as needed. Help with continuous improvement. Train on and maintain knowledge of current regulatory requirements and relevant internal procedures. Team player who can work independently with quality and attention to detail. Good communication skills both oral and written, professional conduct. Effectively and efficiently participate in assigned tasks in a quality manner. Actively promote safety rules and awareness. Reports and takes initiative to correct safety & environmental hazards. Work with potentially hazardous chemical, radiological and/or biological materials on a daily basis. Demonstrate good safety practices at all times including the appropriate use of protective equipment. In case of absence the “Reports to” Manager above or a peer incumbent will function as a backup for this position. Education & Qualifications Typically requires 1-3 years of previous experience in the pharmaceutical industry, related GMP environment, or equivalent. Previous experience preferred. Requires a BA/BS degree in a related scientific discipline (e.g. chemistry, biology) or equivalent combination of education and experience. Familiar with aseptic technique Perform routine Environmental Monitoring and utilities testing Perform sterility, microbial limits and Endotoxin testing, identify and trend microorganisms Some non-routine travel may be required. Flexibility with scheduling requirements-may include shifts, overtime, weekends and holiday coverage, including during adverse weather conditions. Must be able to lift 50 lbs.