Project Manager Jobs in Massachusetts

Job Title: Project Manager - Quality Assurance, Fill/Finish Company: Kaztronix, LLC Location: Allston, MA Description: Project - Quality Assurance, Fill/Finish Job Description: The Project is responsible for providing leadership and guidance to the Quality Assurance group supporting aseptic filling, labeling, and packaging operations. This individual will report to the Director of Quality Assurance Operations. Major responsibilities include: Develop, improve, and monitor quality systems to ensure Quality Assurance consistently operates in compliance with procedures Oversee training, ensuring QA staff are ready to perform each assigned operation Oversee record review and batch disposition processes for bulk vials and labeled/packaged product Facilitate timely issue resolution to support sound product disposition decisions Oversee maintenance of specifications for finished product and labeling/packaging components, in partnership with all other stakeholders Collaborate with key stake holders during planning and process improvement activities to ensure timely completion of operational areas objectives and milestones consistent with site priorities and objectives Approve validation plans and protocols Provides coaching and guidance to QA staff Skills: Required Qualifications: A minimum 10 years experience in a pharmaceutical/biotech GMP manufacturing environment Demonstrated leadership in an operational/GMP plant setting Must be well organized, detail-oriented, and able to work with minimal supervision A working knowledge of statistical analysis, process, software and method validation Excellent verbal and written communication skills Knowledge of relevant FDA and EMEA regulations Education: 4 year degree, or equivalent. BS in Science, Engineering is preferred. Degrees Required: BA/BSPlease refer to job code 10-01653 when responding to this ad.