Boston, MA, United States
Sciences, Scientist, Biotech
Area of Interest
About Fresenius Kabi
Fresenius Kabi is a global health care company that specializes in lifesaving medicines and medical technologies for infusion, transfusion and clinical nutrition. Our expansive portfolio of products and global network of science and manufacturing centers provide essential support for the care of critical and chronically ill patients. We are part of Fresenius SE, a health care group with more than 100 years of experience in pharmaceuticals, medical devices and life sciences. Our employees – more than 30,000 worldwide – develop and deliver injectable pharmaceuticals and infusion systems; blood collection, transfusion and cell technologies; and essential nutrients for parenteral nutrition.
Whether you work for us, buy from us, partner with us, or invest in us, you will come to know that caring is at the core of everything we do. Our purpose is to put lifesaving medicines and technologies in the hands of people who care for patients, and to find answers to the challenges they face every day.
Responsible for routine testing of in-process and finished product samples. Reviews and approves testing results of procedures performed in the department. Writes and revises standard operating procedures (SOP). Develops study protocols to validate production and laboratory methods. Assists with training of production and Quality Control personnel in microbiological methods.
Schedules, initiates, coordinates, performs routine testing of in-process, finished product, raw material, and environmental monitoring per SOP, as needed.
Generates standard test solutions as required.
Understands department priorities and importance of planning ahead.
Review work done by department staff for accuracy, completeness and conformance to specifications.
Keeps supervisory personnel informed of all relevant events impacting the operations and performance of the department including discrepancies and out of limit conditions.
Investigates nonconforming test results for product impact, root cause, and evaluates results to provide conclusions and appropriate corrective action.
Identifies additional testing to be performed to resolve these issues in a timely manner.
Investigates deviations from SOP requirements as directed by supervision for potential impact to product and materials and derives root cause of the incident.
Generates and updates new SOPs for microbiology test procedures. Updates and keeps others current.
Works with Lead/Senior Scientist, Supervisor or Manager in development and validation of new microbiological test methods.
Develops protocols for microbiology methods and production process validations. Participates in performing validation work. Performs studies needed to support incoming new products into the company.
Trains new department personnel in related SOPs. Assists in training manufacturing personnel in required aseptic technique and gowning technique as assigned by supervisor.
Maintains knowledge of cGMPs and GLPs. Ensures safety related polices are adhered and makes recommendations to enhance or improve safety policies.
Maintains knowledge of current compendial methods.
Coordinates special testing and project work as directed by management.
Maintains effective performance and constructive behavior during change.
Responsible for all aspects of maintenance of equipment and calibrations not performed by metrology or maintenance departments.
Performs other duties as assigned.
Bachelor of Science degree in a biological science with 3-5 years progressive laboratory experience. Equivalent combination of education and experience accepted.
Excellent verbal and written communication skills are essential.
Planning and organizational skills necessary for primary responsibilities.
Must successfully execute requirements to achieve ISO 5 environment gown certification as required by supervision.
We offer an excellent salary and benefits package including medical, dental and vision coverage, as well as life insurance, disability, and 401K with company match.
Fresenius Kabi is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disabilities, or protected veteran status.
Website : http://www.fenwalinc.com
Fenwal is a pioneer and global leader in the development of products that improve the safety and availability of blood. Our products help shape the practice of transfusion medicine, making life-saving blood therapies available to the medical professionals and patients worldwide who rely on them.