Marlborough, Westborough, Boston, Hartford, Nashua, Providence
Connecticut, Massachusetts, New Hampshire, Rhode Island
Provide critical microbiology expertise as it relates to bioprocessing within our CDMO business located within our Fast Trak group in Marlborough, MA. Focus includes performing routine microbiological assays and testing i.e. environmental monitoring, water sampling, compressed air/gas systems monitoring, bioburden and endotoxin testing. Collaborate with internal partners and stakeholders (QA, Validation, Calibration, Raw Materials, and MFG), and external contractors, suppliers and clients.
· Perform TOC, conductivity, nitrates, endotoxin, bioburden, and other microbiological testing
· Perform environmental, personnel, and utilities monitoring
· Perform raw material, in-process, final release, and non-routine testing to support drug products.
· Maintain excellent aseptic technique
· Perform document review and management, maintenance (routine and preventive operation) of equipment, and supporting routine laboratory operations (cleaning the laboratory, inventory control, etc).
· Document activities with strong adherence to GMP and GDP quality systems
· Maintain product quality for all manufactured drug products
· Generate and revise SOPs, investigations, trend reports and other documentation as needed
· Provide microbiological input into excursion investigations
· Participate extensively in high-level quality systems programs (Deviations, CAPA, etc.)
· Participate, contribute, and add value in cross-functional collaborations
· Collaborate and communicate appropriately within the QC group, cross-functionally, and with external customers
· Understand priorities, independently plan to execute projects, and involve others as needed
· Bachelor’s degree in either; Biology, Microbiology or related field.
· 2 - 5 years’ experience working in Quality Control for the biopharmaceutical industry
· Awareness of GMP and governmental regulations related to drug manufacturing, sufficient to appreciate the need for documentation accuracy.
· Ability to read and interpret professional journals and technical procedures, write test protocols and reports; communicate test analysis and results.
· Outstanding communication and inter-personal skills
· Proficient with Microsoft tools; Word, Excel, and Power Point
· Excellent communication, relationship building, and influencing skills with ability to gain buy-in for initiatives.
· Hands-on experience with environmental monitoring, water sampling, and compressed gas/air systems.
· Ability to work in and for cross-functional teams such as supporting development, global manufacturing and marketing teams.
· Experience in leading projects/activities to meet customer requirements.
· Experience working in an Agile work environment.
GE Healthcare Life Sciences www.corporate.gehealthcare.com There is no other life sciences company quite like GE Healthcare Life Sciences. A $5 billion business with more than 11,000 individuals in over 100 countries, we are at work enabling a new era in medicine. For more than 60 years, GE Healthcare Life Sciences has globally supported the development and use of new therapies, helping accelerate the journey from biological understanding to clinical therapy. GE Healthcare Life Sciences works with cutting edge technology enabling and advancing the discovery, diagnosis and medical treatments of the present and the future. We are accelerating biology to cell therapy in ways no other company can. Follow us on Facebook and Twitter and watch our discoveries in action on our YouTube channel.
GE offers a great work environment, professional development, challenging careers, and competitive compensation. GE is anEqual Opportunity Employer . Employment decisions are made without regard to race, color, religion, national or ethnic origin, gender (including pregnancy), sexual orientation, gender identity or expression, age, disability, veteran status or any other characteristics protected by law.
Additional Eligibility Qualifications
GE will only employ those who are legally authorized to work in the United States for this opening. Any offer of employment is conditioned upon the successful completion of a drug screen (as applicable).