Senior Quality Assurance Microbiology Specialist I

Company: Rapid Micro Biosystems
Location: Framingham
Posted on: May 12, 2022

Job Description:

Winning the race to bring new healthcare products safely to-- -market-- -drives Rapid Micro Biosystems (RMB) to combine today's innovative technologies as never before. Your career at RMB puts you at the center of diverse global teams that span robotics, AI, Machine Learning, imaging, microbiology, and more, re-shaping how urgently needed pharmaceuticals are made, tested, and released for decades to come. The sky's the limit.-- --- -Careers at RMB are fast-moving, with the high growth you'd expect from a world leader in microbiology automation.-- -Advancement-- -at RMB-- -affords an-- -opportunity to achieve-- -your personal goals and-- -develop your-- -passions, in an inclusive environment where every employee has the resources and opportunities to hone their skills. You'll do more, learn more, and-- -can-- -make a-- -profound impact-- -on our business.-- --- -We are seeking a QC Microbiology Specialist for the Microbiology group based in Lowell.-- - The candidate will be responsible for conducting/coordinating analyses of raw materials and microbiology release testing of manufacturing production lots, in-process & finished products and formulations according to SOPs. Compiles data for documentation of test procedures and prepares reports. Ensures all testing processes, monitoring, and departmental documentation meet GMP standards. Assists in the development of new equipment, methodologies, concepts, techniques, and standards for Quality Control. Has complete understanding and application of principles, concepts, practices, and standards.The candidate must be well-versed with general microbiology laboratory techniques such as aseptic technique, culturing methodologies, microbial testing methods for bioburden and environmental monitoring, pipetting, autoclaving, and surface disinfection. Familiarity with word processing and data spreadsheet software, such as MS Office (particularly MS Word, MS PowerPoint and MS Excel) is required. Experience with Smartsheet, SAP, and Agile is strongly preferred. Experience working with Biosafety Level 2 organisms is required. Good writing and oral presentation skills are required. Must be well-organized, enthusiastic, dependable, hard-working and able to operate in a fast-paced environment. Experience in an ISO or GMP/GLP qualified lab environment and an understanding of statistical analysis a plus. Experience in experimental design desirable.Duties and Responsibilities: Perform microbiological and sterility testing on incoming and in-process inspection products Perform sterility testing for water samples Enumerate environmental monitoring samples & trend data Document all testing and results per cGMP standards. Initiate non-conformance and deviation reports in Agile, when necessary Perform investigations on adverse quality/performance conditions to understand root cause and corrective actions necessary for resolution Work in safe manner with strict adherence to all procedures. Perform experimental protocols as defined. Maintain documentation relevant to the quality system. Analyze data and write up results as appropriate in a timely manner. Maintain and develop Smartsheet project management tools & metrics tracking. Manage inventory dispositions following quality testing using SAP. Give oral and written presentations of work to co-workers and management. Maintain laboratory equipment and supplies as needed in collaboration with team. Work collaboratively and efficiently with internal scientific resources. Qualifications: B.S. in Microbiology or related field Senior thesis or other independent research experience Outstanding academic record 3-5 years of hands-on QC/QA lab experience Candidates with degrees in other life science fields will be considered if they have strong experience with microbial science research. Working Conditions: Work is mainly in a laboratory & office setting Some standing at work benches and fume hoods required ABOUT RAPID MICRO BIOSYSTEMS:Rapid Micro Biosystems creates, sells, validates, and services innovative products for fast, accurate, and efficient detection of microbial contamination in the manufacture of pharmaceuticals, biologics, biotechnology products, medical devices, and personal care products.The company's Growth Direct-- --- - --- -"-- - -the first and only growth-based system to automate rapid compendial QC Micro testing"-- - -ensures data integrity, compliance, and operational efficiencies driven by rapid methods and automation.Rapid Micro Biosystems is dedicated to providing groundbreaking technology and products to support companies in their journey to achieve greater reliability, efficiency, and better predictability, ultimately providing higher quality products for improved patient outcomes.Rapid Micro Biosystems is headquartered in Lexington, Massachusetts.-- - Our-- -research & development,-- -and manufacturing-- -operations are located in Lowell, Massachusetts. Additionally, we maintain field-- -offices in Freising, Germany; Switzerland, and Singapore.-- -Equal Opportunity:Rapid Micro Biosystems is committed to the principle of equal employment opportunity. Applicants for employment and employees are reviewed on their individual qualifications for a position. Under no circumstances will Rapid Micro Biosystems discriminate against qualified persons on the basis of race, color, religious creed, retaliation, national origin, ancestry, sexual orientation, gender identity, disability, mental illness, genetics, choice of health insurance, marital status, age, veteran status, or any other basis prohibited under applicable law.Please no phone calls or agencies, please.

Keywords: Rapid Micro Biosystems, Framingham , Senior Quality Assurance Microbiology Specialist I, Other , Framingham, Massachusetts