What are the responsibilities and job description for the QC Analyst I, Microbiology position at Landmark Bio?
Landmark Bio translates groundbreaking research into life-changing medicines. We provide development, manufacturing, and regulatory capabilities to help early-stage life science innovators rapidly progress advanced therapies from bench to clinic. Launched in 2021, and based in Watertown, Mass. Landmark Bio is an unprecedented venture bringing together the best of industry, academia and research hospitals to accelerate life sciences innovation. A public benefit company, our work advances emerging technologies, demonstrates therapeutic potential, and improves human health.
We are seeking a highly motivated and team-oriented professional with entrepreneurial spirit to join our company! This is an exciting opportunity for a well-qualified candidate to join a rapidly growing company focused on turning today’s cutting-edge research into tomorrow’s breakthrough therapies.
We are seeking a QC Analyst I, Microbiology, who will report to the Manager of QC Microbiology. The scope of responsibilities includes, but is not limited to, the following:
•Perform routine Microbiology testing, including for example, environmental monitoring, bioburden, endotoxin, sterility, growth promotion, APS, APQ, and utility monitoring, following Landmark Bio standard operating procedures and test methods.
•Maintain laboratory equipment and instruments in good working condition, following appropriate procedures for usage, clean-up, and maintenance.
•Maintain and follow all laboratory system, cGMP, safety, and housekeeping requirements.
•Participate in the execution of method qualifications for sterility, bioburden and endotoxin.
•Support execution of EMPQ, EM sample site selection, risk assessments, and utility system qualifications.
•Initiate and own quality events, including deviations, CAPAs, and change controls.
•Author and approve documentation, including test methods and standard operating procedures.
•Document all testing performed according to applicable cGMP, Good Documentation Practices, and GLP.
•Coordinate and work with external contract testing laboratories and internal cross-functional teams.
•Handle lab waste and transfer to a central point as defined by procedures.
•Maintain testing materials and supply inventory needs for QC Microbiology laboratory.
•Assist in investigations, non-conformances, and deviations in areas of assigned responsibility.
•Occasional late hours and weekend work may be required.
•Additional job responsibilities as agreed with the Manager.
Qualifications
•Minimum BSc degree in Microbiology, Biology, or STEM equivalent.
•Minimum 1 years’ experience QC lab work in GMP cleanroom and QC Microbiology laboratory; experience performing sterility, endotoxin, and environmental monitoring preferred.
•Experience working with rapid sterility (BacT) and Endotoxin (MCS) systems preferred.
•Working knowledge of USP test methods in microbiology lab preferred.
•Excellent verbal and written communication skills.
•Multi-tasking, attention-to-detail, and record-keeping skills.
•High level of ownership, accountability, and critical thinking skills; able to demonstrate a sense of urgency and to work cooperatively in a team setting.
Landmark Bio is an Equal Opportunity, Affirmative Action employer. Minorities, women, veterans, and individuals with disabilities are encouraged to apply.
