- Responsible to execute the overall environmental monitoring programs and related microbiology testing to support the internal manufacturing facility
- Responsible to lead the microbiology related testing that occurs with both Vor's EM program as well as product support (internal and external microbiology and viral related testing)
- Execute day to day EM/Micro operations as assigned to support the manufacturing in the GMP manufacturing facilities
- Ensure adherence to cGMP practices for QC Microbiology laboratory operations and testing
- Support / lead continuous improvement initiatives related to EM topics
- Support the timely generation of the periodic reports for cleanroom environment, utilities, and microbial isolates
- Lead investigations for EM excursions, microbial investigations, and out of specification results and recommend/assist in implementing appropriate corrective actions
- Ensure that training is current for assigned responsibilities
- Work safely within designated spaces, and responding to safety inspections and audits as required / requested
- BSc, MSc, PhD or equivalent life sciences degree with a minimum of 8 years pharmaceutical industry experience including 2+ years in Quality Control EM/Micro related role(s)
- Experience with cell and gene therapy products preferred
- Experience in regulatory inspections, including dealing with compliance issues identified by regulatory authorities preferred
- Experienced, self-motivated individual who can handle multiple priorities to meet project team goals and timelines
- Excellent written and verbal skills and the ability to communicate clearly, concisely, and effectively
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Analyst II/Senior Analyst, Quality Control, Environmental Monitoring - Cambridge, United States - Vor Biopharma Inc.
Description
Who we are looking for:
Vor Bio is seeking an experienced Quality Control Analyst II/Senior Analytst to be a part of the team responsible for the day-to-day operations assigned to the QC Microbiology group, including sampling of a cGMP manufacturing facility, testing samples in the QC Microbiology laboratory for batch release of advanced therapeutics including cellular and gene therapy products.
The role is also responsible for the execution of environmental and utilities monitoring program of multiple cleanroom suites, including collecting and testing samples, and coordinating ID activities with external vendors, and investigating atypical results, and supporting trend analysis.
The successful candidate will support and potentially lead continuous improvement initiatives within the group and with cross functional teams.The candidate will work collaboratively with department management to ensure successful execution of the EM program at Vor Bio's internal manufacturing facility.
This individual may be asked to support external provider investigations where required.Key areas of responsibility:
Qualifications:
