Job Description
General Summary:
The EM/UM Quality Control Specialist provides testing support for the QC environmental monitoring and utilities monitoring (EM/UM) laboratory supporting oral dose and cell therapy GMP manufacturing facilities. Specific assigned persons are responsible for hands-on media fills (Aseptic process qualification samples), environmental monitoring and utilities sampling and testing while ensuring activities occur in an efficient and cGMP compliant manner fostering the Vertex vision
Key Duties and Responsibilities:
- Collect, transport and process media and environmental monitoring of air, surface, personnel gowning, water, gas and steam systems samples according to established schedules or as requested with minimal supervision.
- Perform microbiological (Bioburden, sterility, growth promotion) and chemical assays (Endotoxin, Total Organic Carbon, Conductivity, and Nitrates), related to clean room monitoring, utility monitoring independently following established methodology, procedures and SOPs.
- Analyze organisms on cultured media (solid and liquid) from aseptic processing qualifications (media fills), environmental monitoring and utility samples
- Maintain accurate sampling and testing records and adhere to cGMP/GDP expectations
- Participate in executing method validations, aseptic personnel/process, and/or classified areas qualifications.
- Troubleshoot microbiological and chemical methods with the assistance of supervisor when necessary
- May be required to author and review data, procedures, microbiological and chemical methods, protocols, reports, deviations, and other quality records.
- Participates in compliance related teams working towards the goal of continuous improvement.
- Provide environmental monitoring and utilities monitoring guidance for training to junior staff or other departments.
- Perform maintenance of instrument/ equipment calibration, temperature monitoring, reagent preparation, material and supply ordering and other general lab related responsibilities, as needed.
- Assists in everyday organization of the EM/UM laboratory including safety, cleaning, maintenance and ordering of supplies.
- Perform other laboratory duties as assigned
Knowledge and Skills:
- Knowledge of US and EU cGMP regulations/guidance and some experience with regulatory agency inspections.
- Strong knowledge of pharmaceutical microbiology methods and/or sterile techniques and applying/interpretation of GMP requirements. Expertise with bioburden testing, sterility, endotoxin content testing, plate enumeration, growth promotion, etc. on a variety of sample types, related to media fills, environmental and clean utilities monitoring
- The ability to work well on a team in a fast-paced environment, manage priorities and maintain timelines for multiple projects
- Strong attention to detail, proactive, action oriented and can rapidly adapt to a change
- Effective communication skills, both verbal and written, at all levels and across various functions.
- Have hands on experience using and improving Laboratory Information Management System (LIMS) and Electronic Laboratory Notebooks (ELN)
- Ability to work weekends and off-shift hours, as needed.
Education and Experience:
- Bachelor's Degree in science or related discipline
- 1+ years of experience in GMP pharmaceutical/biopharmaceutical industry, or the equivalent combination of education and experience, with at least 1 year of laboratory experience
Company Information
Vertex is a global biotechnology company that invests in scientific innovation.
Vertex is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, sex, gender identity or expression, age, religion, national origin, ancestry, ethnicity, disability, veteran status, genetic information, sexual orientation, marital status, or any characteristic protected under applicable law. Vertex is an E-Verify Employer in the United States. Vertex will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.
Please note that Vertex requires COVID-19 vaccination for all employees working in the U.S. as a condition of employment at Vertex, subject to medical, religious or other accommodations or exemptions required by law. We believe this requirement is vital to keeping everyone at Vertex and in our communities safe. This requirement applies to both existing and new employees who may at any time work on-site at a Vertex facility or visit another location on behalf of Vertex (e.g., conferences, customer visits, etc.), including all remote employees. Any applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should make a request to the recruiter or hiring manager, or contact Talent Acquisition at ApplicationAssistance@vrtx.com.
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