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Form of workJob Description
General Summary:
The Supervisor, Quality Control supervises operations of various functions in the QC department supporting validation, testing and reporting of raw materials, in-process, release and stability samples. This role is responsible for the supervision of other QC personnel, supporting the optimization of department resource allocation according to project/program needs to assure testing activities occur in an efficient and cGMP compliant manner while fostering the Vertex vision and values.
2nd Shift Hours: 1:30 PM - 10:00 PM
Key Duties and Responsibilities:
Knowledge and Skills:
Education and 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.
General Summary:
The Supervisor, Quality Control supervises operations of various functions in the QC department supporting validation, testing and reporting of raw materials, in-process, release and stability samples. This role is responsible for the supervision of other QC personnel, supporting the optimization of department resource allocation according to project/program needs to assure testing activities occur in an efficient and cGMP compliant manner while fostering the Vertex vision and values.
2nd Shift Hours: 1:30 PM - 10:00 PM
Key Duties and Responsibilities:
- Coordinate with the 1st Shift Supervisor, on laboratory activities to ensure prioritization and completion in a timely manner.
- Prioritizes resources appropriately to meet commitments on time.
- Ensure direct report lab personnel have adequate training, education, and experience to perform their GMP related job function effectively.
- Provides guidance to direct reports when issues arise
- Maintains and monitors related metrics to identify areas of focus
- Provides developmental feedback and coaching to direct reports to create a collaborative environment that attracts, develop and retains personnel
- Leads compliance related teams working towards the goal of continuous improvement.
- Authors and/or reviews data, SOPs, COAs, analytical methods, protocols and reports.
- May be required to lead OOS/OOT investigations/deviations and to identify corrective actions to prevent reoccurrence
Knowledge and Skills:
- Knowledge of US and EU cGMP regulations/guidance and some experience with regulatory agency inspections
- Strong knowledge of analytical methodologies such as chromatography, dissolution, and Karl Fisher and applying/interpretation of GMP requirements
- The ability to work in a fast-paced environment, manage priorities and maintain timelines for multiple projects is essential
- Strong attention to detail
- Effective communication skills, both verbal and written
Education and Experience:
- Bachelor's Degree in science or related discipline is required.
- Typically requires 6 years of experience in pharmaceutical/biopharmaceutical industry with less than 1 year of supervisory responsibility, or the equivalent combination of education and 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.
