Vertex Pharmaceuticals Incorporated
Quality Control Senior Specialist
Vertex Pharmaceuticals Incorporated, Boston, Massachusetts, us, 02298
Job Description
Employer:
Vertex Pharmaceuticals Incorporated
Job Title Quality Control Senior Specialist
Location 1 Harbor Street, Boston, Massachusetts, 02210
Openings 1
Duties
Provide a variety of analytical functions that occur in the QC department supporting validation, testing and reporting of in‑process, release and stability samples.
Ensure activities occur efficiently and cGMP compliant while fostering the Vertex vision and values.
Serve as RSL representative in cross‑functional and cross‑departmental working teams and with outside vendors to meet all laboratory needs.
Coordinate and facilitate laboratory activities to meet commitments on‑time.
Maintain accurate laboratory records and adhere to cGMP/GDP expectations.
Participate in planning, executing and/or review of method validations, method transfers and equipment qualification/requalification.
Assist in troubleshooting analytical methods and/or equipment as required.
Author, review, and approve data, SOPs, COAs, analytical methods, protocols, and reports.
Lead compliance‑related teams working toward continuous improvement.
Perform in‑process, release and stability testing and/or review independently following established methodology, procedures and SOPs.
Lead OOS/OOT investigations/deviations and identify corrective actions to prevent reoccurrence.
Requirements Employer will accept a Bachelor's degree or foreign equivalent in health science, pharmaceutical sciences, or a related field and at least 5 years of experience in the job offered or in a Quality Control Senior Specialist‑related occupation.
Position requires demonstrable experience in the following:
Knowledge of U.S. and EU cGMP regulations, guidance, and experience with regulatory agency inspections.
In‑process, release, and stability testing and review independently following established methodology, procedures, and SOPs.
Participation in analytical method validation protocol discussions and leading planning and execution of method validations and method transfers.
Ensuring accurate laboratory records and adherence to cGMP/GDP expectations.
Troubleshooting analytical methods and analytical equipment as required.
Investigating OOT/OOS results and other deviations.
Key Analytical Methodologies
HPLC with Empower software
Dissolution
FTIR spectrophotometry
UV‑VIS spectrophotometer
Pay Range $94,300.00 – $141,400.00 per annum
Work Designation On‑site designated. You will work five days per week on‑site with ad hoc flexibility. Flex status is subject to Vertex's Flex policy and may change at any time.
Contact Send resume to futuretalent@vrtx.com. Reference 12140.644. EOE.
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, regardless of 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 and will make reasonable accommodations for qualified individuals with known disabilities in accordance with applicable law.
Applicants requiring an accommodation should contact ApplicationAssistance@vrtx.com.
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Vertex Pharmaceuticals Incorporated
Job Title Quality Control Senior Specialist
Location 1 Harbor Street, Boston, Massachusetts, 02210
Openings 1
Duties
Provide a variety of analytical functions that occur in the QC department supporting validation, testing and reporting of in‑process, release and stability samples.
Ensure activities occur efficiently and cGMP compliant while fostering the Vertex vision and values.
Serve as RSL representative in cross‑functional and cross‑departmental working teams and with outside vendors to meet all laboratory needs.
Coordinate and facilitate laboratory activities to meet commitments on‑time.
Maintain accurate laboratory records and adhere to cGMP/GDP expectations.
Participate in planning, executing and/or review of method validations, method transfers and equipment qualification/requalification.
Assist in troubleshooting analytical methods and/or equipment as required.
Author, review, and approve data, SOPs, COAs, analytical methods, protocols, and reports.
Lead compliance‑related teams working toward continuous improvement.
Perform in‑process, release and stability testing and/or review independently following established methodology, procedures and SOPs.
Lead OOS/OOT investigations/deviations and identify corrective actions to prevent reoccurrence.
Requirements Employer will accept a Bachelor's degree or foreign equivalent in health science, pharmaceutical sciences, or a related field and at least 5 years of experience in the job offered or in a Quality Control Senior Specialist‑related occupation.
Position requires demonstrable experience in the following:
Knowledge of U.S. and EU cGMP regulations, guidance, and experience with regulatory agency inspections.
In‑process, release, and stability testing and review independently following established methodology, procedures, and SOPs.
Participation in analytical method validation protocol discussions and leading planning and execution of method validations and method transfers.
Ensuring accurate laboratory records and adherence to cGMP/GDP expectations.
Troubleshooting analytical methods and analytical equipment as required.
Investigating OOT/OOS results and other deviations.
Key Analytical Methodologies
HPLC with Empower software
Dissolution
FTIR spectrophotometry
UV‑VIS spectrophotometer
Pay Range $94,300.00 – $141,400.00 per annum
Work Designation On‑site designated. You will work five days per week on‑site with ad hoc flexibility. Flex status is subject to Vertex's Flex policy and may change at any time.
Contact Send resume to futuretalent@vrtx.com. Reference 12140.644. EOE.
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, regardless of 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 and will make reasonable accommodations for qualified individuals with known disabilities in accordance with applicable law.
Applicants requiring an accommodation should contact ApplicationAssistance@vrtx.com.
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