GxP Operations Support Specialist Data Review
Vertex Pharmaceuticals
Summary
The GxP Operations Support Specialist role provides a variety of analytical functions that occur in the Quality Control (QC) department supporting validation, testing and reporting of in-process, release and stability samples. This role also helps ensure activities occur in an efficient and cGMP compliant manner while fostering the Vertex vision and values.
Job description
General Summary
The GxP Operations Support Specialist role provides a variety of analytical functions that occur in the Quality Control (QC) department supporting validation, testing and reporting of in-process, release and stability samples. This role also helps ensure activities occur in an efficient and cGMP compliant manner while fostering the Vertex vision and values.
Key Duties and Responsibilities
- Perform in-process, release, and stability testing and/or review independently following established methodology, procedures and SOPs
- Maintain accurate testing records and adhere to cGMP/GDP expectations
- May participate in executing method validations and/or method transfers
- Assist in troubleshooting of analytical methods with the assistance of manager when necessary
- May participate in author and review of data, SOPs, analytical methods, protocols and reports
- May participate in compliance related teams working towards the goal of continuous improvement
- Report OOT/OOS results and other deviations to area management
- Perform other laboratory duties as assigned
Knowledge and Skills
- Understands cGMP concepts and general practices
- Knowledge and experience in chromatography, dissolution, and Karl Fisher
- Knowledge of various complex laboratory equipment including HPLC, GC, KF, dissolution, TOC, UV, IR, pH meter, and balance
- Strong attention to detail
- Demonstrate good communication skills both oral and written
Education and Experience
- Bachelor Degree in science or related discipline is required
- 1 year of experience in GMP pharmaceutical/biopharmaceutical industry
Requirements
- Bachelor Degree in science or related discipline is required
- 1 year of experience in GMP pharmaceutical/biopharmaceutical industry
- Understands cGMP concepts and general practices
- Knowledge and experience in chromatography, dissolution, and Karl Fisher
- Knowledge of various complex laboratory equipment including HPLC, GC, KF, dissolution, TOC, UV, IR, pH meter, and balance
- Strong attention to detail
- Demonstrate good communication skills both oral and written
Benefits
- Annual Bonus
- Annual Equity Awards
- Overtime Pay Eligibility
- Medical Insurance
- Dental Insurance
- Vision Insurance
- Paid Time Off
- Summer Company Shutdown
- Winter Company Shutdown
- Educational Assistance
- Student Loan Repayment
- Commuting Subsidy
- Matching Charitable Donations
- 401(k)
Company overview
Vertex Pharmaceuticals is a global biotechnology company headquartered in Boston, Massachusetts, founded in 1989. The company specializes in discovering, developing, and commercializing transformative medicines for serious diseases, with a primary focus on cystic fibrosis (CF). Vertex has pioneered breakthrough therapies including TRIKAFTA/KAFTRIO, SYMDEKO/SYMKEVI, ORKAMBI, and KALYDECO, which collectively treat approximately 90% of CF patients. Beyond CF, the company has expanded its portfolio to include treatments for sickle cell disease, transfusion-dependent beta thalassemia, acute pain, and has robust clinical pipelines in APOL1-mediated kidney disease, type 1 diabetes, myotonic dystrophy type 1, and alpha-1 antitrypsin deficiency. Vertex employs approximately 6,100 people globally and maintains research facilities in San Diego, California, and Milton Park, Oxfordshire, England. The company is publicly traded on NASDAQ (VRTX) and is recognized as one of the industry's top workplaces, consistently earning accolades for its innovative culture and patient-focused approach to drug development.