Quality Control Senior Specialist

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 in an efficient and cGMP compliant manner while fostering the Vertex vision and values.
• Serve as RSL representative in cross-functional cross-departmental working teams and/or working 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/or equipment qualification/requalification
• Assist in troubleshooting of analytical methods and/or equipment as required.
• Authors reviews and/or approve data SOPs COAs analytical methods protocols and reports.
• Lead compliance related teams working towards the goal of continuous improvement.
• Perform in-process release and stability testing and/or review independently following established methodology procedures and SOPs.
• Lead the OOS/OOT investigations/deviations and to identify corrective actions to prevent reoccurrence.

REQUIREMENTS: Employer will accept a Bachelors degree or foreign equivalent in health science pharmaceutical sciences or a related field and 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 US and EU cGMP regulations guidance and experience with regulatory agency -process release and stability testing and review independently following established methodology procedures and SOPs. Participating in analytical method validation protocol discussions and lead planning and execution and review of method validations and method transfers. Ensuring accurate laboratory records and adhering to cGMP/GDP expectations. Troubleshooting analytical methods and analytical equipment as required. Investigating OOT/OOS results and other deviations. Knowledge of analytical methodologies including

HPLC with Empower software.

Karl Fisher.

Dissolution.

FTIR spectrophotometry.

UV-VIS Spectrophotometer.

Rate of Pay: $94300.00 - $141400.00

CONTACT: Send Resume to . Reference 12140.644. EOE.

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Pay Range:

Disclosure Statement:

Flex Designation:

Flex Eligibility Status:

In this On-Site designated role you will work five days per week on-site with ad hoc flexibility.

Note: The Flex status for this position is subject to Vertexs Policy on Flex @ Vertex Program and may be changed at any time.

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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 persons 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.

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