Quality Control Senior Specialist

Job Description

Employer: Vertex Pharmaceuticals Incorporated 

JOB TITLE: Quality Control Senior Specialist

LOCATION: Harbor Street, Boston, Massachusetts, 02210

OPENINGS:

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 Bachelor's 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 inspections. In-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: $ $

CONTACT: Send Resume to Reference EOE.

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Pay Range:

Disclosure Statement:

The range provided is based on what we believe is a reasonable estimate for the base salary pay range for this job at the time of posting. This role is eligible for an annual bonus and annual equity awards. Some roles may also be eligible for overtime pay, in accordance with federal and state requirements. Actual base salary pay will be based on a number of factors, including skills, competencies, experience, and other job-related factors permitted by law.

At Vertex, our Total Rewards offerings also include inclusive market-leading benefits to meet our employees wherever they are in their career, financial, family and wellbeing journey while providing flexibility and resources to support their growth and aspirations.  From medical, dental and vision benefits to generous paid time off (including a week-long company shutdown in the Summer and the Winter), educational assistance programs including student loan repayment, a generous commuting subsidy, matching charitable donations, 401(k) and so much more.

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 Vertex's 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 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.

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