Vertex Inc.-posted 10 days ago
$94,300 - $141,400/Yr
Full-time • Mid Level
Onsite • Boston, MA
1,001-5,000 employees

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.

  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
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