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Senior QA Specialist

Location: 
Boston
Date Posted: 
02/22/2021
Employment Type: 
Contract
Job ID: 
11176
Description: 

POSITION SUMMARY

Key Knowledge/ Skills and Competencies

  • Ability to perform functions independently in accordance with cGMP guidelines.
  • Strong written and oral communication skills required
  • Good interpersonal skills required
  • Ability to work effectively and meet challenging timelines in a fast –paced and high throughput environment
  • Strong organizational skills, work ethics and respect for all customers.
    • Ability to independently coordinate with cross-functional teams
    • Ability to think strategically and tactically, balancing these as workload changes.
  • Attention to detail
    • Expert knowledge of global GMP requirements governing oral drug products and knowledge of oral drug product manufacturing practices
    • Proven experience supporting GMP manufacturing either via experience in manufacturing and /or process development or experience providing QA operational support of GMP manufacturing as a QA reviewer working with Batch Records or in QC Analytical role
    • Experience with release of incoming materials and materials management
    • Project management skills desirable
    • Medical device experience a plus

KEY RESPONSIBILITIES:             

  • As part of the GMP Operational Quality group primarily responsible with providing quality oversight and support to operations at the Vertex in the following key areas/activities; support of manufacturing operations across all phases of development and commercial, support of analytical laboratory operations, and materials management

Product Release – Internal Manufacturing

  • Responsible for reviewing batch data, including batch records, deviations, in-process data, EM data, QC release testing and other quality systems as applicable to determine acceptability of product disposition.
  • Responsible for dispositioned product labelling and coordinating with Materials Management to support product shipment.
  • Responsible for archival of batch records and other supporting documents in QDoCCs

Compliance Oversight of Internal Operations and Quality Systems

  • Provide production floor support and guidance on any manufacturing related issues for GMP Continuous and non-continuous product manufacturing.
  • Review and approval of Manufacturing documents (as required)
  • Responsible for raw material release, area clearance, line clearance and equipment release
  • Provide QA support of change controls, GMP investigations and CAPAs (as required).  Responsible for updating QA database to support generating performance metrics, trends.
  • Participate in compliance walkthroughs and help drive the closure of any observations
  • Responsible for identifying risks and communicating gaps for GMP process/systems
  • Responsible for identifying risks and communicating any gaps for quality processes optimization for area/equipment release, material disposition, quality systems etc.
  • Participate in inspection readiness and support activities (as necessary)
  • Participate in process improvement initiatives (as necessary).
  • Act as a trusted advisor to the site by providing compliance guidance through collaborative review and working with the business owners to gain a better understanding of their needs and facilitate resolution of quality issue in a timely manner

REQUIRED EDUCATION AND EXPERIENCE:

  • Demonstrated success by independently coordinating with cross-functional teams
  • Experience providing QA support and oversight of Material Management operations including incoming material release.
  • Experience with drug product (oral solid dosage forms preferred) development and manufacturing with proficient knowledge of the following in a pharmaceutical setting:
    • cGMP’s and associated CMC regulatory considerations
    • experience with continuous manufacturing a plus
  • Experience with network based applications such as Oracle, TrackWise, VeeQMS
  • Experience providing QA support and oversight of GMP manufacturing operation including batch release
  • Master’s degree with 2-3 years of relevant work experience, or Bachelor’s degree in a scientific or allied health field with minimum 5 years of relevant work experience, or relevant comparable background.