Job Description:


The Quality Specialist is recognized as an expert internally in the principles and application of quality assurance and compliance. The Quality Specialist coordinates GMP activities in support of clinical and commercial Drug Product disposition. This position reports to Sr. QA Manager
Key Leadership Skills
Cross- functional collaborator
Results Driver
Key Knowledge/ Skills and Competencies
  • Strong leadership skills with the ability to thrive in a high throughput environment
  • Collaboration / Teamwork
  • Ability to independently lead cross-functional teams and represent the Quality unit
  • Communication
  • Ability to communicate effectively across all organizational levels
  • Critical Thinking / Problem Solving
  • Ability to evaluate quality matters and make decisions utilizing risk based approach
  • Adaptability
  • Should be flexible to work 2nd shift as per the business needs
  • Attention to detail
  • Knowledge in the following areas:
  • Expert knowledge of GMP requirements governing oral drug products manufacturing practices
  • Proven experience supporting GMP manufacturing either via experience in manufacturing and /or experience providing QA operational support of GMP manufacturing
KEY RESPONSIBILITIES:
As part of the Quality Operations and Compliance 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
Responsible for batch disposition. Review 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 approval of COAs, generating BSE/TSE statement and product labelling
Responsible for archival of batch records and other supporting documents in QDoCCs
Responsible for generating performance metrics for disposition
Provide production floor support and provide guidance for GMP product quality and compliance for product release, including resolution of product quality investigations and quality issues of a significant nature, and provides direction for product disposition decisions including shipment
Review and approval of Manufacturing documents
Responsible for raw material release, area clearance, line clearance and equipment release
May be required to assist the QA Engineering group with activities associated with equipment, instrument, utilities, and/or facility qualification activities including change control, and support of site programs
Provide QA support of change controls, GMP investigations and CAPAs. Responsible for 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 continuous improvements of department processes.
Participate in inspection readiness and support activities
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

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Qualification:

Demonstrated success by independently leading cross-functional teams

Experience providing QA support and oversight of GMP manufacturing operation including batch release

Experience with drug product (oral solid dosage forms preferred) development and manufacturing with proficient knowledge of the following in a pharmaceutical setting: o cGMP s and associated CMC regulatory considerations ; experience with continuous manufacturing a plus

Experience successfully leading event investigations, Root Cause Analysis and CAPA

Experience with network based applications such as Oracle, TrackWise

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


Associated topics: bacteria, clinical, drug, drug discovery, histologist, histology, microbiological, nephrology, pharmacometrics, transfection

* The salary listed in the header is an estimate based on salary data for similar jobs in the same area. Salary or compensation data found in the job description is accurate.

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