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SalaryJob Description
General Summary:
The Senior Quality Specialist is recognized as an expert internally in the principles and application of quality assurance and compliance. The Senior Quality Specialist coordinates GMP activities in support of clinical and commercial Drug Product manufacturing and disposition.
*** This is an on-site position on the 2nd Shift. ***
KEY DUTIES AND RESPONSIBILITIES:
- Review batch data, including batch records, deviations, in-process data, EM data, QC release testing and other quality systems.
- Responsible for approval of COAs, generating BSE/TSE statement and product labelling.
- Responsible for archival of batch records and other supporting documents in electronic Document Management System (eDMS).
- 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 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.
- Participate in compliance walkthroughs and help drive the closure of any audit 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 and ongoing Project (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 leading cross-functional teams
- Experience providing QA support and oversight of GMP manufacturing operation including equipment/ facilities qualification, utilities and batch release.
- Experience successfully leading event investigations, Root Cause Analysis and CAPA Experience with network based applications such as Oracle, Veeva
- 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.
On-Site Roles
In this 2nd Shift, On-Site designated role, you will work five days per week on-site with ad hoc flexibility.
#LI-Onsite #AR-1
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 at ApplicationAssistance@vrtx.com.
