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Job Description
The Senior Specialist works with a high degree of independence, while providing oversight of the development, implementation and maintenance of relevant quality initiatives in support of their function. The Sr. Specialist completes work in a resourceful, self-sufficient manner and can design alternative approaches to achieve desired outcomes. They are adept at troubleshooting problems, coordinating and executing activities on multiple complex projects ensuring alignment with corporate goals and compliance with all regulatory requirements.
Key Responsibilities:
The responsibilities of this position may include, but are not limited to, the following:
- Perform disposition activities for Finished Goods in support of Clinical/Commercial Product, including:
- Master and Executed Batch Record review and resolution of comments/issues
- Evaluations of Investigations/ OOS/ Change Controls to support Disposition Status
- Certificate of Analysis approval
- Status change in Oracle
- Archiving of batch documents in electronic document system
- Collaborative reviewer of internal procedures
- Support quality oversight of artwork/label review, approval, & implementation
- Provides quality guidance for root-cause analysis and product impact assessment for investigations as a result of deviations, OOS, and OOT investigations ensuring appropriate CAPA actions are identified
- Provide quality support for planning of product launches and tracking of new artworks
- Assist in packaging validation activities as needed
- Develops relationships with strategic external partners in support of Vertex’s expanding commercial portfolio and assist with ongoing relationships.
- QP Relationship and Release
- Facilitate Disposition of QP Release of finished goods
- Assist with QP Declaration requests
- Collaborative reviewer of internal procedures
- Establishment of Quality Processes/Process Ownership – Packaging /Labeling and QP Release of Finished Goods
- Serve as review/approver or owner of deviations
- Monitors and trends events and identifies/proposes corrective actions
- May serve as CAPA owner
- Identifies risks and communicates gaps to management
- Assists with the generation of process related metrics/monitors for efficiency
- Commercial Change Control
- Serve as QA assessor/approver: resolve gaps, approve change plans, classifications, strategy for GMP release and disposition strategy
- Maintain batch disposition spreadsheets, input data and extract metrics.
Key Requirements:
- Relevant degree
- Good communication skills and ability to engage with internal and external stakeholders
- Demonstrated ability to work independently to provide QA support for relevant projects
- Skilled in creating and maintaining spreadsheets in Excel, including the use of formulas and macros
- Knowledge of global GMP/GDP requirements governing oral drug products including exemption management and non-licence supply.
- Knowledge of packaging and labelling process and artwork requirements
- Investigation and Root Cause Analysis tools/methodology
- Audit process understanding
- Ability to assess when to escalate urgent requests
- Ability to take ownership and accountability for shared information
#LI-SM2
#LI-Hybrid
Flex Designation:
Hybrid-Eligible Or On-Site Eligible
Flex Eligibility Status:
In this Hybrid-Eligible role, you can choose to be designated as:
1. Hybrid: work remotely up to two days per week; or select
2. On-Site: 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.
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 [email protected]
