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Senior Specialist, Quality Commercial Finished Goods Batch Disposition (Hybrid)

Semma Therapeutics

Semma Therapeutics

Quality Assurance
Boston, MA, USA
Posted on Monday, March 25, 2024

Job Description

General Summary:

The Sr. Specialist GMP QA Operations 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 Senior Specialist completes work in a resourceful, self-sufficient manner and is able to 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 Duties and Responsibilities:

  • Master and Executed Batch Record review and resolution of comments/issues

  • Archiving of batch documents in electronic document system

  • Track data for the purpose of metrics generation

  • Evaluations of Investigations/ OOS/ Change Controls to support Disposition Status for Finished Goods.

  • Disposition Decision and status change in Oracle

  • Support packaging and labeling components/BOM, review and approval.

  • Supports quality oversight 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.

  • Supports change control assessments, implementation and closure

  • Identifies and facilitates continuous improvement efforts

  • Supports drafting and revising Quality Agreements between CMOs/Suppliers and Vertex, as needed

  • Helps represents Vertex Quality on cross-functional working teams, applying strong communication and collaboration skills.

  • Support continuous improvement projects

Knowledge and Skills:

  • Experience supporting multiple projects/teams within stated objectives and timelines

  • Experience supporting cross-functional team members and collaborate effectively

  • Good communication skills (written and verbal) and the ability to exchange potentially complex information

  • Able to integrates activities with other groups, departments and project teams as needed

  • Demonstrated ability to support evaluation of quality matters and solve straightforward problems using technical experience and judgement based on precedent

  • Ability to work in a fast-paced environment and meet quality, accuracy, and timeliness objectives

  • Expanded conceptual knowledge of cGMP's in a pharmaceutical setting

  • Proficient in leading event investigations, Root Cause Analysis (RCA), and CAPA

Education and Experience:

  • Bachelor's degree in scientific or allied health field (or equivalent degree)

  • Requires experience in batch release, GMP environment, or the equivalent combination of education and experience

Hybrid-Eligible Roles

In this Hybrid-Eligible role, you can choose to be designated as:

Hybrid: work remotely up to two days per week; or select On-Site: work five days per week on-site with ad hoc flexibility.

#LI-Hybrid #LI-AR1

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.