GMP Operational Quality Senior Specialist - Packaging/Labeling (Contract) 883
About The Position
The Sr. Specialist GMP QA Operations works with a high degree of independence to provide oversight of the development, implementation, and maintenance of quality initiatives. The Senior Specialist completes work resourcefully and self-sufficiently, develops alternative approaches to achieve desired outcomes, and troubleshoots issues while coordinating and executing multiple complex projects in alignment with corporate goals and regulatory requirements. The role focuses on GMP packaging and labeling, batch review and release, and oversight of contract manufacturing organizations (CMOs) and external vendors in a commercial drug environment. It supports batch disposition, investigation and change-control activities, continuous improvement, and collaboration with cross-functional teams.
Requirements
- Bachelor’s degree in a scientific or allied health field, or equivalent degree.
- Experience in batch release, a GMP environment, or an equivalent combination of education and experience.
- Experience supporting multiple projects or teams within stated objectives and timelines.
- Ability to support cross-functional team members and collaborate effectively.
- Good written and verbal communication skills, including the ability to exchange potentially complex information.
- Ability to integrate activities with other groups, departments, and project teams as needed.
- Demonstrated ability to evaluate quality matters and solve straightforward problems using technical experience and judgment based on precedent.
- Ability to work in a fast-paced environment and meet quality, accuracy, and timeliness objectives.
- Expanded conceptual knowledge of cGMPs in a pharmaceutical setting.
- Proficiency in leading event investigations, root-cause analysis (RCA), and CAPA.
Nice To Haves
- Ample experience in Quality and GMP packaging/labeling.
- Experience with batch review and release.
- Experience with CMOs or external vendors in a commercial drug environment.
Responsibilities
- Review master and executed batch records and resolve comments or issues.
- Archive batch documents in an electronic document system.
- Track data for metrics generation.
- Evaluate investigations, OOS results, and change controls to support disposition status.
- Make disposition decisions and update status in Oracle.
- Support quality oversight of root-cause analysis and product-impact assessments for investigations resulting from deviations, OOS, and OOT, ensuring appropriate CAPA actions are identified.
- Support change-control assessments, implementation, and closure.
- Identify and facilitate continuous-improvement efforts and support continuous-improvement projects.
- Support drafting and revising Quality Agreements between CMOs or suppliers and Vertex, as needed.
- Represent Vertex Quality on cross-functional working teams and collaborate with team members.
Benefits
- Overtime pay in accordance with federal and state requirements.
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What This Job Offers
Career Level
Senior
