GMP Operational Quality Senior Specialist - Packaging/Labeling (Contract) 883
About The Position
The Senior Specialist, GMP QA Operations works with a high degree of independence to oversee the development, implementation, and maintenance of quality initiatives. The role requires resourcefulness, self-sufficiency, sound troubleshooting, and the ability to coordinate multiple complex projects in alignment with corporate goals and regulatory requirements. The ideal candidate has substantial experience in Quality, GMP packaging and labeling, batch review and release, and working with external contract manufacturing organizations (CMOs) in a commercial drug environment. This position supports Vertex Quality operations, including batch documentation review and disposition, investigation and change-control assessments, quality oversight, and continuous improvement. The role is a temporary assignment through a third-party agency partner. The stated pay rate is $65 per hour, and the role is eligible for overtime in accordance with federal and state requirements.
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.
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, out-of-specification (OOS) matters, and change controls to support disposition status.
- Make disposition decisions and change status in Oracle.
- Support quality oversight of root-cause analysis and product impact assessments for investigations arising from deviations, OOS, and out-of-trend (OOT) investigations, ensuring appropriate CAPA actions are identified.
- Support change-control assessments, implementation, and closure.
- Identify and facilitate continuous improvement efforts and support continuous improvement projects.
- Help draft and revise Quality Agreements between CMOs or suppliers and Vertex as needed.
- Represent Vertex Quality on cross-functional working teams, using strong communication and collaboration skills.
Benefits
- Overtime pay in accordance with federal and state requirements.
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What This Job Offers
Career Level
Senior
