Senior Specialist, GMP Operational Quality

Overview

Senior Specialist, GMP Operational Quality

Join to apply for the Senior Specialist, GMP Operational Quality role at Katalyst CRO

The ideal candidate will possess a working knowledge of early phase to commercial GMP drug substance and drug product manufacturing regulations and good written and verbal communication skills. Prior Quality experience supporting multiple projects and teams involved in drug development activities.

• Supports quality oversight for root-cause analysis and product impact assessment for investigations as a result associated with 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 Company, as needed.
• Helps represent Company Quality on cross-functional working teams, applying strong communication and collaboration skills.
• Support continuous improvement projects.
• Performs the review of executed batch documentation from external and/or internal manufacturing and testing (executed batch records, release data, in-process controls, testing and stability data).
• Use knowledge of functional area to inform decisions and support the success of batch disposition for drug substance, drug product intermediate, drug product and finished goods.
• Supports GMP document review, including certificate of analysis, specifications.

• Bachelor's degree in a scientific or allied health field (or equivalent degree) and 2 years of relevant work experience, or equivalent combination of education and experience.
• 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 integrate 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.
• Operational QA experience in analytical or manufacturing setting with experience in small molecule manufacturing.
• Experience with biologics, devices, gene therapy a plus.
• Practical GxP knowledge and understanding across lifecycle of the product including the application of GMP regulations and application to Manufacturing.
• Root Cause Analysis methodology and tools.
• Analytical techniques and data review.
• Ability to evaluate routine quality matters and make decisions utilizing risk-based approach.
• Ability to communicate cross-functionally to a wide variety of audiences.
• Relationship management/conflict management skills.

• Entry level

• Contract

• Quality Assurance
• Industries
• Pharmaceutical Manufacturing

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