GMP Operational Quality, Senior Specialist (Contract) 25048

The GMP Operational Quality Senior Specialist Contractor supports the principles and application of quality assurance and regulatory compliance. The incumbent supports or executes a wide range of activities and supports new/existing project initiatives. The GMP Operational Sr. Quality Specialist Contractor is recognized as a subject matter expert in the principles and application of quality assurance and compliance. The Sr. Quality Specialist Contractor coordinates GMP activities in support of commercial disposition. This position reports directly to the Senior Manager, GMP Operational Quality.

Responsibilities:

• Participates in cross-functional teams as a Quality technical resource responsible for providing quality oversight and support to manufacturing operations.
• Enforces Quality Agreements between CMOs/Suppliers, as needed
• Assists Change Control owners with ensuring compliance to change procedure requirements
• Supports change control assessments, implementation, approval, and closure
• Supports quality investigations /deviations and reviews corrective action plans for adequacy and compliance. This includes root cause analysis and product impact assessments for investigations resulting from deviations and OOS. 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.
• Ensures appropriate CAPA actions are identified and addressed.
• Approves investigations/CAPAs.
• Maintains Quality Metrics to support on time release deliverables
• Conducts GMP document review, including Master Batch Records, Executed Batch Records, Validation Protocols and Reports
• Identify and communicate risks and assist with risk mitigation plans as necessary
• Identifies and facilitates continuous improvement efforts
• Helps represents on cross-functional working teams, applying strong communication and collaboration skills.
• Support continuous improvement projects

 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 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

Qualifications:

• Bachelor's degree in scientific or allied health field (or equivalent degree)
• Requires 3 years of experience, or the equivalent combination of education and experience
• Experience providing Quality support and oversight of GMP manufacturing operation including batch release
• Experience with drug substance and drug product (oral solid dosage forms preferred) development and manufacturing with proficient knowledge in a pharmaceutical setting
• Knowledge of cGMP requirements governing oral drug products manufacturing practices
• Proficient in leading event investigations, Root Cause Analysis (RCA), and CAPA