Description
We are seeking an Operational Quality Specialist - MES to ensure adherence to cGxP standards and procedures through independent oversight of GxP processes. The successful candidate will improve the effectiveness of quality in preventing, identifying, and addressing quality issues by encouraging a proactive quality culture and continuous improvement.
The role involves directly supporting Operations through the development, review, and approval of MES-related design, implementation, and performance management tasks. You will provide operational quality assurance for Manufacturing Execution System activities that support drug product manufacturing, working closely with manufacturing, engineering, IT, and quality teams to keep processes compliant and data trustworthy.
Key responsibilities include:
- Providing operational QA oversight for MES workflows, electronic batch records, and system-controlled manufacturing steps
- Ensuring GMP processes and operational personnel adhere to current GMP, validation, quality, safety, and environmental regulations
- Reviewing and approving creation and/or updates to master data, URS and Design of Main-PI, Sub-PI, and validation documents
- Leading or supporting investigations for deviations, system incidents, and data anomalies
- Supporting inspection readiness, internal audits, and regulatory questions related to computerized systems and digital records
The ideal candidate will have:
- A Bachelor's degree in Life Sciences, Biology, Chemical Engineering, or a related field
- Minimum 3 years' experience in a regulated industry, preferably in Quality Assurance
- Prior MES implementation experience
- Understanding and experience with pharmaceutical facilities, equipment, and systems
- Experience with GMPs, NIH Guidelines, FDA and other regulatory agency compliance requirements
We offer a comprehensive benefits program, including various perks and opportunities for career growth.