Quality Control Specialist - MES

About the role

To ensure adherence to cGxP standards and procedures through the independent oversight of GxP processes. To improve the effectiveness of quality in preventing/identifying and addressing quality issues by encouraging proactive quality culture and continuous improvement. Directly support Operational through 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. You will work closely with manufacturing, engineering, IT, and quality teams to keep processes compliant and data trustworthy. We value clear decision makers who coach others and act with integrity. This role offers hands-on learning, visible impact, and clear career growth aligned with our mission of uniting science, technology and talent to get ahead of disease together.

Responsibilities

• Provide operational QA oversight for MES workflows, electronic batch records, and system-controlled manufacturing steps.
• Ensure that all GMP processes and operational personnel adhere to current GMP, validation, quality, safety and environmental regulations are met maintaining inspection readiness at all times.
• Review eCC, TCD and/or other QS change for impact to: Master Data (Equipment, sMBR, Workstations, Workcenters). Main-PI, Sub-PI design/validation
• Review and approve creation and/or updates to master data: Equipment Spec File (as QA Master Data) sMBR (as sMBR QA Reviewer) including integration with SAP and OsiPi
• Review and approve creation and/or updates to URS and Design of Main-PI, Sub-PI (as QA PI Reviewer and QA Ops, as applicable) Including integration with SAP and OsiPi
• Approval of Validation Form for Main-PI, Sub-PI pre and post-execution (as QA PI Reviewer) including applicable incident management and including integration with SAP and OsiPi
• GxP, DI, Business Continuity Risk Assessments, PI inventory
• IO/PQ protocol and report, including applicable validation impact assessment/unplanned events (as QA PI Reviewer and QA Ops, as applicable).
• Audit Trail Reviews
• Develop/Approve MES LSOPs and associated child documents
• Provide review, initial impact approval, and final approval of deviations and associated CAPA plans, logbooks, PQRs, customer complaint investigations, change controls, validation documents, etc.
• Role model the GPS standards and foster a 'Quality Starts With Me' culture by providing coaching to employees on the importance of following procedures, doing the right thing and explaining the why and the impact non-compliance can have on product quality and patient safety.
• Perform regular shopfloor and system walkthroughs to identify risks and coach teams on good documentation and data integrity.
• Lead or support investigations for deviations, system incidents, and data anomalies, including root cause analysis and CAPA follow-up.
• Review and approve change controls, validation summaries, and procedural updates that affect MES or digital records.
• Support inspection readiness, internal audits, and regulatory questions related to computerized systems and digital records.
• Monitor MES-related quality KPIs and trends and recommend process or system improvements.

Basic Qualifications

• Bachelor's degree in Life Sciences, Biology, Chemical Engineering. A bachelor's degree in other disciplines may be acceptable if sufficient technical depth has been achieved from experience.
• Minimum 3 years' experience in regulated industry preferably in Quality Assurance.
• Must have prior MES implementation experience.
• Requires understanding and experience with pharmaceutical facility, equipment and systems. Including technical understanding of industry and science practices related to the business in order to apply knowledge to daily activities.
• Experienced with GMP's, NIH Guidelines, FDA and other regulatory agency compliance requirements sufficient to apply to quality operations and compliance, with knowledge of validation principles, aseptic processing, quality systems and FDA regulations.
• Training and work experience in DMAIC root cause analysis methodology.
• Must have 1+ year of hands-on experience with Good Manufacturing Practices and Good Documentation Practices.

Preferred Qualifications

• Experience in biologics manufacturing preferred.
• Familiarity with electronic records guidance such as 21 CFR Part 11 or Annex 11.
• Hands-on experience supporting system validation (IQ/OQ/PQ) or computerized system lifecycle tasks.
• Experience with LIMS, electronic batch records, or other digital manufacturing solutions.
• Training and work experience in DMAIC root cause analysis methodology.
• Well-developed interpersonal skills and decision-making capabilities with the ability to influence different levels of the Site and Quality organization.
• Ability to deliver clear communications (written and verbally), coaching, foster a 'Quality Starts With Me' culture and work with a spirit of continuous improvement.
• Ability to facilitate and generate the exchange of ideas to resolve problems, prioritize solutions, select optimal quality solutions and implement decisions.
• Time management skills and ability to prioritize and respond to operational needs/issues within high paced environment.
• Training or experience in root cause analysis and CAPA methodologies.
• Demonstrated ability to influence cross-functional teams and coach colleagues on quality and data practices.

Skills

• Data Integrity
• Detail-Oriented
• Digital Fluency
• GxP Regulations
• Influencing Without Authority
• Lean Management
• Pharmaceutical Regulatory Compliance
• Problem Solving
• Quality Assurance (QA)
• Risk Awareness
• Technical Writing