Quality Operations Specialist

Job Summary

Required Qualifications

• •High School Diploma or GED
• •5 years of experience in a Quality role within a GMP-regulated facility
• •Bachelor's degree in Life Sciences, Chemistry, Biology, Engineering, or a related field
• •2 years of experience in a Quality role within a GMP-regulated facility
• •Experience in pharmaceutical manufacturing, biologics, medical device, or other regulated manufacturing environments
• •Experience in quality assurance or operations within GMP environment
• •Experience with batch record review
• •Familiarity with SAP or other ERP systems
• •Strong working knowledge of cGMP, GDP, and FDA/EMA regulatory expectations
• •Understanding of pharmaceutical manufacturing processes and cleanroom operations
• •Familiarity with batch record documentation and data integrity principles
• •Strong attention to detail and documentation accuracy
• •Effective communication and on-the-floor coaching ability
• •Ability to identify compliance gaps and drive immediate corrective actions
• •Organizational and time-management skills
• •Strong verbal and written communication skills
• •Strong interpersonal skills with the ability to collaborate across functions and levels
• •Problem-solving and root cause analysis capabilities
• •Ability to make sound quality decisions in real time
• •Ability to work effectively in controlled manufacturing environments
• •Ability to balance compliance requirements with operational efficiency
• •Ability to collaborate cross-functionally and escalate issues appropriately
• •Ability to work independently to consistently meet daily and weekly expectations
• •Ability to stand and walk for 10 hours or more per day
• •Ability to wear appropriate personal protective equipment (PPE) as required
• •Adherence to all Good Manufacturing Practices (GMP) Safety Standards
• •Cleanroom: no hair products, jewelry, makeup, nail polish, perfume, exposed piercings, facial hair etc... allowed
• •Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.)
• •Shift: FOWD (Front of week Days) (Monday-Wednesday 6:00am-6:30pm)
• •Perform alternating or rotating shift work (as required)
• •Serve as Senior QA point of contact for Quality RAPID events
• •Facilitate path-forward and disposition determination
• •Ensure sufficient data is collected to support complete and accurate deviation report generation
• •Author clear, thorough, and scientifically sound deviation reports
• •Partner with QA Management, Operations, Technical Services, Engineering, and other SMEs
• •Collaborate with Client QA to review deviation report feedback
• •Track deviation report progress through review, comment resolution, approval, and closure
• •Perform in-process QA checks prior to batch initiation for each manufacturing sub-phase
• •Perform cleaning & swab verification
• •Perform equipment functionality checks
• •Perform operator training checks
• •Perform GMP documentation checks
• •Support Change Control activities by creating, reviewing, and/or managing required batch record insert-pages
• •Perform manufacturing barrier checks including installation and removal verification
• •Support hold tag creation and removal activities
• •Perform associated SAP status changes
• •Provide consultation and guidance for process comments
• •Perform Fit & Finish audits of Manufacturing on an annual basis per FDA requirement
• •Maintain a safe working environment and report potential hazards

Desired Qualifications

• •Experience in pharmaceutical manufacturing, biologics, medical device, or other regulated manufacturing environments preferred
• •Experience with batch record review preferred
• •Familiarity with SAP or other ERP systems preferred