Operational Quality Specialist -QC

Position Summary

Oversee all Quality Control (QC) SOPs, QC Methods, unplanned events, Change Controls, CAPAs, continuous method validation, and QMS events for drug substance quality control activities. Drive excellence in Quality Control. You will be at the heart of ensuring high-quality standards are met across manufacturing and testing operations. Working closely with production, laboratories, engineering, and quality teams, you'll protect product quality and patient safety through clear decisions and hands-on support.

Responsibilities

• Provide oversight to all QC related quality system activities and take initiative to resolve and/or escalate concerns including Deviations, CAPAs, Change Controls, Validation, Analytical Method Transfers, Risk Assessment, and PQRs.
• Provide advice and counsel on cGMP and related quality assurance issues to QC managers and personnel.
• Demonstrated familiarity and compliance with GMPs, EHS procedures and regulations, facility regulatory guidelines and standard operating procedures.
• Provide on the floor QA support and perform QA Operation's activities (documentation review, logbook review, facility cleaning records for quarterly walkthroughs).
• Responsible for release of the rooms after the Return to Service testing for the lab areas and for status changes of lab areas in response to maintenance work or unplanned events.
• Responsible for QA oversight of the Stability and Retention program for the GSK Marietta site.
• Manage a high number of projects in parallel; high adaptability required when priorities change.
• Facilitate opposing views among departments to resolution.

Basic Qualifications

• Bachelor's degree in chemistry, biochemistry, pharmaceutical sciences, or related scientific discipline.
• 2+ years of quality control experience and experience overseeing quality control testing.
• Hands on experience with Aseptic Environmental Monitoring programs, microbiological testing methods, such as Sterility test USP , Endotoxin testing USP , Bioburden testing.
• Experience in quality systems, Quality Control Laboratories, including validation, documentation, compliance in a high volume, rapid turnaround release office or compliance department.
• Understanding of industry and science practices related to the business.
• Versed in GMP's, NIH Guidelines, FDA and other regulatory agency requirements for validation and operations, analytical and stability functions and compliance.
• Demonstrated ability to drive initiatives across multiple business units under tight deadlines.
• Strong communication and problem-solving skills with demonstrated ability to work well with and influence others without direct reporting relationships.
• Ability to work in a high complex matrix environment with a sense of urgency, flexibility and accountability.
• Must be a committed team player prepared to work in and embrace a multi-skilled team-based culture.
• Proven record of providing excellent internal and external customer service.
• Demonstrate a serious commitment to accuracy and quality while meeting goals or deadlines.
• Responsible for approving GMP quality control test methods for drug product and must understand the requirements for documentation related to QC testing.

Preferred Qualifications

• Prior experience with licensed biopharmaceutical or biological products preferred.
• Hands on experience using Analytical laboratory equipment/systems, such as HPLC, GC-MS, TOC, FTIR, ELISA is preferred.
• Experience in a pharmaceutical or biologics manufacturing environment focusing on drug substance or product testing.
• Knowledge of laboratory information management systems (LIMS) or electronic lab notebooks.
• Training or experience in root cause analysis and structured investigation techniques.
• Experience supporting regulatory inspections and audit readiness activities.
• Ability to influence and coach laboratory staff and cross-functional teams on quality behaviors.
• Comfortable working in a fast-paced environment with multiple priorities.

Work Arrangement

This role is on-site at a United States manufacturing location. Regular presence in production and laboratory areas is required. Hybrid or remote work is not available.