Operational Quality Specialist -QC

GlaxoSmithKline; Marietta (PA); Sur place; USD 90 000 - 115 000; Plein temps

Résumé du poste

GlaxoSmithKline seeks an Operational Quality Specialist for its Marietta, PA site to oversee QC SOPs, methods, deviations, CAPAs, and Change Controls. You will drive quality decisions across production and testing, ensuring patient safety and product quality with hands-on QA support.

The role collaborates with production, labs, engineering, and quality teams to uphold GMP standards, with emphasis on problem-solving, documentation, and regulatory compliance.

Qualifications

• Bachelor's degree in chemistry, biochemistry, pharmaceutical sciences, or related field.
• 2+ years of quality control experience and experience overseeing quality control testing.
• Hands-on experience with analytical equipment such as HPLC, GC-MS, TOC, FTIR, ELISA; knowledge of GMP and QA practices.
• Understanding of GMP, FDA regulations, and quality systems; ability to drive initiatives across multiple teams.
• Strong communication and problem-solving skills; capable of working in a complex matrix environment.

Responsabilités

• Provide oversight to QC quality system activities including Deviations, CAPAs, Change Controls, Validation, Analytical Method Transfers, Risk Assessment, and PQRs.
• Provide on-the-floor QA support and perform QA operations (documentation review, logbook review, etc.).
• Responsible for release of lab areas after Return to Service testing and QA oversight of Stability and Retention program at the Marietta site.

Connaissances

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

Formation

Bachelor's degree in chemistry, biochemistry, pharmaceutical sciences, or related field

Outils

HPLC

GC-MS

TOC

FTIR

ELISA

LIMS

Electronic Lab Notebooks

Description du poste

Business Introduction:

We manufacture and supply reliable, high-\-quality medicines and vaccines to meet patients' needs and drive our performance. Our network of 37 medicines and vaccines manufacturing sites delivered 1.7 billion packs of medicines and 409 million vaccine doses in 2024 to help make a positive impact on the health of millions of people. Our supply chain is not just core to our operations; it's vital to bringing our innovations to patients as efficiently and effectively as possible. Technology is transforming how we manufacture medicines and vaccines, enabling us to increase the speed, quality and scale of product supply. We need the very best minds and capability to help us on our journey to make more complex products, harnessing the power of smart manufacturing technologies including robotics, digital solutions and artificial intelligence to deliver for patients.

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. Join us as an Operational Quality Specialist 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. We seek proactive problem-solvers who communicate openly and foster a strong quality culture. This role offers you growth, learning, and a chance to contribute to GSK's mission of uniting science, technology, and talent to get ahead of disease together.

Responsibilities:

This role will provide YOU the opportunity to lead key activities to progress YOUR career. These responsibilities include some of the following:

• Provide oversight to all QC related quality system activities and take initiative to resolve and/or elevate 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.

Principle Decisions and Complexity:

• Decisions made for Quality directly impact the quality and suitability of the products produced at the Marietta site including the release of clinical trial materials and commercial products. Decisions must be made in accordance with regulations of the USP, CFR, EP and FDA.
• Manage a high number of projects in parallel. Priorities can change very quickly due to new business opportunity or new sales projection. High adaptability required for ability to keep teams motivated when priorities change. Facilitate opposing views among departments to resolution.

Basic Qualifications:

We are seeking professionals with the following required skills and qualifications to help us achieve our goals:

• Bachelor's degree in chemistry, biochemistry, pharmaceutical sciences, or related scientific discipline. 2+ years of quality control experience and experience overseeing quality control testing..
• 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.Hands on experience with Aseptic Environmental Monitoring programs, microbiological testing methods, such as, Sterility test USP<71>, Endotoxin testing USP<85>, 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.
• Stay current on developments in the field and GSK\- Standards. Demonstrate a serious commitment to accuracy and quality while meeting goals or deadlines. This role is responsible for approving GMP quality control test methods for drug product and must understand the requirements for documentation related to QC testing.

Preferred Qualifications:

• 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.

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

Please visit GSK US Benefits Summary to learn more about the comprehensive benefits program GSK offers US employees.

Why GSK?

Uniting science, technology and talent to get ahead of disease together.

GSK is a global biopharma company with a purpose to unite science, technology and talent to get ahead of disease together. We aim to positively impact the health of 2.5 billion people by the end of the decade, as a successful, growing company where people can thrive. We get ahead of disease by preventing and treating it with innovation in specialty medicines and vaccines. We focus on four therapeutic areas: respiratory, immunology and inflammation; oncology; HIV; and infectious diseases - to impact health at scale.

People and patients around the world count on the medicines and vaccines we make, so we’re committed to creating an environment where our people can thrive and focus on what matters most. Our culture of being ambitious for patients, accountable for impact and doing the right thing is the foundation for how, together, we deliver for patients, shareholders and our people.

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GSK is an Equal Opportunity Employer. This ensures that all qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex (including pregnancy, gender identity, and sexual orientation), parental status, national origin, age, disability, genetic information (including family medical history), military service or any basis prohibited under federal, state or local law.

Please note that if you are a US Licensed Healthcare Professional or Healthcare Professional as defined by the laws of the state issuing your license, GSK may be required to capture and report expenses GSK incurs, on your behalf, in the event you are afforded an interview for employment. This capture of applicable transfers of value is necessary to ensure GSK's compliance to all federal and state US Transparency requirements. For more information, please visit the Centers for Medicare and Medicaid Services (CMS) website at https://openpaymentsdata.cms.gov/