Operational Quality Specialist

GSK•Marietta, PA

5d•Onsite

About The Position

You will provide operational quality oversight at a United States manufacturing site. You will work closely with production, laboratories, engineering and quality teams to keep processes compliant, safe, and reliable. 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. To maintain presence and be accountable for batch record review and approval, key quality decision-making, and quality escalations. To be a liaison between operations and the site QA Systems, QA Compliance and QA Product Release (QAPR) departments. We value practical problem solvers who make clear decisions and coach others. This role offers hands-on learning, visible impact on product quality, and growth opportunities that align with our mission of uniting science, technology and talent to get ahead of disease together.

Requirements

Bachelor’s degree in biology, chemical engineering, life sciences field or a bachelor's degree in another discipline is acceptable if technical depth has been achieved from professional experience.
2 + years of experience in regulated industry.
Strong quality assurance background.
Experience working in pharmaceutical facilities, equipment, and quality systems.
1+ years of experience with GMP’s, NIH Guidelines, FDA and other regulatory agency compliance requirements sufficient to apply to quality operations and compliance.
Experience with validation principles, aseptic processing, quality systems and FDA regulations.
Experience with training in DMAIC root cause analysis methodology.
Experience reviewing batch records and GMP documentation.

Nice To Haves

Experience in biologics manufacturing is strongly preferred.
Experience in biologics or pharmaceutical manufacturing environments with deviations, CAPA, change control, and validation activities.
Training or experience in root cause analysis methods such as DMAIC or similar.
Familiarity with inspection readiness and regulatory agency expectations.
Demonstrated ability to influence cross-functional teams and coach others on quality behaviors.
Comfortable working in a fast-paced environment and prioritizing competing demands.
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 and issues within high paced environment.
Be a team player prepared to work in and embrace a multi-skilled team-based culture.

Responsibilities

Ensure that all GMP processes and operational personnel adhere to current GMP, applicable regulatory requirements, and procedures, minimizing risk of non-compliance and maintaining inspection readiness at all times.
Maintain shopfloor oversight across area of responsibility and be the first line of contact to support initial management of quality issues, demonstrate quality decision-making, and provide quality escalations as needed.
Provide guidance during GMP activities to proactively detect potential quality issues through active observation in real-time, allowing for timely interventions to prevent deviations and defects.
Perform a spot-check of activities across production and laboratory areas to ensure compliance with quality standards that includes production, testing, cleaning and maintenance activities.
Carry out review of cGMP documentation and records ensuring that the content meets defined criteria, exceptions have been appropriately addressed, and Good Documentation Practice (GDP) is being maintained following ALCOA+ principles for data integrity, audit and traceability. Review and final approve batch records and batch related documentation.
Provide review, initial impact approval, and final approval of deviations and associated CAPA plans. Provide review and approval of documentation which may include procedural revisions, logbooks, PQRs, customer complaint investigations, change controls, validation documents, etc.
Ensure all GMPs, validation, quality, safety and environmental regulations are met. Adhere to all safety guidelines and procedures.
Role model 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.
Provide on-the-floor quality oversight, perform regular shopfloor walk-throughs, and detect early quality risks. Review executed and master batch records, deviations, and CAPA plans for completeness and compliance.
Make or recommend disposition decisions and support lot release activities following defined procedures. Support and perform self-inspections, internal audits, and inspection readiness activities.
Review and approve GMP documentation including change controls, validation summaries, and procedural updates. Investigate quality issues, support root cause analysis, and help implement corrective and preventive actions.