Operational Quality Specialist

GSK•Marietta, PA

8d•Onsite

About The Position

This role will ensure adherence to cGxP standards and procedures through the independent oversight of GxP processes. The goal is to improve the effectiveness of quality in preventing, identifying, and addressing quality issues by encouraging a proactive quality culture and continuous improvement. The position requires maintaining a presence and accountability for batch record review and approval, key quality decision-making, and quality escalations. It also serves as a liaison between operations and the site QA Systems, QA Compliance, and QA Product Release (QAPR) departments. This role is on-site at a US manufacturing site and requires regular presence in production and laboratory areas.

Requirements

Bachelor’s degree in a scientific, engineering, or technical discipline; or an associate degree in a related field combined with a minimum of two years of relevant experience.
2+ years of experience in a regulated life sciences manufacturing or quality role.
Knowledge of Good Manufacturing Practices (GMP) and good documentation practices.
Experience reviewing batch records and GMP documentation.

Nice To Haves

A sound knowledge of pharmaceutical facilities, equipment, and quality systems.
Knowledge of GMP’s, NIH Guidelines, FDA and other regulatory agency compliance requirements sufficient to apply to quality operations and compliance.
Working knowledge of validation principles, aseptic processing, quality systems and FDA regulations.
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.
Be a team player prepared to work in and embrace a multi-skilled team-based culture.
Strong observational skills and the ability to make timely quality decisions on the shopfloor.
Clear written and verbal communication skills and the ability to work effectively across teams.

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 GSK safety guidelines and procedures.
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.