Manufacturing Specialist

GSK•Marietta, PA

23d

About The Position

This Manufacturing Specialist will provide support to the DP (Drug Product) Value Stream in Quality Systems, GPS (Good Practice Standards) and improvement implementations, authoring/coordinating/executing Quality Systems items (deviations, change controls, CAPAs (Corrective and Preventive Action). As a Manufacturing Specialist at GSK, you will play a key role in ensuring the production of high-quality products that make a meaningful impact on patients’ lives. You will work in a collaborative environment, supporting manufacturing operations, troubleshooting processes, and driving continuous improvement initiatives. This role will provide YOU the opportunity to lead key activities to progress YOUR career, these responsibilities include some of the following: Ensure compliance with GSK safety, quality (GMP - Good Manufacturing Practice) and operational standards; participate in and enforce safety guidelines and procedures. Lead and support investigations into process deviations, perform troubleshooting, identify root causes, and implement corrective and preventive actions (CAPAs) to prevent recurrence. Support manufacturing operations and new product introductions by providing technical expertise and collaborating with cross-functional teams. Drive continuous improvement initiatives (Kaizen, Value Stream activities): assess processes, suggest and implement method/equipment/layout improvements, and participate in related projects. Author, review, revise and approve GMP documentation including Standard Operating Procedures (SOPs), batch records and operational readiness documents; ensure timely assignment and maintenance of compliance records for the Maintenance Department. Provide technical support for change controls, gap and risk assessments, and other quality/technical governance activities; author and coordinate required documentation. Monitor production/process performance, identify opportunities to improve efficiency and reduce waste, and support implementation of solutions. Provide training and technical guidance to operations teams to ensure consistent, high-quality manufacturing practices. Manage procurement and vendor interactions: assist in sourcing, ordering, tracking and liaising with vendors to ensure timely delivery of supplies, equipment and services; resolve discrepancies. Maintain accurate departmental records and data: enter and update purchase orders, inventory, invoices, compliance documents and other administrative records in relevant systems (e.g., ERP, Excel); keep organized digital and physical records for audits. Prepare, review and distribute administrative documentation (purchase requisitions, vendor correspondence, internal reports) ensuring completeness, timeliness and compliance with company policies. Interface with users, peers and management to align local and corporate standards and ensure appropriate input and integration across teams.

Requirements

Bachelor’s degree in a scientific discipline
1+ years of experience in a regulated manufacturing environment, such as pharmaceutical or biopharma.
Experience of Good Manufacturing Practices (GMP) and quality systems, including deviation investigation, change management, and corrective actions.
Problem-solving skills and experience with root cause analysis methodologies.
Experience in Microsoft Office applications, including Excel, Word, and PowerPoint.
Work collaboratively in a team-based environment.

Nice To Haves

Constructive, energetic and self-driven professional, a doer and problem solver, that takes the right time for assessment and then focuses on execution with a sense of urgency.
Experience of cGMPs, and to quickly grasp and apply site policies and procedures and relate them to project scope.
Interpersonal skills.
Experience to function within team-based organization.
Analyse information, problems, situations, practices or procedures; define and identify the concerns or factors.
Experience managing projects in order to achieve deliverables and adhere to timelines and budgets.
Prioritize and decide appropriate course of actions and implementing decisions.
Communicate both verbally and in writing with all levels of the organization, as well as, the skills to communicate site operations to outside agencies.
Communicate complex ideas and concepts in a clear, compelling way.
Experience with process improvement methodologies, such as Lean or Six Sigma.
Experience with production equipment systems and process diagrams.
Experience with new product introduction or technology transfer.
Experience managing multiple priorities and meet deadlines.
Experience with Enterprise Resource Planning (ERP) systems.
Problem-solving skills and experience with root cause analysis methodologies.
Experience in Microsoft Office applications, including Excel, Word, and PowerPoint.
Work collaboratively in a team-based environment.

Responsibilities

Ensure compliance with GSK safety, quality (GMP - Good Manufacturing Practice) and operational standards; participate in and enforce safety guidelines and procedures.
Lead and support investigations into process deviations, perform troubleshooting, identify root causes, and implement corrective and preventive actions (CAPAs) to prevent recurrence.
Support manufacturing operations and new product introductions by providing technical expertise and collaborating with cross-functional teams.
Drive continuous improvement initiatives (Kaizen, Value Stream activities): assess processes, suggest and implement method/equipment/layout improvements, and participate in related projects.
Author, review, revise and approve GMP documentation including Standard Operating Procedures (SOPs), batch records and operational readiness documents; ensure timely assignment and maintenance of compliance records for the Maintenance Department.
Provide technical support for change controls, gap and risk assessments, and other quality/technical governance activities; author and coordinate required documentation.
Monitor production/process performance, identify opportunities to improve efficiency and reduce waste, and support implementation of solutions.
Provide training and technical guidance to operations teams to ensure consistent, high-quality manufacturing practices.
Manage procurement and vendor interactions: assist in sourcing, ordering, tracking and liaising with vendors to ensure timely delivery of supplies, equipment and services; resolve discrepancies.
Maintain accurate departmental records and data: enter and update purchase orders, inventory, invoices, compliance documents and other administrative records in relevant systems (e.g., ERP, Excel); keep organized digital and physical records for audits.
Prepare, review and distribute administrative documentation (purchase requisitions, vendor correspondence, internal reports) ensuring completeness, timeliness and compliance with company policies.
Interface with users, peers and management to align local and corporate standards and ensure appropriate input and integration across teams.