Manufacturing Specialist

Role Summary

Location: USA - Pennsylvania - Marietta. 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). As a Manufacturing Specialist, you will help ensure 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.

Responsibilities

• Ensure compliance with GMP safety, quality 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 (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.

Qualifications

• Required: 1+ years of experience in a regulated manufacturing environment, such as pharmaceutical or biopharma.
• Required: Experience of Good Manufacturing Practices (GMP) and quality systems, including deviation investigation, change management, and corrective actions.
• Required: Problem-solving skills and experience with root cause analysis methodologies.
• Required: Experience in Microsoft Office applications, including Excel, Word, and PowerPoint.
• Required: Work collaboratively in a team-based environment.
• Preferred: 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.
• Preferred: Experience of cGMPs, and to quickly grasp and apply site policies and procedures and relate them to project scope.
• Preferred: Interpersonal skills.
• Preferred: Experience to function within team-based organization.
• Preferred: Analyse information, problems, situations, practices or procedures; define and identify the concerns or factors.
• Preferred: Experience managing projects in order to achieve deliverables and adhere to timelines and budgets.
• Preferred: Prioritize and decide appropriate course of actions and implementing decisions.
• Preferred: Communicate both verbally and in writing with all levels of the organization, as well as the skills to communicate site operations to outside agencies.
• Preferred: Communicate complex ideas and concepts in a clear, compelling way.
• Preferred: Experience with process improvement methodologies, such as Lean or Six Sigma.
• Preferred: Experience with production equipment systems and process diagrams.
• Preferred: Experience with new product introduction or technology transfer.
• Preferred: Experience managing multiple priorities and meet deadlines.
• Preferred: Experience with Enterprise Resource Planning (ERP) systems.
• Preferred: Experience in Microsoft Office applications, including Excel, Word, and PowerPoint.
• Preferred: Work collaboratively in a team-based environment.

Education

• Bachelor’s degree in a scientific discipline