Position: Manufacturing Compliance Specialist

Location: King of Prussia (Onsite)

Company: SK Pharmteco

The Manufacturing Compliance Specialist will be responsible for helping to drive the on-time-delivery through batch closeout for all manufacturing programs, audit response and audit readiness, and other manufacturing compliance activities. We’re looking for an individual who is a motivated self-starter and eager to contribute to building a manufacturing operation unparalleled in its capabilities and expertise. The individual should also have a willingness and aptitude for adoption of new technologies, an ability to build relationships and work effectively in a cross-functional team, and commitment to the highest safety and quality standards.

Responsibilities:

• Support manufacturing Quality Audits (internal/external) and Regulatory Inspections.
• Support new equipment on-boarding through review and approval of IQ/QQ/PQ documents, as required.
• Support GMP Material Updates (Material Specifications, SCAR) as needed.
• Drive on-time batch release.
• Participate facility readiness activities, as required (i.e., Safety, GEMBA walks).
• Participate/Lead/Identify continuous improvements.
• Timely escalation of issues that put batch release and manufacturing readiness timelines at risk.
• Review Executed Documents as needed.
• Communicate roadblocks and challenges in a timely manner which impact task and timely delivery of investigation.
• Review/Update Executed Document Review tracker and drive target due dates.
• Track the closeout of production order tasks.
• Information gathering for deviations and observational trends.
• Coach/Mentor manufacturing personnel on industry best practices and drive right first-time mindset and execution.
• Support in maintaining the cGMP status of the manufacturing facility to always ensure inspection readiness.
• Support technical writing of departmental SOPs, WI’s, FORMS and quality records, as required.
• Support tracking and trending of manufacturing quality KPI’s.
• Support self-inspections of manufacturing areas during active and non-active processing.
• Support manufacturing training compliance and KPIs.
• Track quarterly cycle counts and ensure issues are reconciled.

Requirements:

• Bachelor’s degree in biological science(s) field is preferred.
• Minimum 3 years of experience in GMP biologic Manufacturing.
• 1-2 years of Quality Assurance is preferred.
• Strong technical writing skills.
• Outstanding communication skills (verbal and written).
• Excellent computer and word processing skills including Microsoft Excel, PowerPoint, and Word.
• Strong knowledge of cGMP regulations.
• Working knowledge of GMP systems for: inventory management, asset management, sample management, quality management, and learning management.
• Ability to work well independently, as part of a team, and establish working interdepartmental relationships.
• Exhibits extreme attention to detail, accuracy in work, and integrity of character.
• Self-starter who shows eagerness to learn and problem-solve.
• Innovative and efficient when solving problems with a strong focus on continuous improvement.

Physical Requirements:

• Must have the ability to gown in a clean room environment and apply required PPE for some period to perform audits, GEMBA walks, and tours.
• Ability to sit for periods of time viewing a computer workstation.