Compliance Specialist, Manufacturing

1 month ago

king of prussia, United States SK pharmteco Full time

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.

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