Quality Control Specialist

4 weeks ago


Reston, Virginia, United States Planet Pharma Full time
Job Title: Quality Control Technician

Job Summary:

We are seeking a highly skilled Quality Control Technician to join our team at Planet Pharma. The successful candidate will be responsible for ensuring the quality and reliability of our equipment and processes.

Key Responsibilities:

  • Execute routine work orders and interact with end customers and vendors to ensure reliable QC equipment support.
  • Own change controls for new and/or replacing of QC equipment.
  • Manage the procurement of new QC equipment and lead cross-functional stakeholders to identify end-user requirements.
  • Support inspection readiness activities across Quality Control and site audits and inspections.
  • Monitor and trouble shoot analytical benchtop equipment.
  • Lead projects and project planning responsibilities to ensure on time implementation of analytical instruments.
  • Complete all assigned tasks on time, in collaboration with key stakeholders.
  • Provide oversight of vendor PMs.
  • Create new assets and PM scheduling in Maximo.

Requirements:

  • Experience in writing and managing Change Controls.
  • Experience in executing general, preventative, and corrective maintenance in Maximo system.
  • Validation experience (Lab equipment, computer related systems).
  • Focus on data integrity and cGMP practices.
  • Project management.
  • Proficiency in Excel, Word, and PowerPoint, Outlook, and Project.
  • Strong interpersonal skills.
  • Excellent written and verbal communication skills.
  • Experience with analytical laboratory testing.

Preferred Qualifications:

  • GMP and GDP experience in a laboratory setting.
  • Proficient in Trackwise, Maximo, CDOCS.
  • Experienced in Quality systems, including Change Control, Deviations, CAPA.
  • Experienced in Quality processes, including validation and data integrity.
  • Proficient in problem solving and LEAN principles.

Education:

  • Bachelor's degree and 0-2 years of Quality/ Operations Experience.
  • Associate's degree and 3+ years of Quality/ Operations Experience.
  • High school diploma/GED and 4+ years of Quality/ Operations Experience.


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