Manufacturing Operations Specialist

1 day ago


Philadelphia, Pennsylvania, United States Planet Pharma Full time
Job Summary

We are seeking a highly skilled Manufacturing Specialist to join our team at Planet Pharma. This role will be responsible for supporting the manufacturing operations team in ensuring the efficient and effective production of high-quality biopharmaceutical products.

Key Responsibilities
  • Document Control: Develop and maintain accurate and up-to-date documentation, including SOPs, batch records, and deviation reports.
  • Root Cause Analysis: Lead investigations into nonconformances and deviations, and implement corrective actions to prevent recurrence.
  • Change Control: Manage changes to manufacturing processes and equipment, ensuring compliance with regulatory requirements.
  • Team Collaboration: Work closely with cross-functional teams to ensure seamless communication and coordination.
  • Quality Assurance: Ensure adherence to Good Manufacturing Practices (GMP) and Standard Operating Procedures (SOPs), including Good Documentation Practices (GDP).
  • Problem-Solving: Troubleshoot issues and prioritize workload to resolve moderately complex problems.
  • Communication: Effectively communicate with team members, management, and external stakeholders to ensure timely completion of tasks and projects.
Requirements
  • Education: Bachelor's degree in biology, biochemistry, bioengineering, or related field.
  • Experience: Minimum 2 years of experience in biopharmaceutical manufacturing operations.
  • Skills: Strong technical knowledge of aseptic processing, leadership skills, and ability to work in a fast-paced environment.
  • Physical Demands: Ability to work in a cleanroom setting, wear personal protective equipment, and lift up to 45 pounds.
Work Environment

This role will work in a combination of office and manufacturing cleanroom settings, with potential exposure to noise, equipment hazards, and strong odors.



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