Manufacturing Documentation Specialist

3 days ago


Philadelphia, Pennsylvania, United States Planet Pharma Full time
Job Title: Manufacturing Documentation Specialist

About the Role:

We are seeking a highly skilled Manufacturing Documentation Specialist to join our team at Planet Pharma. As a key member of our manufacturing operations team, you will be responsible for ensuring the accuracy and completeness of documentation related to our biopharmaceutical manufacturing processes.

Key Responsibilities:

  • Support the development and maintenance of Standard Operating Procedures (SOPs), Batch Records, and other manufacturing-related documents.
  • Lead investigations into deviations and non-conformances, and ensure timely resolution and documentation.
  • Manage change controls and procedural updates to ensure compliance with Good Manufacturing Practices (GMP) and regulatory requirements.
  • Collaborate with cross-functional teams to ensure seamless execution of manufacturing processes and documentation.
  • Ensure accurate and complete documentation of manufacturing activities, including data collection and record-keeping.

Requirements:

  • Minimum 2 years of experience in biopharmaceutical manufacturing operations, with a focus on documentation and quality assurance.
  • Strong knowledge of GMP regulations and industry standards.
  • Excellent communication and interpersonal skills, with the ability to work effectively in a team environment.
  • Ability to analyze complex data and identify areas for improvement.
  • Proficiency in Microsoft Office and other relevant software applications.

Working Conditions:

  • This role will work in a cleanroom environment, with exposure to biohazards, human blood components, and chemicals.
  • Able to work in a fast-paced environment with multiple priorities and deadlines.

What We Offer:

  • Competitive salary and bonus structure.
  • Opportunities for professional growth and development.
  • A dynamic and collaborative work environment.

How to Apply:

Interested candidates should submit their resume and a cover letter outlining their qualifications and experience.



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