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Manufacturing Operations Specialist

1 month 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. The successful candidate will be responsible for supporting documentation, leading teams investigating nonconformances, and managing change controls.

Key Responsibilities
  • Documentation Support
    • Assist in drafting and approving SOPs, Batch Records, Deviations, CAPAs, and other documentation.
    • Perform basic revisions to ensure accuracy and compliance.
  • Nonconformance Investigations
    • Lead teams in investigating minor, major, and critical nonconformances and deviations.
    • Draft and revise deviation reports as needed.
  • Change Control Management
    • Own and manage change controls associated with manufacturing areas and equipment.
  • Team Collaboration
    • Participate in technology transfer, conference calls, and sharing of technical information.
    • Coordinate front-end document requests with supporting departments.
  • Quality Assurance
    • Ensure that Deviations and CAPAs are addressed in a timely manner.
    • Review and approve Batch Records revisions in a timely manner.
  • Continuous Improvement
    • Seek and support new approaches, practices, and processes to improve efficiency and efficacy.
  • Regulatory Compliance
    • Adhere to Good Manufacturing Practices (GMP) and Standard Operating Procedures (SOPs).
    • Complete recording of data to comply with regulatory requirements.
Requirements
  • Education
    • Minimum bachelor's degree in biology, biochemistry, bioengineering, or related technical field.
  • Experience
    • Minimum of 2 years of experience in biopharmaceutical based GMP manufacturing operations.
  • Skills
    • Demonstrated strong technical knowledge of aseptic processing in cleanroom environments.
    • Ability to build relationships quickly and credibly.
    • Proactive, results-oriented, self-starter with strong leadership skills.
    • Ability to deal with ambiguity and manage constant change.
    • Quality mindset, familiar with 21 CFR Part 11 and standard GxP best practices.
    • Excellent presentation skills, both written and verbal.
    • Strong computer skills, problem-solving, and attention to detail.
What We Offer
  • Regular work week hours (1st shift M-F)
  • Opportunity to work in a team environment and independently as required
  • Competitive salary and benefits package