Manufacturing Documentation Specialist

6 days ago


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

Job Title: Manufacturing Documentation Specialist

Job Summary: We are seeking a highly skilled Manufacturing Documentation Specialist to join our team at Planet Pharma. The successful candidate will be responsible for supporting the development and maintenance of high-quality documentation for our manufacturing operations.

Key Responsibilities:

  • Support the creation and revision of SOPs, Batch Records, Deviations, CAPAs, and other documentation related to manufacturing operations.
  • Lead teams investigating minor, major, and critical non-conformances and deviations, including gathering information through structured root cause analysis.
  • Own and manage change controls associated with manufacturing areas and equipment.
  • Participate in technology transfer, conference calls, and sharing of technical information.
  • Coordinate front-end document requests with supporting departments.
  • Ensure that Deviations and CAPAs are addressed in a timely manner, and that Batch Records revisions are reviewed and approved in a timely manner.
  • Continuously seek and support new approaches, practices, and processes to improve the efficiency and efficacy of document review and revision.
  • Adhere to Good Manufacturing Practices (GMP) and Standard Operating Procedures (SOPs), including Good Documentation Practices (GDP).

Requirements:

  • Minimum bachelor's degree in biology, biochemistry, bioengineering, or related technical field, or equivalent industry experience.
  • Minimum of 2 years of experience in biopharmaceutical-based GMP manufacturing operations.
  • Demonstrated strong technical knowledge of aseptic processing in cleanroom environments.
  • Ability to build relationships quickly and credibly, with excellent communication and organizational skills.
  • Proactive, results-oriented, self-starter with demonstrated strong leadership skills and experience in a complex manufacturing environment.
  • Ability to deal with ambiguity and manage constant change.
  • Quality mindset, familiar with 21 CFR Part 11 and standard GxP best practices and FDA regulations.
  • Excellent presentation skills, both written and verbal.
  • Understanding of quality standards and requirements as documented.
  • Strong computer skills, problem-solving, and attention to detail.
  • Familiarity with data and sample management required (LIMS/MES).

Work Environment:

  • This position will work in both an office and a manufacturing cleanroom setting.
  • When in the lab, must be able to work in a cleanroom setting with various chemical/biochemical exposures, including latex and bleach.
  • Able to work in a cleanroom with biohazards, human blood components, and chemicals.
  • Potential exposure to noise and equipment hazards and strong odors.

Physical Demands:

  • Must be able to wear appropriate clean room attire and all Personal Protective Equipment (PPE), i.e. scrubs, gowning coverall, masks, gloves, etc.
  • Able to stand and/or walk 90% (and sit 10%) which may include climbing ladders or steps.
  • Able to crouch, bend, twist, reach, and perform activities with repetitive motions.
  • Must be able to lift and carry objects weighing 45 pounds.

Mental Demands:

  • Clear and conceptual thinking ability; excellent judgment, troubleshooting, problem-solving, analysis, and discretion.
  • Ability to handle work-related stress; ability to handle multiple priorities simultaneously; and ability to meet deadlines.

Travel:

  • May require up to 10% travel, based on business need.

Salary and Benefits:

  • Salary target ~$75-85K base, 10% bonus target, will have bonus and long term incentives (stock).

How to Apply:

Please submit your application, including your resume and cover letter, to [insert contact information].



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