ProQuality Network

Documentation and Logistics Specialist (FDA Regulated Industry)

Posted 30+ days ago

Job summary

  • Job post source

    This job is from a recruiting firm hiring for a separate company.

  • Job overview

    The Documentation and Logistics Specialist role supports a start-up manufacturing facility in the FDA-regulated life sciences industry, ensuring proper management of documentation and logistics to maintain compliance and operational efficiency.

  • Responsibilities and impact

    The specialist manages GMP documentation control, coordinates workflows across departments, tracks batch records and SOPs, supports document lifecycle processes, assists with inventory and material logistics, ensures compliance with regulatory standards, prepares documentation reports, and supports audits and inspections.

  • Experience and skills

    Requires a bachelor's degree in a scientific or technical field and at least 5 years of experience in documentation control or logistics within a GMP/FDA-regulated manufacturing environment; preferred experience includes facility startup projects and familiarity with electronic documentation and ERP systems.

  • Work environment and culture

    The role is 100% onsite in North Carolina, emphasizing a fast-paced, compliance-driven environment suitable for detail-oriented and organized professionals.

  • Company information

    The client is a global leader in the life sciences industry with a new manufacturing facility startup in North Carolina.

  • Job location and travel

    The position is located onsite in North Carolina, USA, with preference for local candidates who are U.S. Citizens or Permanent Residents.

  • Application process

    Candidates are encouraged to apply through the job description link and submit an updated resume for consideration.

  • Unique job features

    This contract role involves supporting a start-up manufacturing facility in an FDA-regulated environment, offering experience in commissioning and qualification documentation and cross-functional collaboration.

Company overview

ProQuality Network is a pharmaceutical company known for its significant role in regulatory compliance within the industry. Based in Somerset, NJ, the company employs specialists who ensure adherence to regulatory standards, which is crucial for maintaining its reputation and operational integrity. The company is led by President Elizabeth Plaza and has a presence in Puerto Rico, with offices located in the Sardinera Office Center in Dorado. ProQuality Network's expertise in compliance is a key component of its business model, helping it to navigate complex regulatory environments effectively.

How to land this job

  • Position your resume to highlight your extensive experience managing GMP documentation and logistics within FDA-regulated environments, emphasizing your ability to support manufacturing startups and facility commissioning activities.

  • Focus on showcasing your skills in document control, revision management, and cross-department coordination, particularly with Quality Assurance, Validation, and Supply Chain teams, as these are critical for the role.

  • Apply through multiple platforms such as ProQuality Network’s corporate career page and LinkedIn to maximize your application's exposure and increase your chances of being noticed.

  • Connect with current ProQuality Network employees or those in the life sciences division on LinkedIn; break the ice by referencing your shared interest in FDA compliance or asking about challenges in managing documentation workflows during facility startups.

  • Optimize your resume for ATS by incorporating keywords like 'GMP documentation,' 'FDA-regulated,' 'document control,' 'logistics,' 'cGMP compliance,' and names of electronic documentation systems like 'Veeva' or 'MasterControl' to ensure it passes initial automated screenings.

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