Flexible & Integrated Technical Services, LLC

Manufacturing Document Clerk

Pharmaceutical - Carolina, Puerto Rico, Puerto Rico - Contracted

For Documentation services in the Quality area

WHAT MAKES YOU A FIT: 

The Technical Part:

  • Bachelor’s Degree and previous experience in compliance and/or document control activities within the Pharmaceutical or Medical Devices industry. 
  • Excellent reading, writing, and speaking skills in Spanish and English.
  • Shift: 24/7 manufacturing operations support, and according to business needs.
    • 8-hour shifts. 
  • Experience in:
    • Electronic Document Management Systems (QualityDos, Veeva, etc.)
    • GMP Records Management (Controlled printing, scanning, and archival processes)
    • Organization, Retention, Accessibility, and Confidentiality

The Personality Part:    

  • Our Next Piece is someone who treats everyone they meet like family, especially our resources, clients and team members. In other words, being a customer service pro is one your (many) talents. Being the Piece means you're full of bright ideas and eager to innovate, always bringing top-quality results to the table. Are you ready to take on this new challenge?

AS A PIECE OF FITS, YOU WILL: (The day-to-day on the job)​​​​​​​

  • Oversee the receipt, review, organization, and maintenance of company records and documents, ensuring proper classification and secure storage in accordance with the site’s retention policies.
  • Develop, implement, and maintain efficient digital and physical filing systems.
  • Ensure all files are systematically organized, easily retrievable, and aligned with company and industry standards for good documentation practices.
  • Examine documents for accuracy and completeness, making necessary corrections and updates to ensure data integrity and regulatory compliance.
  • Update and preserve records and databases to facilitate operational processes and fulfill legal and regulatory obligations. Regularly audit files to ensure ongoing compliance.
  • Respond promptly and professionally to documentation-related inquiries and requests from internal and external stakeholders, maintaining strict confidentiality and adherence to company requirements.
  • Identify opportunities to enhance document control processes and implement best practices to streamline workflow and support continuous improvement initiatives.
  • Support compliance with GMP and Good Documentation Practices (GDP).
  • Ensure records are audit-ready for regulatory inspections.
  • Support control activities for documents within approved electronic document management systems.
  • Effective communication, positive interpersonal behaviors, and productive working relationships across teams.

WHO WE ARE:

We are a Service Provider company different from the rest. We pride ourselves in how we treat the most important piece of our company's puzzle: you! We integrate Engineering, Construction, Maintenance, Utilities and Specialized Technical services across the Island (and in the US as well!). Our company is flexible, family-oriented and focused on our resources' well-being, while providing our Pharmaceutical, Medical Device and Manufacturing industry clients with top-notch quality talent. We're FITS! 

Are you the Next Piece?

Apply: Manufacturing Document Clerk
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