Quality, Lead Investigator

For Compliance services in the Quality area.

 WHAT MAKES YOU A FIT:  

The Technical Part:

• Bachelor’s Degree in Chemical Engineering, Biology, or Microbiology Science & five (5) years of experience in the Pharmaceutical Manufacturing industry. 
• Bilingual (English & Spanish)
• Experience in:
  • GMP, FDA, EU regulations.
  • Parenteral Manufacturing.
  • Technical Writing. 
  • Regulatory Investigation reports, CAPA, Non-conformances, and internal audits.
  • Computer Systems & Track-wise.

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 of 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 Be The Piece?

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

• Acknowledge conduct and/or approve investigations for Customer Complaints, External Complaints, approve Regulatory CAPA, Vendor Certification, Quality Agreements, APR for Finished Product and Systems, and site licenses.
• Support the readiness of the facility for Regulatory Inspection.
• Assist the Associate Director of Compliance and auditing during regulatory agencies' inspections, such as FDA / EMEA, and/or during internal company audits.
• Conduct internal/external audits following the annual site plan, with respective reports and action items from areas impacted during the audit.
• Ensure the site has an internal audit program and that all system audits are conducted at a specified frequency.
• Create, review, approve, and track corrective actions related to internal and external audits and prepare, submit, and discuss reports of assigned Quality Systems status for trending and evaluation to the site management.
• Provide site GMP training based on annual requirements and support and training to other departments to ensure quality compliance as needed.
• Generate, review, and implement departmental procedures and forms to assure compliance with current practices or GMP trends.
• Ensure that Quality and Compliance are implemented in laboratory and operational areas and maintain them according to regulatory agencies' expectations.
• Manage document, including record retention program, compliance and custody of SOPs, review/approval/issuance of master documentation related to operational areas, and evaluate compliance of all procedures (SOPs) and master documentation with regulations and company policies.
• Provide guidance and support on the transfer and introduction of new products and processes to the site to maintain quality and compliance.

WHO WE ARE:

We are a Service Provider company different from the rest. We pride ourselves on 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?