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: CGMPs, OSHA, EPA, and other regulatory standards. Parenteral Manufacturing. Technical Writing. Regulatory Investigation reports, CAPA, Non-conformances, and internal audits. Computer Systems & Track-wise. The Personality Part: We are looking for someone who treats everyone they meet like family—our resources, clients, and team members. Customer service skills are essential. The ideal candidate is full of bright ideas, eager to innovate, and committed to delivering top-quality results. Are you ready to Be The Piece? AS A PIECE OF FITS, YOU WILL: (The day-to-day on the job) Ensure all QEs, NTRs, NOEs, and CAPAs are completed/closed within the established timeframe, using the appropriate tools to prevent reoccurrence. Review and provide input to regulatory submissions relevant to your area of responsibility. Lead trend evaluation of QEs and CAPAs. Participate in new product introduction processes to determine documentation, materials, training, and equipment modification requirements. Support the establishment of process monitoring parameters and control limits. Assist in the assessment of deviations and process monitoring data. Monitor and evaluate parameters in ongoing processes to optimize process times, productivity, equipment performance, yields, and quality. Provide technical assistance to identify, recommend, and implement process and equipment modifications to improve performance, reduce costs, and ensure cGMP compliance. Write, evaluate, and revise manufacturing documentation (e.g., SOPs, MBRs) and assist in training on scientific or technical aspects. Assist with the development and execution of validation protocols and reports. Participate in regulatory inspections when necessary. Support area managers and supervisors in solving technical production problems (e.g., troubleshooting, yield, cycle time, quality, productivity). Offer alternatives and recommendations to improve processes and equipment. Participate in environmental regulatory and compliance permits and process safety hazard evaluations. Promote and model BMS Core Behaviors, fostering teamwork. Support site initiatives and other assignments as needed. WHO WE ARE: We are a service provider company that values its people. We integrate Engineering, Construction, Maintenance, Utilities, and Technical services across the Island and in the US. Our company is flexible, family-oriented, and focused on resource well-being, providing top-tier talent to our Pharmaceutical, Medical Device, and Manufacturing clients. We're FITS! Are you the Next Piece? #J-18808-Ljbffr