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Operations Process Compliance Specialist

FITS LLC Humacao, PR

  • Expired: July 03, 2020. Applications are no longer accepted.

Job Description For Process Compliance services in the Quality area WHAT MAKES YOU A FIT: The Technical Part: • Bachelor’s degree in Science, pharmacy and/or Engineering & five (5) years of exposure in a Oral Solid Dosage Manufacturing facility • Experience in: - Operational and scientific investigation - Computer applications (Microsoft Word, Excel, Power Point) - SOPs and CAPA’s - Manufacturing documentation The Personality Part: • If you have a commitment to serving customers with high-quality research and products, to embracing a diverse work culture, and even to the environment, you might just be what we’re looking for! AS A PIECE OF FITS, YOU WILL: (The day-to-day on the job) • Execute and ensure that all Quality Events (QEs) and CAPAs are completed / closed within the established timeframe, utilizing the right tools to measure effectiveness to prevent reoccurrence. • Review and provide input to regulatory submissions applicable to area of responsibility. • Interact with regulatory compliance agencies with respect to Quality Events. • Provide written responses to regulatory observations as well as ensuring implementation of commitments. • Conduct systematic QEs evaluations to minimize risk of reoccurrence and; ensures the effectiveness of CAPA’s. • Support establishment of process monitoring parameters and control limits • Manage Quality Council metrics (i.e. QE’s and CAPA’s) and share trends and gaps with management. • Evaluate and revise manufacturing documentation resulting from a compliance gap and; may assist in providing training related to the revised manufacturing documentation. • Participates and represents the manufacturing department in all process compliance initiatives including regulatory inspections. • Revise and update SOPs to ensure robustness in our operations to reduce/eliminate potential investigations BEING A FITS PIECE COMES WITH PERKS: • One of these is the excellent, unmatched, never-before-seen customer service of our team (trust us, you’ll be amazed). However, that’s not all we have to offer.

Talk with us to find out! 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? Powered by JazzHR y6sJJoIiFn



Humacao, PR
00791 USA



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