Product Disposition Release Specialist
FITS LLC Humacao, PR
- Expired: over a month ago. Applications are no longer accepted.
For Disposition services in the Quality area
WHAT MAKES YOU A FIT:
The Technical Part:
- Bachelor’s degree in Microbiology, Chemistry, General Science, Engineering or Pharmacy & five (5) years of exposure in the Pharmaceutical industry.
- Bilingual (English & Spanish)
- 1st shift - must have availability to work OT and on weekends if needed.
- Experience in:
- Quality and Manufacturing (5 years).
- Change Control, Investigations and CAPA’s.
- Relevant governmental regulations, cGMPs SOP’s and guidelines.
- SAP and LIMS, process disposition.
The Personality Part:
- If you have a commitment to serving customers with high-quality research and products, 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)
- Evaluate product deviations and open notice of event in the Trackwise system for any detected deviation or documentation error during the batch record evaluation process.
- Perform required Queries on SAP and Trackwise System to provide evidence of document closing at the disposition time.
- Assure all Quality Events, Change Controls, CAPA’s and/or any other required documentation related to the lots are completed and closed before release.
- Audit vendor certificates and receive reports for completeness and compliance with established requirements.
- Evaluate analytical results vs. established specifications and determine compliance, release material for use or provide an appropriate disposition for products.
- Evaluate lots test results against trending data to identify any irregular behavior of the lots.
- Maintain communication with the stability area of any released lot with a stability requirement.
- Coordinate priorities to assure timely release of materials and products.
- Prepare certificates of compliance (CoC) and certificate of analysis (CoA) for raw material and/or products for commercial release according to market requirements.
- Maintain communication with other sites and external customers related to lot disposition.
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?
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