Manager, Quality Assurance Scientist
Manager, Quality Assurance Scientist
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Job Description
For Compliance services in the Quality area.
WHAT MAKES YOU A FIT:
The Technical Part:
- Bachelors Degreein ChemicalEngineering Biology or Microbiology Science & five (5) years of experiencein the Pharmaceutical Manufacturing industry.
- Bilingual (English & Spanish)
- Shifts: 12-hournight shiftsandweekends.
- 5:00 PM - 5:00 AM
- Experience in:
- Quality Assurance & cGMP Compliance
- GMP Document Approval
- Investigation & Root Cause Analysis
- Cross-Functional Collaboration
The Personality Part:
- Our Next Piece is someone who treats everyone they meet like family especially our resources clients and team other words being a customer service pro is one of your (many) talents. Being the Piece means youre 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)
- Ensure all manufacturing and support area operations comply with domestic and international cGMP regulations and company policies. This includes leading audits and providing guidance to various departments to ensure adherence to quality standards.
- Lead the critical review and approval of a wide range of GMP documents including batch records SOPs protocols and validation reports. Evaluate documentation for compliance with data integrity and electronic systems requirements.
- Provide scientific and technical input for investigations.
- This involves identifying root causes evaluating product impact and ensuring that Corrective and Preventive Actions (CAPAs) are effective and aligned with identified gaps.
- Serve as a quality representative and subject matter expert on various site teams and projects.
- Provide technical guidance and coaching to manufacturing QC engineering and other support teams to maintain quality standards.
- Actively participate in risk analysis processes and perform trend analysis to identify opportunities for process and product quality improvements.
- Provide quality assurance support for new product transfers and participate in the review and approval of validation protocols Annual Product Reviews (APQR) and change control documentation.
- Assist management during internal and external regulatory inspections (e.g. FDA DEA).
- Manage audit observations and other quality records within the Quality Management System (QMS).
- Keep management informed of any quality issues that could impact product quality or the timely release of materials through regular written reports.
WHO WE ARE:
We are a Service Provider companydifferent from the rest. We pride ourselves onhow we treat the most important piece of our companys 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 industryclients with top-notch quality talent.Were FITS!
Are you the Next Piece
Required Experience:
Senior IC
Employment Type
Contract
