Quality, Lead Investigator
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Job Location:
Monthly Salary:
Posted on:
30+ days ago
Vacancies:
1 Vacancy
Job Summary
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)
- Experience in:
- Manufacturing Investigations
- Change Control
- Developing implementing and tracking CAPAs.
- Procedures Development and Revisions.
- Process Validations
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)
- Ensures that all QEs NTRs NOESand CAPAsare completed/closedwithin the established timeframe utilizing the right tools to prevent reoccurrence.
- Reviews and provides input to regulatory submissions applicable to the area of responsibility.
- Leads QEs and CAPAs trend evaluation.
- Participates in the new product introduction process to determine requirements for documentation materials training and equipment modifications.
- Supports the establishment of process monitoring parameters and control limits.
- Supports the assessment of deviations and process monitoring data.
- Monitors and evaluates parameters in existing (on-going) processes to optimize process times/productivity equipment performance yields and quality.
- Provides technical assistance to identify recommend and implement process and equipment modifications to improve process performance; to identify and assist in the implementation of cost reduction projects and ensurethe manufacturing area complies.
- Write evaluate and revise the required manufacturing documentation (i.e. SOPs MBRs etc.) and may assist in providing training on scientific or technical aspects of the processes
- Assists with the generation and execution of validation protocols and reports.
- Participates in regulatory inspection when necessary
- Assists the area managers and supervisory personnel to solve any production technical problem (i.e. Process/equipmenttroubleshooting yield cycle time quality and productivity).
- Provides alternatives and recommendations to improve and maximize processes and equipment.
- Participates in Environmental Regulatory and Compliance Permits and Process Safety Hazards evaluation.
- Promotes and models the clients Core Behaviors facilitating teamwork.
- Supports all site Initiatives and any other assignments based on business needs.
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
Key Skills
- Epidemiology
- Public Health
- Bank Secrecy Act
- Bioinformatics
- Fraud
- Genetics
- Interviewing
- Law Enforcement
- Qualitative Research Interviewing
- Research Experience
- Next Generation Sequencing
- Writing Skills
