The Role
Lead manufacturing quality investigations for sterile and non-sterile operations, ensuring timely closure of quality events, NTRs, and NOEs. Coordinate investigation information, develop recurrence-prevention actions, evaluate QE and CAPA trends, support regulatory submissions and inspections, and contribute to site initiatives. The role requires scientific and compliance expertise, statistical data analysis, technical writing, and bilingual Spanish-English communication.
Summary Generated by Built In
We are seeking an Investigation Lead to provide operational and scientific expertise,
together with compliance knowledge, in support of manufacturing sterile and non-sterile operations. The resource will execute manufacturing
investigations (Quality Events, or QEs) and facilitate the collection and
coordination of information required to support those investigations.
Responsibilities
- Ensure that all QEs, NTRs, and NOEs are
completed and closed within the established timeframe, using the appropriate
tools to prevent recurrence.
- Review and provide input to regulatory
submissions applicable to the area of responsibility.
- Lead QE and CAPA trend evaluations.
- Participate in regulatory inspections when
necessary.
- Support site initiatives and other assignments
based on business needs.
Requirements
- Bachelor's degree in Science, Pharmacy, and/or
Engineering.
- Five (5) years of experience in a parenteral
manufacturing facility.
- At least one (1) year of experience in the investigation process.
- Strong technical writing and presentation
skills.
- Ability to interpret and analyze statistical
data.
- Knowledge of cGMPs, OSHA, EPA, and other
regulatory standards.
- Proficiency with Microsoft Word, Excel, and
PowerPoint.
- Excellent interpersonal skills and a
teamwork-oriented approach.
- Excellent written and verbal communication
skills in Spanish and English.
Skills Required
- Bachelor's degree in Science, Pharmacy, and/or Engineering
- Five years of experience in a parenteral manufacturing facility
- At least one year of experience in the investigation process
- Strong technical writing and presentation skills
- Ability to interpret and analyze statistical data
- Knowledge of cGMPs, OSHA, EPA, and other regulatory standards
- Proficiency with Microsoft Word, Excel, and PowerPoint
- Excellent interpersonal skills and a teamwork-oriented approach
- Excellent written and verbal communication skills in Spanish and English
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The Company
What We Do
QRC Group specializes in providing expert consulting services in regulatory compliance, quality management, and risk management for the pharmaceuticals, medical devices, biotechnology, and other regulated industries, delivering comprehensive project management and validation solutions.
