Validation & Engineering Group Inc. (V&EG) is a leading services supplier who provides solutions for the Pharmaceutical Biotechnology Chemical Food and Medical Devices industries in the following areas: Laboratory Compliance Computer Engineering Project Management Validation and other services.
We are seeking a talented dedicated individual committed to work under the highest ethics standards for the following position:
- Test Method Transfer - QC Lab Support
Summary:
- Lead and coordinate the transfer of analytical test methods from current to the receiving QC laboratory.
- Review and assess method documentation validation reports and transfer protocols for completeness and compliance.
- Prepare execute and document method transfer protocols.
- Perform hands-on laboratory testing to demonstrate method reproducibility and equivalency between sending and receiving sites.
- Train receiving laboratory analysts.
- Evaluate and investigate any discrepancies deviations or out-of-specification results during transfer activities.
- Collaborate with method development quality assurance manufacturing and regulatory teams.
- Support troubleshooting method optimization and lifecycle management after successful transfer.
Qualifications:
- Bachelors Degree in Science or Engineering.
- Minimum of 3 years of experience in direct pharmaceutical medical device or biotechnology industries.
- Must be fully bilingual (English / Spanish) with excellent oral skills.
- Strong knowledge in cGxP and regulatory guidance and compliance.
- Available to work extended hours possibility of weekends and holidays.
Validation & Engineering Group Inc. (V&EG) is a leading services supplier who provides solutions for the Pharmaceutical Biotechnology Chemical Food and Medical Devices industries in the following areas: Laboratory Compliance Computer Engineering Project Management Validation and other services.We ar...
Validation & Engineering Group Inc. (V&EG) is a leading services supplier who provides solutions for the Pharmaceutical Biotechnology Chemical Food and Medical Devices industries in the following areas: Laboratory Compliance Computer Engineering Project Management Validation and other services.
We are seeking a talented dedicated individual committed to work under the highest ethics standards for the following position:
- Test Method Transfer - QC Lab Support
Summary:
- Lead and coordinate the transfer of analytical test methods from current to the receiving QC laboratory.
- Review and assess method documentation validation reports and transfer protocols for completeness and compliance.
- Prepare execute and document method transfer protocols.
- Perform hands-on laboratory testing to demonstrate method reproducibility and equivalency between sending and receiving sites.
- Train receiving laboratory analysts.
- Evaluate and investigate any discrepancies deviations or out-of-specification results during transfer activities.
- Collaborate with method development quality assurance manufacturing and regulatory teams.
- Support troubleshooting method optimization and lifecycle management after successful transfer.
Qualifications:
- Bachelors Degree in Science or Engineering.
- Minimum of 3 years of experience in direct pharmaceutical medical device or biotechnology industries.
- Must be fully bilingual (English / Spanish) with excellent oral skills.
- Strong knowledge in cGxP and regulatory guidance and compliance.
- Available to work extended hours possibility of weekends and holidays.
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