Validation & Engineering Group, Inc.

MV02-012726 Test Method Transfer - QC Lab

Validation & Engineering Group, Inc.  •  Duluth, GA (Onsite)  •  2 months ago
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Job Description

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
  • 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:

  • Bachelor's 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.

About Validation & Engineering Group, Inc.

Validation & Engineering Group, Proudly serving our clients since 1997.

Our Mission states in part: "provide our clients with the best resources to meet their needs". In our search for the best talent, we are inclusive and do not discriminate. V&EG is proud to be an equal opportunity workplace and is an affirmative action employer.

Validation & Engineering Group provides world-class service and expertise to the pharmaceutical, medical device and biotechnology industries. We offer our clients: Validation, Control System Solutions, Instrumentation, Training, Equipment Rentals, and Regulatory Compliance Services to ensure adherence to Federal and European regulatory agencies. Our group had serve in solid dosages, liquids, creams, lyophilizers, and parenteral dosage.

Our agility in responding to our clients’ needs, access to the best pool of talent, and the combined experience and technical expertise of our resources make Validation & Engineering Group a leader in the pharmaceutical, medical devices, and biotechnology industries.

At Validation & Engineering Group we provide professional expertise in the areas of:

•Audit and Assessment

•Automated Process Control System Qualification

•Equipment and Facilities Qualification

•Facilities Start-Up and Commissioning

•GAP Analysis

•Information Systems Computer Validation

•Packaging and Process Analysis

•Process & Cleaning Validation

•Project Management

•Quality Systems

•Risk Based Approach

•Regulatory Compliance

•Standard Operating and Maintenance Procedures

•Training

•Utilities Support and Qualification

In addition we offer Equipment Rentals and training to your workforce such as: Temperature & Relative Humidity, Electrical, Process, Environmental, and. Analytical.

Our Offices:

Puerto Rico:

Centro Internacional de Mercadeo I 100 Carr. 165 Ste 703, Guaynabo, 00968 Puerto Rico

Phone: (787) 622-0996

United States:

2180 Satellite Blvd, Suite 400Duluth, Georgia 30097 United States

Phone: (770) 403-5802

Industry
Architecture & Engineering
Company Size
51-200 employees
Headquarters
Guaynabo, PR
Year Founded
1997
Website
veg-group.com
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