Validation Associate

Top Job

Located in Texarkana, TX

Position: Validation Associate
Location: Texarkana, TX
Industry: Pharmaceutical
Salary: $45,000

 

PURPOSE:
The Validation Associate is responsible for supporting validation of manufacturing and packaging processes, cleaning processes, and qualification of equipment. This person will also be responsible for the generation of Annual Product Reports. This person will also be responsible for facilitating internal deviation and investigation reports.

GENERAL DESCRIPTION:
The Validation Associate supports the procedures for validations in an FDA regulated environment.

 

JOB FUNCTIONS:

• Perform annual product reviews (APRs) of manufactured drug products.
• Draft validation protocols for process, cleaning, equipment, and computer systems as needed.
• Perform batch record review of manufactured product for release.
• Conduct special projects as directed by the Validation Manager.
• Revise and author SOPs as needed.
• Revise batch records as needed.
• Participate in the effective use of quality systems.
• Collaborate with QC labs on method validations and qualification of lab equipment
• Perform any additional projects/tasks assigned by Quality Manager.
• Participate in customer and regulatory inspections.
• Participate in employee training program.
• Perform all other job duties as assigned by Pharma Nobis management.

QUALIFICATIONS:

• Must be safety minded.
• Excellent organization and computer use skills (MS. Word, MS Excel).
• Must be able to follow instructions and procedures.
• Must be able to interpret analytical data.
• Must be scientific and safety minded.

EDUCATION REQUIREMENTS:

• A bachelor’s degree is strongly preferred with emphasis in Math, Engineering, Biology, Chemistry, or Physics.
• Experience as a validation engineer or previous experience in validation preferred.
• Strong written and verbal communication
• Excellent attention to detail

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