Quality Assurance Specialist - job 1 of 2

Hi, we are looking for Quality Assurance Specialist with the following requirements-

Hybrid Role-minimum 50% onsite
Detailed Position Responsibilities

• Oversee the qualification of process automation systems, Analytical and manufacturing instruments, manufacturing execution systems, databases, and IT infrastructure.
• Interface with MS&T, Validation, and end user groups as a Quality subject matter expert to provide technical validation guidance related to GxP compliance, design and requirements development, software testing, system administration, data management, and risk-management.
• Support the implementation and maintenance of Computer System changes, aligning with site compliance policies and procedures.
• Review and approve qualification protocols and test scripts, user acceptance testing, reports, change management, and authorization for use documentation.
• Ensure that all regulatory and cGMPs compliance items related to validation are satisfied.
• Review and approve exceptions associated with the qualification and participate in resulting investigations and correction / corrective action planning.

Desired Experience and Education:

• Knowledge of science generally attained through studies resulting in a Bachelor’s Degree in a scientific or engineering discipline.

•Experience in an environment governed by cGMPs, in a computer systems validation or quality assurance validation role overseeing electronic equipment and computerized systems validation.

• Detailed knowledge of cGMP and regulatory requirements for validation of equipment,

computerized systems, and processes.

• Proficiency in the use of computers and software applications including electronic

validation documentation systems (such as ValGenesis and ALM).

• Interface with many functional areas including Manufacturing Science and Technology,

Digital Plant, Manufacturing, Validation.

Thanks,

Shilpi| Sr. Recruitor

shilpi@vastekgroup.com| 703-263-8242

Job Type: Full-time

Salary: $27.00 - $34.00 per hour

Benefits:

• Health insurance

Experience level:

• 1 year
• 2 years
• 3 years
• Under 1 year

Schedule:

• 8 hour shift
• Day shift
• Monday to Friday
• Weekends as needed

Work setting:

• In-person
• Office

Work Location: In person

Speak with the employer
+91 703-263-8242