Validation Associate — cGMP, FDA-Ready (Onsite Boca)

ADMA Biologics; Boca Raton (FL); On-site; USD 65,000 - 90,000; Full time

Benefits offered by this job

401K plan with employer match

Medical, Vision, Life and Dental

Pet Insurance

STD and LTD

Holidays & PTO

Tuition Assistance

Shuttle service to Tri-Rail

Job summary

ADMA Biologics in Boca Raton, FL seeks an Associate, Validation to perform validation inspections, cleaning, and tests during manufacturing. You will compile observations, interpret data, and assist in executing validation protocols in an onsite role.

The position emphasizes compliance with FDA regulations and GMP standards. Ideal candidates have a Bachelor's degree and at least 2 years of validation or manufacturing experience, with a track record in regulated environments.

Qualifications

• Bachelor's degree required in a relevant field.
• Minimum of 2 years of validation, cGMP, FDA, or manufacturing experience.

Responsibilities

• Conduct performance qualification tests to validate equipment performance.
• Execute temperature mapping studies to evaluate distribution.
• Execute validation studies in line with regulatory requirements.
• Update SOPs to reflect current practices and standards.
• Perform cleaning validation procedures including rinse and swab tests.
• Perform equipment operation qualification tests for process parameters.
• Collect samples for laboratory analysis and document deviations.
• Verify proper installation of equipment through inspections.
• Identify opportunities for process improvements in validation procedures.
• Collaborate with cross-functional teams to communicate findings.

Skills

cGMP knowledge

FDA regulations

Quality systems

Education

Bachelor's Degree

Job description

ADMA Biologics in Boca Raton, FL seeks an Associate, Validation to perform validation inspections, cleaning, and tests during manufacturing. You will compile observations, interpret data, and assist in executing validation protocols in an onsite role.

The position emphasizes compliance with FDA regulations and GMP standards. Ideal candidates have a Bachelor's degree and at least 2 years of validation or manufacturing experience, with a track record in regulated environments.