Associate, Validation

Position Summary

The Associate, Validation performs various validation inspections, cleaning, checks, and tests during the manufacturing process. This role also compiles, interprets, and records observations of production processes. You will identify, communicate, and assist in the execution of various validation protocols.

Essential Functions (ES) and Responsibilities

• Cover performance qualification tests, such as homogeneity studies, to validate equipment performance and consistency in producing reliable results.
• Execute temperature mapping studies to evaluate temperature distribution within equipment and identify potential areas of concern.
• Execute validation studies, ensuring adherence to regulatory requirements and industry best practices.
• Update Standard Operating Procedures (SOPs) and revise documents as needed to reflect current practices and standards.
• Perform cleaning validation procedures, involving rinse and swab sampling tests, to confirm equipment cleanliness and compliance with sanitation guidelines.
• Perform equipment operation qualification tests, including assessing flow rates, temperature settings, and other parameters to ensure equipment operates accurately and reliably.
• Collect samples for submission to laboratory for analysis, data entry of deviations, and review data to ensure accuracy, completeness and compliance with established SOPs.
• Verify the proper installation of equipment by conducting thorough inspections and assessments to ensure compliance with regulatory and company standards.
• Proactively seek opportunities for process improvements and recommend changes to enhance operational efficiency in validation procedures and SOPs.
• Collaborate closely with cross-functional teams to communicate findings and contribute to the enhancement of equipment and processes.

Job Responsibilities or Job Requirements

Competencies
Experience Requirements
Preferred Experience
Education Requirements: Bachelor’s Degree required.

Experience Requirements

• Minimum of 2 years of validation, current Good Manufacturing Practices (cGMP), FDA, and/or manufacturing experience to ensure compliance with regulations.
• Demonstrated experience/proficiency/knowledge/training in a regulated cGMP, manufacturing, or pharmaceuticals environment preferred.

Compliance Requirements (ES)

• The minimum compliance expectation for this role entails strict adherence to FDA regulations and company policies governing sales and marketing activities. This includes completion of required compliance training, accurate documentation of sales interactions, and adherence to data privacy regulations. Additionally, the role requires proactive participation in compliance reviews, prompt reporting of any potential issues, and ongoing education to stay updated on relevant FDA regulations.

Benefits

• 401K plan with employer match and immediate vesting
• Medical, Vision, Life and Dental Insurance
• Pet Insurance
• Company paid STD and LTD
• Company Paid Holidays
• 3 Weeks’ Paid Time Off (within the first year)
• Tuition Assistance (after the first year)
• Easily accessible to Tri-Rail. Free shuttle to the Boca Tri-Rail station

ADMA Biologics

ADMA Biologics is an Equal Opportunity Employer.