Associate, Validation

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 is a biopharmaceutical company relentlessly committed to creating superior products for immunodeficient patients at risk for infection. It is our devotion to this underserved population that fuels us and our hands-on approach to production and development that sets us apart. If you are looking for a dynamic, innovative, growing company in the biopharmaceutical industry that is committed to excellence and integrity, then consider ADMA Biologics. We currently have an exciting opportunity available for an Associate, Validation in Boca Raton, Florida!

Job Title: Associate, Validation

Job Description:

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 also identify, communicate, and assist in the execution of various validation protocols.

This is an onsite position in Boca Raton, Florida.

Essential Functions (ES) and Responsibilities

• Conduct 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.
• Responsible for collecting 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.
• Responsible to 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.

Competencies

FDA Adherence

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.

Job Description Footer:

In addition to competitive compensation, we offer a comprehensivebenefits package including:

• 401K plan with employer match and immediate vesting
• Medical, Vision, Life and Dental Insurance
• Pet Insurance
• Company paid STD and LTD
• Company Paid Holidays3 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 uses E-Verify to confirm the employment eligibility of all newly hired employees. To learn more about E-Verify, including your rights and responsibilities, please visit www.dhs.gov/E-Verify .

ADMA Biologicsis an Equal Opportunity Employer.