Associate, Validation

ADMA BioCenters; Boca Raton (FL); On-site; USD 50,000 - 70,000; Full time

Benefits offered by this job

401K plan with employer match

Medical, Vision, Life and Dental Insurance

Pet Insurance

Company paid STD and LTD

Company Paid Holidays

3 Weeks’ Paid Time Off

Tuition Assistance

Free shuttle to Boca Tri-Rail station

Job summary

ADMA BioCenters in Boca Raton, FL is seeking an Associate, Validation to perform validation inspections and ensure compliance during the manufacturing process. Responsibilities include conducting qualification tests, updating Standard Operating Procedures (SOPs), and collaborating with teams for process enhancements.

Qualified candidates must possess a Bachelor's Degree and a minimum of 2 years of experience in a regulated cGMP or manufacturing environment. The role offers benefits like a 401K plan, medical insurance, and paid time off.

Qualifications

• Minimum of 2 years of validation and manufacturing experience.
• Experience in a cGMP regulated environment is preferred.
• Strong understanding of FDA regulations.

Responsibilities

• Conduct performance qualification tests for equipment.
• Execute temperature mapping studies for equipment.
• Update SOPs and revise documents as required.
• Perform cleaning validation procedures to ensure compliance.
• Collaborate with cross-functional teams for process improvements.

Skills

Validation inspections

cGMP knowledge

Regulatory compliance

Cross-functional collaboration

Education

Bachelor’s Degree

Job description

Associate, Validation in Boca Raton, FL

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.

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.

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

Strict adherence to FDA regulations and company policies governing daily operations. Includes completion of required compliance training, accurate documentation, 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 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 Biologics is an Equal Opportunity Employer.