Associate II, Lab Support

Associate II, Lab Support ADMA Biologics - 2.5 Boca Raton, FL Job Details Full-time 1 day ago Benefits Paid holidays Disability insurance Health insurance Dental insurance Tuition reimbursement Paid time off Vision insurance 401(k) matching Qualifications Stability testing Record keeping Laboratory inventory control Sample preparation Procedural guides Technical documentation Pharmaceutical regulatory compliance GMP Mid-level Administrative experience Laboratory regulatory affairs Laboratory quality control Laboratory techniques Cleaning Technical writing Cross-functional collaboration Communication skills Regulatory compliance management Cross-functional communication FDA regulations Full 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 II, Lab Support in Boca Raton, FL!

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Associate II, Lab Support Job Description:

Position Summary The Associate II, Lab Support, performs cGMP laboratory support activities including Sample Accessioning, Product Reserve management, Glassware Cleaning, Supply Inventory management, etc. May also assist with Stability Studies and other QC initiatives. Performs all work under GMP conditions. Provides customer support to QC analysts and works cross functionally with other departments Essential Functions (ES) and Responsibilities Performs cGMP laboratory support activities such as: Customer support functions for QC laboratories such as cleaning glassware, , shipping samples, sample preparation, and administrative support. Providing QC functions for product, such as assisting with Stability, Appearance, and Reserve programs, sample accessioning, providing information to internal and external customers. Utilizes and adheres to cGMP practices in documentation and execution of job functions. Completes documentation to ensure compliance with specifications and procedures. Performs other assigned QC Lab Support initiatives. Performs, reviews and trains on processes performed within the department. Writes and revises technical documentation for department areas of responsibility such as SOP's, Stability Protocols and Final Reports, Specifications, etc Trains to become an appearance inspector / performers appearance inspections. Trains on and perform Particulate Matter USP testing. Interacts with others, both within and outside the department, to provide customer support on issues related to department functions. Ensures that assigned Laboratory Support areas meet all regulatory requirements by verifying procedures are being followed, all recordkeeping is current, proper maintenance occurs and new requirements are identified as they arise. Assists in other functions, as assigned by the Manager. Job Responsibilities or Job Requirements Competencies Able to work in high-pressure, deadline-driven environment Demonstrated ability to achieve goals, overcome obstacles, and meet deadlines Exceptional organizational and communication skills required Experience Requirements Preferred Experience 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.

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In addition to competitive compensation, we offer a comprehensive benefits package including: 401K plan with employer match and immediate vesting Medical, Vision, Life and Dental Insurance Pet InsuranceCompany 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. Apply now