QA Supervisor

Job DetailsLevel ManagementJob Location ADMA Biologics - Boca Raton, FLRemote Type N/APosition Type Full TimeEducation Level 4 Year DegreeSalary Range UndisclosedTravel Percentage UndisclosedJob Shift DayJob Category QA - Quality ControlDescription

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 a Quality Assurance Supervisor!

 

The QA Supervisor oversees manufacturing operations to ensure compliance with cGMPs, GDPs, exception reporting and continuous improvement. Ensures daily MQA observations and other self-audit observations are properly documented, communicated, trended, and corrected appropriately to ensure continuous compliance with cGMPs, corporate policies, standards, and procedures.

Qualifications

• Ensure cGMP and regulatory compliance as defined in government regulations such as 21 CFR Parts 11, 210, 211, and 600, as well as compliance with corporate policies, standards, and procedures.

• Interact with Manufacturing (Fractionation/Purification/Fill Finish), Quality Control, Facilities/Engineering and other production support units to develop and implement corrective actions and process improvements.

• Maintain a system for documenting observations daily MQA walkthroughs and other self-audit observations.

• Ensure observations are properly documented, communicated to appropriate responsible departments, and corrective actions are timely executed.

• Conduct trending of observations from daily quality audits, ensure appropriate corrective actions are initiated as adverse trends are identified, and communicate trending results to management.

• Perform review of GMP documents (e.g. batch production records, batch testing records, etc.) to ensure compliance with GDPs, data integrity corporate policies, standards, and procedures.

• Establish and maintain processes for real-time data review in Manufacturing.

• Work with production personnel and other departments to resolve documentation and compliance issues.

• Coach, mentor, and develop staff, including overseeing new-employee on-boarding.

• Organize and present data/information on assigned projects to management.

• Author and revise SOP, Work Instructions, Forms, as needed.

• Coordinate and perform any additional activities or projects assigned by Quality Management.

• Ensure timely escalation to senior management of any quality and compliance matters and/or deviations from the approved processes, policies/standards/procedures, discovered during the oversight of manufacturing operations and audits of other areas on site.

 

Education Requirements:         

Bachelor’s degree preferred but can be offset by experience.

Experience Requirements:       

Three to five years’ experience in pharmaceutical or biotechnology industry or other related industry.

 

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 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

Fast growing company. Redesigning HR of the future for ADMA. Benefit eligible on day 30. 100% paid dental, eye care, life insurance, STD and LTD. 75% employer paid medical with low premiums. PTO consists of 12 days per year for the first two years and then goes up from there, holidays, and three floating holidays. 4% match 401k vested from day 1. Pet insurance with very low premium.

 

Just awarded 2023 Best Places to Work!

 

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.