Senior QA Specialist - QEV - Adma Biomanufacturing Llc
Boca Raton, FL 33487
About the Job
Conducts Change Review Board (CRB) to ensure that changes are initiated, evaluated, properly classified, authorized and implemented in accordance with Regulatory and Corporate requirements.
Coordinate and perform any additional activities or projects including the development of new procedures as assigned by QA management.
Perform QA review and approval of equipment, process, automation, PD, IT, QC, AD, cleaning and stability validation protocols and reports.
Proficient in 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 and procedures.
Resolve fundamental technical and regulatory issues, as well as resolve and negotiate quality related issues, as needed.
Utilize Quality Risk Management to identify, assess, control and review any potential impact to process, product or equipment. Suggests and initiates quality improvement plans.
Work closely with the Validation team and provide support to ensure documentation is accurate and complete.
Write and perform QA review and approval of additional documentation and quality systems such as SOPs, forms, reports, deviation, etc. as needed.
Write and perform QA review and approval of Change Control and Corrective Action Preventive Action (CAPA) Quality Systems. Independently evaluate required supporting documentation to support change and corrective/preventive actions.
Assist with internal, customer and regulatory audits.
Assist with new employee and on-going cGMP and quality related training as required.
Education Requirement:
Bachelors Degree required in a field related to the title of the position.
Experience Requirements:
Five to eight years experience in the pharmaceutical or biotechnology industry. Minimum of four years experience in FDA/CBER regulated 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
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.