Specialist QA II Manufacturing Oversight

BioSpace; Boca Raton (FL); On-site; USD 85,000 - 120,000; Full time

Job summary

ADMA Biologics is seeking a Specialist QA II Manufacturing Oversight in Boca Raton, FL. The role oversees real-time quality activities, reviews batch records and manufacturing documentation, and ensures adherence to SOPs and regulatory requirements.

Applicants should have 3–5 years in pharma/biotech, a Bachelor's degree preferred, and strong writing and communication skills. Knowledge of LIMS/SAP is a plus; FDA compliance is essential.

Qualifications

• Bachelor's degree preferred, or equivalent experience.
• 3-5 years' experience in pharmaceutical/biotechnology industries.
• Strong written and verbal communication and meticulous documentation.
• Knowledge of FDA regulations and cGMP practices.

Responsibilities

• Perform real-time batch record review and QA approvals.
• Review manufacturing documentation, logs, charts, and SOPs.
• Inspect active production areas to ensure SOP and policy compliance.
• Review and release plasma pools and raw materials in LIMS/SAP; perform Lookback disposition.
• Write, review, and revise QA SOPs; assist with training new staff.

Skills

Organizational skills

Communication skills

Education

Bachelor's degree preferred

Tools

LIMS

SAP

Job description

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 a Specialist QA II Manufacturing Oversight in Boca Raton, FL! Job Title: Specialist QA II Manufacturing Oversight

Position Summary

The QA Specialist II - Manufacturing Oversight will perform manufacturing oversight activities to ensure compliance with policies and procedures. Oversight activities include, but are not limited to, real-time manufacturing batch record review, review of manufacturing documentation (logs, charts, etc.), and resolution of issues on the manufacturing floor.

Essential Functions (ES) And Responsibilities

• Possess and understanding of processes such as Quality Systems (e.g., Deviations, Corrective and Preventive Action reports {CAPAs}, Change Controls, and Out of Specifications {OOSs}).
• Perform Quality Assurance review and approval of Deviation Reports.
• Possess an understanding cGMP and regulatory compliance as defined in government regulations such as 21 CFR Parts 11, 210, 211, and 600.
• Perform oversight and inspections of active production areas to resolve problems and to ensure compliance with SOPs and policies.
• Perform general oversight of Buildings 1 and 2 (including cold rooms/freezers) and their associated activities, as required.
• Review and release of Plasma pools to manufacturing.
• Review all manufacturing support documentation (logbooks, log sheets, charts, etc.)
• Review and release of raw materials in LIMS/SAP.
• Perform audits of Nitrogen receipt process.
• Perform notification and disposition of associated Lookback units.
• Assist with quarantining and release of critical systems, equipment, and controlled environments.
• Write, review, and revise QA SOPs.
• Review SOPs and documents from other departments and provide feedback as necessary.
• Work with other departments to assess if Deviations, CAPAs, and Change Controls are required.
• Assist with training of new employees.
• Coordinate and perform any additional activities or projects assigned by QA Management.
• Experience with LIMS and SAP preferred.

Job Responsibilities or Job Requirements Competencies Exceptional organizational and communication skills requiredMust have excellent writing and oral skillsExperience Requirements

EDUCATION REQUIREMENTS:

• Bachelor's Degree preferred but can be offset by experience.

EXPERIENCE REQUIREMENTS:

• 3-5 years' experience in pharmaceutical or biotechnology industry or other related industry.

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.

Job Description Footer:

• 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.