QA Specialist: Manufacturing Oversight (12h Shifts, 24/7)

BioSpace; Boca Raton (FL); On-site; USD 60,000 - 80,000; Full time

Benefits offered by this job

401K with employer match

Medical, Vision, Life and Dental

Pet Insurance

Company paid STD and LTD

Company Paid Holidays

3 Weeks’ Paid Time Off

Tuition Assistance

Free shuttle to Tri-Rail

Job summary

ADMA Biologics in Boca Raton, FL is seeking a Specialist QA I Manufacturing Oversight to perform manufacturing oversight, review batch records, and ensure compliance with cGMP and FDA regulations. The role includes real-time documentation review and support across 12-hour shifts to ensure 24/7 coverage.

Ideal candidates have 1–3 years in pharma/biotech and a Bachelor's degree (or equivalent experience). Training and compliance are emphasized, with strong QA and documentation skills required.

Qualifications

• 1–3 years’ experience in pharmaceutical or biotechnology industry preferred.
• Bachelor's Degree preferred but can be offset by experience.

Responsibilities

• Perform real-time batch record reviews and QA approval of events.
• Review and release plasma pools to manufacturing.
• Oversee compliance with cGMP and regulatory guidelines (21 CFR Part 11, 210, 211, 600).
• Coordinate and perform additional QA oversights and audits as needed.

Skills

Attention to detail

Education

Bachelor's degree

Tools

LIMS

SAP

Job description

ADMA Biologics in Boca Raton, FL is seeking a Specialist QA I Manufacturing Oversight to perform manufacturing oversight, review batch records, and ensure compliance with cGMP and FDA regulations. The role includes real-time documentation review and support across 12-hour shifts to ensure 24/7 coverage.

Ideal candidates have 1–3 years in pharma/biotech and a Bachelor's degree (or equivalent experience). Training and compliance are emphasized, with strong QA and documentation skills required.