QA Associate – Solid Oral Dosage Manufacturing

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Shift: Sunday–Thursday, 10:00 PM – 6:30 AM

Job Description:

• Ensure quality assurance during manufacturing of solid oral dosage pharmaceutical products
• Perform real-time review of batch records, room/equipment clearances, in-process and finished product testing
• Support and initiate deviation investigations, maintain compliance with cGMP, SOPs, and FDA regulations
• Collaborate with cross-functional teams to ensure production quality

Must-Have Skills:

• QA experience in GMP-regulated pharmaceutical manufacturing
• Strong knowledge of cGMP, FDA CFR guidelines, and SOPs
• Experience with solid oral dosage forms (tablets, capsules, etc.)
• Batch record review and real-time QA support on manufacturing floor
• In-process and finished product testing (e.g., particle size, bulk density, moisture)
• Familiar with inventory systems like JD Edwards
• Excellent documentation, communication, and problem-solving skills
• Comfortable with night shift (10 PM–6:30 AM, Sun–Thurs)

Preferred Qualifications:

• Bachelor's in a science or technical field + 2 years’ QA experience (OR)
• High School Diploma + 4 years’ QA experience in regulated environment
• Knowledge of Lean Six Sigma, ASQ certifications (a plus)

• Associate

• Contract

• Information Technology
• Industries:
  Software Development

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