QA Associate – Solid Oral Dosage Manufacturing

Zolon Tech Inc.; Winchester (KY); On-site; USD 50,000 - 60,000; Full time

Job summary

A leading company in the pharmaceutical field is seeking a QA Associate for solid oral dosage manufacturing. This role requires expertise in quality assurance and compliance with industry standards. The QA Associate will conduct thorough reviews of batch records and engage in rigorous testing to ensure product quality.

Qualifications

• 2 years’ QA experience (or 4 years with high school diploma).
• Knowledge of Lean Six Sigma and ASQ certifications is a plus.

Responsibilities

• Ensure quality assurance during manufacturing of solid oral dosage products.
• Perform real-time review of batch records and in-process testing.
• Support deviation investigations and maintain compliance with regulations.

Skills

QA experience in GMP-regulated pharmaceutical manufacturing

Knowledge of cGMP

Knowledge of FDA CFR guidelines

Solid oral dosage forms knowledge

Batch record review

In-process and finished product testing

Excellent documentation skills

Strong communication skills

Problem-solving skills

Comfortable with night shifts

Education

Bachelor's in a science or technical field

High School Diploma

Tools

JD Edwards

Job description

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)

Seniority level

• Associate

Employment type

• Contract

Job function

• Information Technology
• Industries: Software Development

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