Description

You will provide quality support for the manufacturing of solid oral dosage products, ensuring compliance with cGMP, CFR, and SOP requirements.

Responsibilities

• Monitor manufacturing operations in real time to ensure regulatory compliance.
• Review and approve batch records, SOP revisions, and in-process or finished product samples.
• Perform room and equipment clearances, including microbial swabbing for environmental monitoring.
• Conduct routine testing on samples for particle size, bulk density, moisture analysis, appearance, and AQL.
• Initiate deviation reports in Trackwise and assist in investigations through data gathering and root cause analysis.

Required Skills

• Bachelor’s Degree in a related science or technical field with 2 years of experience (or High School Diploma with 4+ years in regulated GMP manufacturing).
• Experience with Good Laboratory Practices (GLP) and basic laboratory instrumentation.
• Proficiency in technical documentation, technical writing, and excellent handwriting skills.
• Strong mathematical, computer, and Microsoft Office skills, including MS Word and MS Excel.
• Ability to perform data management and follow complex written and verbal instructions.
• Demonstrated problem-solving and decision-making skills within a regulated environment.
• Experience with continuous improvement techniques.

Preferred Skills

• Lean Six Sigma or ASQ certification.

Key Skills

Education

Bachelor's Degree