Description

You will ensure GMP compliance and quality standards throughout the manufacturing of solid oral dosage pharmaceutical products.

Responsibilities

• Audit batch records in real-time for completeness, documentation accuracy, and conformance to critical process parameters.
• Perform room and equipment clearances and microbial swab testing for environmental monitoring.
• Conduct routine testing of in-process and finished product samples, including particle size, bulk density, and moisture analysis.
• Initiate deviation reports in Trackwise and support investigations through data gathering and root cause analysis.
• Manage the quality status of WIP and finished goods within JD Edwards.
• Recommend SOP and batch record changes and review proposed revisions.

Required Skills

• Experience in a regulated GMP manufacturing environment.
• Knowledge of cGMP and CFR guidance applicable to solid oral dosage products.
• Proficiency in technical documentation and data management.
• Ability to perform real-time production monitoring and risk management.
• Experience with QA processes and production management.
• Capability to support change management and site process improvements.
• High School Diploma with 4+ years of relevant experience, or a Bachelor’s degree in a related science field with 2+ years of experience.

Preferred Skills

• Lean Six Sigma or ASQ certification.

Key Skills

Education

Bachelor's degree