PRIMARY PURPOSE or JOB SUMMARY

To support QA Manufacturing activities on the production floor

ESSENTIAL DUTIES AND RESPONSIBILITIES include the following. Other duties may be assigned.

1. Ensure that products are manufactured according to cGMP requirements.

1. Perform of walkthroughs of GMP areas to ensure inspection readiness of facility is maintained; includes documentation, follow-up and escalation of observations, and areas of concern.

1. Use some level of judgment and has ability to propose different solutions with guidance.

1. Perform verifications of documents related to the manufacturing operations.

1. Perform in-process testing (pH, specific gravity, titrations, etc.).

1. Perform batch calculations.

1. Perform QS verifications.

1. Verify cleaning procedures.

1. Sample collection.

1. Data Entry.

1. Maintenance and revision of applicable procedures.

1. Any other Quality Assurance duties as assigned by management.

ACCOUNTABILITY

For the compliance, accuracy and timeliness of responsibilities and work assigned. Maintain skill set by remaining current in industry standards and best practices through workshops, webinars etc.

SUPERVISORY RESPONSIBILITIES

NONE

QUALIFICATIONS

• Experience – minimum of two years in quality assurance or quality control

• Two year college degree or combination of education and experience

• Detailed, critical thinking skills

• Good communication skills – verbal and written