Quality Assurance Associate I - 2nd Shift

The Role

The QA Associate I supports the Quality Assurance Operation on the 2nd Shift, which consists of QA Production Floor supports, and QA Product Release.

Responsibilities

• Provide Quality support to Manufacturing personnel on the shop floor for compounding and QA-in-process checks.
• Perform line clearance verification, sterilization chart review, scale calibration verification, and QA-in-process checks including but not limited to visual inspection, CSIT/PID test, weight check, and torque test.
• Prepare in-process samples for submission to the Quality Control laboratory.
• Support handling of GMP events and initiation of deviation investigations.
• Read, understand, and follow SOP’s and comply with cGMP and GDP.
• Support the issuance of GMP documentation to the Manufacturing floor.
• Review executed batch records for completeness, accuracy and compliance with approved procedures and Good Documentation Practices (GDP) and resolve discrepancies with manufacturing operators or supervisors.
• Use computerized systems and software such as SAP, LIMS, and TrackWise for data collection and batch record review.
• Enter and verify data from executed batch records into the Product Log Sheet and maintain the database up to date at all times.
• Initiate Certificate of Conformance and prepare executed batch records for product release in a timely manner to meet compliance requirements and business needs.
• Scan and file batch records (physically & electronically).
• Assist in writing and/or revising SOPs to ensure compliance with cGMP and other applicable regulations.

Requirements

• Working knowledge of QA principles in Pharmaceutical and/or other FDA regulated industries required.
• Good computer skills.
• Strong attention to detail.
• Good oral and written communication skills.
• Ability to work overtime and/or work on weekends as needed.

Qualifications

• Bachelor's Degree in Biochemistry, Chemistry, Engineering, Biology or closely related discipline required.
• 1-2 years' experience in Quality Assurance / Manufacturing environment in Pharmaceutical or other GMP regulated industries required.

Pay

Target Pay Range: $30-32/hour +10% Differential when working on 2nd Shift (2 PM -10:30 PM)

Benefits

• Medical, Dental, Vision, Life
• Voluntary Accident, Hospital
• 401K
• Generous Time Off Structure including PTO, Holidays, Sick & Personal