Quality Assurance Associate I - 2nd Shift

About the Role

As a QA Associate I, you will support the Quality Assurance Operation on the 2nd Shift, focusing on QA Production Floor support and QA Product Release.

2nd Shift Hours: 2 PM - 10:30 PM, Monday through Friday

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.
• Perform AQL and Level II Visual Inspection for Finished products.
• 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 SOPs 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); 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.
• Participate in deviation investigation and CAPA implementation.
• 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

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

Skills

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

Pay

Target Pay Range: $30-32/hour + 10% Differential for 2nd Shift (2 PM - 10:30 PM). Individual compensation packages are based on various factors unique to each candidate, including skill set, experience, qualifications, and other job-related reasons.

Benefits

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