Quality Assurance Associate - 2nd Shift

Your 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. 2nd Shift

Hours:

2 PM - 10:30 PM Monday through Friday.

• QA Production Floor Support:
  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 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 issuance of GMP documentation to the manufacturing floor.
• QA Batch Review and Product Release:
  Execute batch records review for completeness, accuracy and compliance with approved procedures and GDP; resolve discrepancies with manufacturing operators or supervisors; use systems such as SAP, LIMS, Track Wise for data collection and batch record review; enter and verify data; maintain the database; participate in deviation investigation and CAPA implementation; initiate Certificate of Conformance and prepare executed batch records for product release;
  
  scan and file batch records; assist in writing or revising SOPs to ensure compliance.

• 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 work on weekend as needed.

• 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.

$30-32/hour +10% differential when working on 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.

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