Quality Assurance Associate I - 2nd Shift

Alliance Medical Products, Inc.; Irvine (CA); On-site; USD 41,328 - 44,083; Full time

Benefits offered by this job

Medical

Dental

Vision

Life

Voluntary Accident

Hospital

Pet

401K

Generous Time Off (PTO, Holidays, Sick

Job summary

Alliance Medical Products, Inc. is seeking a QA Associate I to support the Quality Assurance operations on the 2nd shift (2 PM - 10:30 PM, Mon-Fri). You will assist QA production floor activities, conduct in-process checks, and execute batch reviews for product release.

The role requires a Bachelor’s degree in a relevant field and 1–2 years of QA/manufacturing experience in GMP environments. Compensation includes a 10% differential for the second shift and comprehensive benefits.

Qualifications

• 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.
• 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.

Responsibilities

• 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, TrackWise 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.

Skills

QA principles

Good computer skills

Attention to detail

Communication skills

Overtime/weekend flexibility

Education

Bachelor's Degree in Biochemistry, Chemistry, Engineering, Biology or related field

Tools

SAP

LIMS

TrackWise

Job description

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.

Responsibilities

• 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, TrackWise 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.

Required Knowledge, Skills and Abilities

• 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.

Required Education and Experience

• 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.

Target Pay Range

$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.

Benefits

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