Quality Assurance Associate I - 2nd Shift

Siegfried AG; Irvine (CA); Sur place; USD 41 000 - 44 000; Plein temps

Avantages offerts par ce poste

Medical, Dental, Vision, Life

Voluntary Accident, Hospital, Pet

401K

Generous Time Off Structure including,

PTO, Holidays, Sick & Personal

Résumé du poste

Siegfried AG in Irvine, CA seeks a QA Associate I supporting QA operations on 2nd shift (2 PM–10:30 PM). You will provide QA support on the production floor for compounding and in-process checks, and assist in product release activities.

Responsibilities include line clearance, calibration verification, in-process sampling, reviewing batch records in SAP/LIMS/TrackWise, deviation investigations, and ensuring GMP/GDP compliance.

Qualifications

• QA principles knowledge required in pharmaceutical or FDA-regulated environments.
• Strong computer skills with exposure to electronic systems.
• High attention to detail and accuracy in documentation.
• Excellent verbal and written communication abilities.
• Ability to work overtime and weekends when needed.

Responsabilités

• Provide QA support on the production floor for compounding and in-process checks.
• Perform line clearance verification, calibration checks, and visual inspections.
• Review finished products via AQL and Level II visual inspections.
• Prepare in-process samples for QC and assist deviation investigations.
• Maintain GMP and GDP compliance and support SOP updates.

Connaissances

QA principles

Computer skills

Attention to detail

Communication skills

Overtime availability

Formation

Bachelor's Degree in Biochemistry, Chemistry, Engineering, Biology

Outils

SAP

LIMS

TrackWise

Description du poste

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

Your Profile:

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 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 SOP's and comply with cGMP and GDP.
• Support the issuance of GMP documentation to the Manufacturing floor.

QA Batch Review and Product Release

• 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.
• 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.

Required Knowledge, Skills and Abilities

• 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 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.

Your Benefits:

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

Founded in 1873 in Zofingen, Switzerland, Siegfried has grown into a global network of 16 sites across three continents. With a team of more than 4,200 highly skilled professionals, we take the innovations of our pharmaceutical customers to industrial scale and manufacture safe drugs for patients worldwide. As a fully integrated CDMO, Siegfried is one of the few organizations today that can carry out the development and manufacturing of APIs and finished dosage forms under one roof. This unique combination of know-how and experience makes us the most trusted partner in the pharmaceutical industry.