Manufacturing and Production

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Branch Information

Irvine, CA - McGaw (USA) 2525 McGaw Avenue CA Irvine , CA - 92614 Phone : 949-660-2172



Job Description

Job Description

Position Summary:

Under supervision, responsible for performing in-process inspections, process monitoring, quality support and investigations/resolution. Process monitoring includes AQL sampling, performing line clearances and line control. Provide quality support by performing tasks as assigned by Process Control Management.

Responsibilities: Essential Duties

*Perform manufacturing process verifications to ensure compliance with operating procedures and specifications (for example, verify proper line clearance, compliance with operating and inspection procedures, operation of equipment per validated parameters, equipment calibration, operator training, compliance with gowning and clean room procedures, etc.).

*Perform in-process AQL sampling not limited to particulate matter inspections, verification of product labeling, leak testing, and overall product quality to ensure conformance with process, procedures, and product release specifications.

*Provide a continuous quality presence on assigned manufacturing line.

*Report quality deviations to Process Control Lead/Supervisor in a timely manner.

*Provide support for quality investigations and resolution of quality issues such as documenting events or investigation results per applicable procedures.

*Provide quality decisions as need arises, i.e., product segregation, line stops, and escalation to lead/supervisor as necessary.

*Perform all activities with a working knowledge of company procedures and specifications

*Provide support to the manufacturing operation in all areas related to quality

*Maintain Instrument Usage and Calibration Logs based on instrument usage during the preparation and testing of samples.

*Demonstrate a quality mind-set capable of assessing and resolving discrepancies on the manufacturing lines.

*Maintain and ensure documentation records are accurate, complete and consistent with written procedures.

*Use computerized systems needed for batch record documentation and document control such as EBR (Electronic Batch Record) and SAP.

Qualifications- Experience/Training/Education


*HS diploma or GED and a minimum of 1-2 years of related experience.


*Bachelor's degree in a scientific discipline is preferred.

*Experience working in aseptic pharmaceutical manufacturing process is preferred.

*Familiar with FDA regulations pertaining to pharmaceutical manufacturing is preferred.

Expertise: Knowledge & Skill Requirements

*Requires good written and verbal communication skills.

*Requires good organization and computer skills.

*Ability to work within clearly defined SOP's and/or methods

*Ability to adhere to quality guidelines.

Job Type: Temporary