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QA Inspector II

AIC (part of ACS Group) • Hayward, CA

Posted 1 month ago

Job Snapshot

Biotechnology, Food, Manufacturing
Biotech, General Labor, Manufacturing

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Job Description


Top 3 must haves: previous experience in GMP/controlled environment, specifically visual or Quality inspection, must pass vision acuity requirements

Top Technical skills needed: previous experience using measurement tools (calipers/tappis/rulers), attention to detail, effective communication skills

Will they need to enter clean room? Yes

Potential for Exposure to Bloodborne Pathogens/Infectious Materials Yes


Any overtime, if yes how many hours: yes; less than 20 hrs/week including weekends

This position is responsible for endorsing process and product quality through the routine assessment of in-process materials and raw materials. In addition, to provide continuous improvement to the department through Quality Systems. Responsible for the inspection and verification activities in the manufacturing process. Must adhere to current Good Manufacturing Practices at all times.
Essential Duties and Responsibilities
* Inspection and release of production and in-process materials and components.
* Verify various manufacturing steps and techniques.
* Inspection of raw material components.
* Tagging and de-tagging of discrepant material.
* Release of packaged product into warehouse.
* Maintenance and disposal of quality retains.
* Archival of quality records.
* Any additional task assigned by the Supervisor.
* Support and participate with management during internal and external inspections as needed.
* Initiate minor documentation revisions.
* Support the corrective and preventive action process by recommending course of action and coordinating activity during exception situations.
* Responsible for gathering, analyzing, summarizing, and distributing process-relevant data.
* May train new staff members.
* Participate in continuous improvement initiatives such as Lean and 6-Sigma.
* Review documentation for accuracy and compliance to procedures, Obtain resolution on areas identified as non-conformance. Interpret and evaluate results in terms of acceptability to standards, procedures and regulatory requirements.
* Prepare and issue reports. Manage database including all QA personnel with the use of the Access program (trouble shooting, etc.) and modifications to the databases such as creating new reports, queries, forms, tables, etc.
* Participate in internal or external assessments, as required. Support process with timely closure of observations/audit items.
* Assist with audits of various reports (Protocols, Qualifications, Regulatory Submissions, etc.). Identify areas of non-conformance and inform management.
* Provide training to the quality department employees as areas are identified (e.g., Original Documentation Practices, Standard Operating Procedures, Quality Leadership, QA Database, etc.).

* Good working knowledge of Windows based applications.
* Ability to demonstrate strong organizational skills.
* Exercise judgment within defined procedures and practices.
* Work effectively independently and in team environment is a must.
* General knowledge of applicable quality and regulatory standards and regulations.
* General working knowledge in Lean and other continuous improvement tools.
* Must be a strong team player with good problem solving, and good verbal and written communication skills.
* Must be able to handle multiple projects concurrently, have computer experience and have knowledge of FDA Regulations, Application of Good Laboratory Practices, and Application of Good Manufacturing Practices.
* Knowledge of GMP documentation and FDA required.
* Demonstrated attention to details and accuracy, required.
* Must have good communication skills.
* General knowledge of quarantine and warehouse operation helpful.
* May be required to work flexible hours and overtime on short notice.
Education and/or Experience Bachelors with 0-2 years related experience or Associates with 1-3 years-related experience or High School diploma with 2-4 years of experience. Experience in a pharmaceutical or Biotech industry helpful. Must be familiar with cGMP and FDA requirements. Knowledge of aseptic techniques may be required.
Physical Demands
* Regular attendance is necessary to perform the essential functions of the job.
* Light work, frequent lifting up to 40lbs; frequent standing/walking.

Vision Requirement: Near point corrected vision must be at least 20/25. Vision checkup will be performed on an annual basis.
* Inspectors shall pass a standard eye test including a near vision acuity test. The results of the eye test must be at least 20/25 for near point corrected vision within both eyes (tested together) or country specific equivalent, e.g., 80% or 0.8 (European), or a Jaeger card score of
* If employees fail to meet the minimum vision standard, they should be referred to their optometrist for further correction. If the vision cannot be corrected, the employee must be assigned to other areas.

Working Environment
* No travel required.
* Normal office working conditions: computer, phone, files, fax, copier.
* Personal Protective Equipment: Latex-Free Gloves, safety shoes and safety goggles are required during the inspection process.

Job ID: 158656
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