US-CA-Van Nuys: QA Inspector

To see other opportunities, please visit http://sqa.fyicenter.com
Date: 08-Feb-2008

QA Inspector

Job Description

1. Monitor product quality through the performance of required visual and functional testing. Maintain a working knowledge of statistically based Sampling Plans and their applications.

2. Promote process control through activities in support of equipment and process validations. These activities are primarily product checks that support or refute validation studies.

3. Monitor processes through the implementation of World Class Manufacturing Strategies, including Statistical Process Control (SPC). Responsible for generating and interpreting SPC control charts.

4. Ensure the accuracy of measuring and testing equipment through the performance of calibrations.

5. Perform periodic audits of manufacturing practices and local procedures. Procedural changes in response to these audits may be initiated and coordinated by the QA Inspector.

6. Support the corrective and preventive action program by assisting with exception situations.

7. Responsible for gathering, analyzing, summarizing, and distributing process-relevant data.

8. Promote continuous improvement through participation (i.e. team leader/facilitator or major contributor) in Process Management Team program.

9. Handle customer complaints in timely manner. This includes sample analysis, batch record review, historical trend reviews, root cause identification, and official documentation of findings.

10. Must be able to effectively communicate across all departments and levels of management.

Job Requirements

1. Knowledge of GMP documentation and FDA required.

2. Demonstrated attention to details and accuracy, required. Must have good communication skills.

3. General Knowledge of quarantine and warehouse operation helpful. May be required to work flexible hours and overtime on short notice.

4. Bachelors with 0-2 years related experience or Associates with 1 - 3 years -related experience or High School diploma with 2-4 years experience.

5. Experience in a pharmaceutical or Biotech industry helpful.

6. Must be familiar with cGMP and FDA requirements.

7. Knowledge of aseptic techniques may be required.

For more information, please write to us.

Thank you,
Team SQAFYI - Software QA Resource FYI
http://sqa.fyicenter.com