Inspector, QAReq # JR - 025426 Location Hayward, California, United States Job Category Quality Control Date posted 08/06/2020
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This position is responsible for endorsing process and product quality through the routine assessment of raw materials and in- process materials. In addition, to provide continuous improvement to the department through Quality Systems. Must adhere to current Good Manufacturing Practices at all time.
- Perform the timely release of raw and in-process materials, making sure documentation is available and correct for release. Must adhere to current Good Manufacturing Practices at all times.
- Ensure that all inspection and chemical sampling are properly completed and documented.
- Review quality assessment and testing and determine whether to accept or reject materials or product during the inspection process.
- Initiate minor document revisions.
- Tagging and de-tagging of discrepant material.
- Release of packaged product into warehouse.
- Maintenance and disposal of quality retains.
- Control and verification of patient labels.
- Replace and monitor daily magnehelic gauge and freezer charts assigned in building D warehouse.
- Archival of quality records.
- Any additional task assigned by the supervisor.
- Support and participate with management during internal and external inspection 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.
- 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.
- Participate in internal or external assessments, as required. Support process with timely closure of observations/audit items.
- Assist with audits of various report (Protocols, Qualifications, Regulatory submissions, etc.). Identify areas of non-conformance and inform management.
- General working knowledge in Lean and other continuous improvement tools.
- Must be 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.
- 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 pharmaceutical or Biotech industry helpful.
- Knowledge of aseptic techniques may be required.
Equal Employment Opportunity
Baxter is an equal opportunity employer. Baxter evaluates qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, protected veteran status, disability/handicap status or any other legally protected characteristic.
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