QA InspectorReq # JR - 021971 Location Hayward, California, United States Job Category Quality Control Date posted 06/10/2020
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(Exempt or Non-Exempt)
Manager I, Quality Operations/Quality Engineering
(Main purpose of the job)
This position is responsible for endorsing process and product quality through the routine assessment of in-process materials and finished goods. 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
(List of primary responsibilities of this role that account for 5% or more of the work. Incumbent may perform other duties as assigned.)
Inspection and release of production and in-process materials and components.
• Verify various manufacturing steps and techniques.
• Inspection of raw materials, finished goods and in-process 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.).
(To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. List knowledge, skills, and/or abilities required. Reasonable accommodations may be made to enable individuals with disabilities to perform essential functions.)
• 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.
(The physical demands described are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform essential functions. If not applicable, then edit or remove.)
• Regular attendance is necessary to perform the essential functions of the job.
• Light work, frequent lifting up to 40lbs; frequent standing/walking.Frequent standing and 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.
The work environment characteristics described are representative of those that an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform essential functions. If not applicable, then edit or remove.)
• 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.
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.
EEO is the Law
EEO is the law - Poster Supplement
Pay Transparency Policy
Baxter is committed to working with and providing reasonable accommodations to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application or interview process, please send an e-mail to Americas_TTA@baxter.com and let us know the nature of your request along with your contact information.