Quality Engineer III - Quality Ops Review

Company: TEKNOVA
Location: Hollister
Posted on: June 21, 2022

Job Description:

Description:OVERVIEWThe Quality Engineer III will be responsible to ensure the overall quality of manufactured products and is tasked with reviewing current processes for continuous improvement supporting the Quality Operations Department reporting to the Director, Quality Operations.The role is essential to assure that the Teknova site manufacturing and operations activities comply with applicable regulatory standards (e.g., ISO13485:2016, 21CFR Part 820, and Current Good Manufacturing Practices, Good Distribution Practices where applicable) and expectations for the development and reliable supply of quality products (Including Broths/Buffers/Plates).DUTIES AND RESPONSIBILITIES

• Review Batch Records for accuracy and completeness, and improvement opportunities
• Review WIP receipt and QC reject records for complete then release
• Review work Orders for completeness and accuracy
• Ensure labels and any supporting documentation for product release are complete and accurate
• Use an ERP system to track and transfer records of non-Finished Goods into inventory
• Confirm that Finished Goods documentation compliant with cGMPs and Teknova policies and procedures
• Ensure the proper isolation of rejected material generated during batch process and document accountability in the packaging / labeling record
• Ensure that all packaging and labeling components are sampled, inspected, and tested (where applicable) for the purpose of determining compliance with established specifications
• Disposition of rejected material as per procedures
• Responsible for the receipt, inspection, release, reconciliation, and control of labels and inserts for all products
• Assist with developing, reviewing, and improving procedures and processes related to product quality.
• Proactively identify and work collaboratively to resolve problems taking risk-based and compliant approaches to solutions.
• Promote a quality mindset and quality excellence approach to all activities.
• Promote and encourage a safety mindset and focus on safety for all operations activities.
• Assisting the Quality Assurance department with various projects and administrative tasks. Requirements:EDUCATION
  • Minimum of BS in Chemistry, Engineering, Biological Sciences, or a similar scientific discipline
  • Minimum of 5 years of Quality knowledge within a Medical Devices, Diagnostics, Pharmaceutical or other regulated industryKNOWLEDGE / SKILLS / EXPERIENCE
    • Working understand requirements for ISO 13485, 21 CFR 820 and other applicable regulations
    • Ability to review data/metrics utilizing MS Office Applications Excel, Word, PowerPoint, or Power BI
    • Self-motivated, flexible, and able to work in a small, fast-paced, dynamic, environment.
    • Excellent interpersonal and written communication skills and experience using various software/electronic applications required.
    • Experience working in a GMP or manufacturing environment preferred or similar "clean" environments.
    • Must be able to walk, bend, carry, lift, push and pull 45 pounds
    • Must be willing to work a 4/10 schedule (Sunday-Wednesday or Wednesday-Saturday)EEOC Employer

Keywords: TEKNOVA, Salinas , Quality Engineer III - Quality Ops Review, Engineering , Hollister, California