Quality Assurance

2 weeks ago

San Diego, United States MILLENNIUMSOFT Full time

Quality Assurance (QA) Inspector II[14419]
San Diego, CA

3 Months Contract

6 AM to 2:30 PM

Weekly 40 hours

Qualifications:
• Detailed-Oriented, can deal with ambiguity, team player & must be able to work independently and with minimal supervision. Fast learner and must have excellent communication skills.

• Computer skills required, such as Microsoft Word, Microsoft Excel and the use of email. SAP & Outlook knowledge preferred.

• Requires organizational skills and the ability to follow verbal and written instructions.

• Must be able to lift 35 pounds.

• Must be able to work in different temperature environments such as room temperature, 4C, -20C and -80C.

• Local travel is required for inspection of products at different Client Biosciences - San Diego facilities.

EDUCATION AND EXPERIENCE Required High School Diploma or equivalent. College degree or college level science courses helpful. 2 to 5 years’ experience in General office, computer data entry, QA inspection experience in manufacturing industries THE ABOVE STATEMENTS ARE INTENDED TO DESCRIBE THE GENERAL NATURE AND LEVEL OF WORK BEING PERFORMED BY PEOPLE ASSIGNED TO THIS JOB. THIS JOB DESCRIPTION IS NOT INTENDED TO BE AN EXHAUSTIVE LIST OF ALL RESPONSIBILITIES, DUTIES, AND SKILLS REQUIRED OF EMPLOYEES SO CLASSIFIED.

Responsibilities:

  • Responsible for visual inspection of bottled products, components & kits, making sure the vials have correct volume, proper label description, material number, batch number and storage temperature.
  • Review packaging batch records to ensure the correct Technical Data Sheet and any applicable inserts are attached.
  • Review dilution, bottling & packaging processes to ensure all finished products meet specifications prior to releasing products to Finished Goods Inventory or Inventory Control for bottled components.
  • File QA retention samples in QA Retention Sample inventory.
  • The QA Inspector II will also be responsible for supporting external customers as well as the following internal customers: Operations, Packaging, Production Planning, Technical Product Managers and Inventory Control.

RESPONSIBILITIES

  • 1. QA inspection of bottled products and kits/sets.
  • 2. SAP Data Entry.
  • 3. Review and verification of completion of batch records and release products to Finished Goods Inventory.
  • 4. Assist in pulling and maintaining retains.
  • 5. Create and update department procedures , work instructions in the SAP ECR system with input from Operations, Packaging, Production Planning, Technical Product Managers and Inventory Control
  • 6. Create and update Quality Notifications for process and product deviations or variance.
  • 7. Manage temperature monitoring for all QA freezers.
  • 8. Storage and handling of QA retain samples.
  • 9. Generate QA Retention Reports from SAP.
  • 10. Assist in training new QA Inspectors I’s.
  • 11. Evaluate SAP or any relevant software for bugs.
  • 12. Work with Technical Product Managers and/or R&D Program Managers to expedite problematic batches to FGI.
  • 13. Assist in reviewing and writing departmental policies, procedures and SOP’s.
  • 14. Generate monthly reports
  • 15. Evaluate resumes for new hires and participate in hiring function for QA Inspectors.
  • 16. Assist QA/RC department as necessary.
  • 17. Perform other related duties and assignments as required.


Comments/Special Instructions :

  • Overtime as required, this could include an occasional Saturday. Travel includes from one local client plant to another local client Plant approximately 16 miles round trip.

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