Quality Assurance (QA) Inspector II

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

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.
• QA inspection of bottled products and kits/sets.
• SAP Data Entry.
• Review and verification of completion of batch records and release products to Finished Goods Inventory.
• Absist in pulling and maintaining retains.
• 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
• Create and update Quality Notifications for process and product deviations or variance.
• Manage temperature monitoring for all QA freezers.
• Storage and handling of QA retain samples.
• Generate QA Retention Reports from SAP.
• Assist in training new QA Inspectors I’s.
• Evaluate SAP or any relevant software for bugs.
• Work with Technical Product Managers and/or R&D Program Managers to expedite problematic batches to FGI.
• Assist in reviewing and writing departmental policies, procedures and SOP’s.
• Generate monthly reports
• Evaluate resumes for new hires and participate in hiring function for QA Inspectors.
• Assist QA/RC department as necessary.
• Perform other related duties and assignments as required.