Quality Assurance Specialist

Job Description

Job Summary:

• 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 I will also be responsible for supporting external customers as well as the following internal customers: Operations, Packaging, Production Planning, Quality, and Inventory Control.

Duties and Responsibilities:

• 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.
• Review and verification of raw material supplier documentation and release to inventory.
• Assist in pulling and maintaining QA retains.
• Perform temperature monitoring of QA Freezers.
• Perform other related duties and assignments as required

Education and Experience:

• High School Diploma or equivalent.
• AS degree or college level science courses helpful.
• Experience in Inspection in a biotech or pharma business, other quality assurance experience in biotech or pharma, manufacturing experience in biotech/pharma.
• Experience using SAP or similar enterprise systems.
• General office, computer data entry, zero to three years of experience.

Knowledge, Skills and Abilities:

• Computer Literacy.
• 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 knowledge preferred.
• Requires organizational skills and the ability to follow verbal and written instructions.

Physical Demands:

• 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 – San Diego facilities.

Interview:

• In person/onsite interviews.