Quality Assurance Inspector I - Urgent Need

Position : QA Inspector I

Location : San Diego, CA

Duration : 6 Months

Total Hours/week : 40.00

1st Shift

Client : Medical Devices Company

Job Category : Quality

Level of Experience : Entry Level

Employment Type : Contract on W2 (Need US Citizens or GC Holders or GC EAD or OPT or EAD or CPT

M-F; 9am-5:30pm

JOB DESCRIPTION

• High School diploma or higher ed is required, this is considered entry level.
• Nice to haves (in descending order): experience in Inspection in a biotech or pharma business, other quality assurance experience in biotech or pharma, manufacturing experience in biotech/pharma
• 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

MINIMUM QUALIFICATIONS

KNOWLEDGE AND SKILLS

• 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.
• 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.

EDUCATION AND EXPERIENCE

• High School Diploma or equivalent. AS degree or college level science courses helpful.
• General office, computer data entry, zero to three years QA inspection experience.