Position : Quality Assurance Inspector I (Exp in biotech or pharma, manufacturing experience in biotech/pharma) Entry Level
Location : San Diego, CA
Duration : 6 Months
Total Hours/week : 40.00
pay rate: $20-25/hr
1st Shift
Client : Medical Devices Company
Job Category : Quality
Level of Experience : Senior Level
Employment Type : Contract on W2 (Need US Citizens or GC Holders or GC EAD or OPT or EAD or CPT)7
Hours - During training likely 8:30am-5pm; once established, start time will be customized to somewhere between 7am-8:30am (some flexibility…we try to stagger start/end times for the team), end time would be 8.5 hours after start time
• 3 must haves on the resume:
High School diploma or higher ed is the only true requirement…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
Job Description
• 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, Technical Product Managers 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 BD Biosciences - 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.