QA Inspector II

Becton Dickinson Medical Devices•San Diego, CA

72d•$25 - $39•Onsite

About The Position

We are the makers of possible BD is one of the largest global medical technology companies in the world. Advancing the world of health™ is our Purpose, and it’s no small feat. It takes the imagination and passion of all of us—from design and engineering to the manufacturing and marketing of our billions of MedTech products per year—to look at the impossible and find transformative solutions that turn dreams into possibilities. We believe that the human element, across our global teams, is what allows us to continually evolve. Join us and discover an environment in which you’ll be supported to learn, grow and become your best self. Become a maker of possible with us. Quality associates support the development and implementation of programs to establish and maintain quality standards of existing products and services, as well as developing programs to focus employees on quality improvement. They support the development of policies, procedures, and methods to check product, material, components and/or operational quality and improve same. They are responsible for supporting the development and implementation of a compliant and cost-effective quality system that assures products and services are reliable, safe and effective. The QA Inspector I I will also be responsible for supporting external customers as well as internal customers, such as Operations, Packaging, Production Planning, Technical Product Managers, and Inventory Control. This role is 100% onsite. Routine work hours will be 10AM-6:30PM, Monday through Friday.

Requirements

Attentive to details, able to handle uncertainty, collaborative, and able to work independently 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.
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.
High School Diploma or equivalent.
2 to 3 years’ experience in General office, computer data entry, QA inspection experience in manufacturing industries, medical device, pharma or biotech field.

Nice To Haves

SAP knowledge preferred.
College degree or college level science courses helpful.
ISO 13485 preferred

Responsibilities

Perform Line Clearance during the production process
P erform 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.
QA inspection of bottled products and kits/sets.
SAP Data Entry.
Review and verif y the completion of batch records and release products to Finished Goods Inventory.
Review and verify raw material supplier documentation and release to inventory
Assist in pulling and maintaining QA retains
Oversee company record archival system. This may include scanning records into company archival system, maintaining the archival box database, supporting cross-functional teams with archival process, etc.
Manage temperature monitoring for all QA freezers
Create and update Quality Notifications for process and product deviations or variance
Work with QEs and/or R&D Program Managers to ensure timely release of FGIs or timely new product launch
Perform other related duties and assignments as required.