QA Inspector II

Description

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 II 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.

DUTIES AND RESPONSIBILITIES :

Perform Line Clearance during the production process

Perform 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 verify 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 toensure timely release of FGIs or timely new product launch.

Perform other related duties and assignments as required.

KNOWLEDGE AND SKILLS :

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.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.

EDUCATION AND EXPERIENCE :

High School Diploma or equivalent. College degree or college level science courses helpful.

2 to 3 years’ experience in General office, computer data entry, QA inspection experience in manufacturing industries, medical device, pharma or biotech field.

ISO 13485 preferred

At BD, we prioritize on-site collaboration because we believe it fosters creativity, innovation, and effective problem-solving, which are essential in the fast-paced healthcare industry. For most roles, we require a minimum of 4 days of in-office presence per week to maintain our culture of excellence and ensure smooth operations, while also recognizing the importance of flexibility and work-life balance. Remote or field-based positions will have different workplace arrangements which will be indicated in the job posting.

For certain roles at BD, employment is contingent upon the Company’s receipt of sufficient proof that you are fully vaccinated against COVID-19. In some locations, testing for COVID-19 may be available and / or required. Consistent with BD’s Workplace Accommodations Policy, requests for accommodation will be considered pursuant to applicable law.

Why Join Us?

A career at BD means being part of a team that values your opinions and contributions and that encourages you to bring your authentic self to work. It’s also a place where we help each other be great, we do what’s right, we hold each other accountable, and learn and improve every day.

To find purpose in the possibilities, we need people who can see the bigger picture, who understand the human story that underpins everything we do. We welcome people with the imagination and drive to help us reinvent the future of health.