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Quality Specialist- Biomedical job in San Diego

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San Diego CorTech LLC

Job Ref:  365631
Employer:  CorTech LLC
Job Type:  Contract
Salary and Benefits:  24.50/Per Hour
Remote:  No

Location

City:  San Diego
Post Code:  92121
Map: 

Description

We are seeking a detail-oriented and experienced Quality Assurance Specialist to join our dynamic team within the medical devices industry. This role is critical in ensuring that our products meet the highest standards of quality and safety, adhering to regulatory compliance and industry best practices. As a Quality Assurance Specialist, you will be responsible for maintaining quality assurance protocols to guarantee that our products not only meet but exceed customer expectations. You will work closely with cross-functional teams including engineering, manufacturing, and regulatory affairs to identify potential quality issues and facilitate solutions. Your analytical skills and attention to detail will be essential in evaluating processes and products, conducting audits, and ensuring documentation integrity.

Hours: 8:30am-5pm
Pay rate: $24.50/hr

Medical, Dental, Vision, 401k

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
1. QA inspection of bottled products and kits/sets.

2. SAP Data Entry.

3. Review and verification of completion of batch records and release products to Finished Goods Inventory.

4. Review and verification of raw material supplier documentation and release to inventory.

5. Assist in pulling and maintaining QA retains.

6. Perform temperature monitoring of QA Freezers.

7. Line Clearance for production.

8. 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 may be 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. BD04123JD
ref: (365631)
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