QA Document Specialist-$19-24

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Job description

**_Kelly Services is now hiring for a Premier Manufacturing company in Cleveland, OH for a QA Document Specialist_**

They are located southeast of Cleveland - right in between Garfield Heights/Maple Heights & Warrensville Heights, off of I-480, between Broadway Ave & Lee Road:

Hours will be 8am-5pm Monday thru Friday

. Pay $40-50k. once hired, eligible for up to 5% bonus. Interview process: MS Teams for 1st interview, then onsite. Hybrid work schedule till Covid is resolved. Initially will work onsite while training, though, before going to hybrid.

The QA Document Specialist is responsible for handling and reporting complaints, issuing device history records, maintaining all current Good Manufacturing (cGMP) documentation and other miscellaneous duties as assigned by Sr. Manager of Regulatory and Quality.

Essential Functions

1. Maintain both computerized and hard copy document systems including documents, procedures and specifications under document control, Device History Records, CAPAs, Nonconformances, etc.

2. Review documents submitted for approval routing to ensure correct formatting, pagination, headers, attachments, forms, etc.

3. Responsible for maintaining the database of electronic attachment/forms of effective documents that are used by employees for the collection for quality data.

4. Responsible for updating and maintaining the database of all Standard Operating Procedures (SOP's), Specifications (SPEC's), Test Methods, Protocols and Validation documentation. This includes converting all documentation to PDF format.

5. Responsible for addressing customer complaints, maintaining hard copy and computer records of complaints, and replacing defective products from the complaint handling process.

6. Responsible for product investigations of defective returned goods and customer complaints.

7. Assist with trend analysis of customer complaints.

8. Responsible for printing and issuing all product Device History Records (DHRs) and review of completed DHRs.

9. Responsible for releasing all finished product lots.

10. Assist with reviewing and developing Quality Assurance documentation.

11. Responsible for organizing the Quality Assurance documentation files.

12. Maintain training records.

13. Maintain Approved Supplier List (ASL).

14. Maintain applicable Board of Pharmacy Licenses.

15. Perform monitoring of the internet for appropriate sale of products.

16. Monitor hazardous waste accumulation area.

17. Serve as a back-up for finished product (QA) testing as well as line clearances during production.

18. Assist with verification of Installation Qualifications (IQ) and Operational Qualifications (OQ) activities.

**Skills Requirements Needed-**

• 1-3 yrs of admin experience for a manufacturing type environment

• Associates degree preferred - but will consider HS Diploma with appropriate experience.

• Knowledge of cGMPs in the Medical Device and/or Pharmaceutical industry a plus

• Proficient in Word/Excel

• Great organizational skills a MUST HAVE

• Document support for all areas of the facility,(engineering, quality, mfg, etc)

• Routing of technical docs, tracking/trending of data, maintaining training program for personnel, device history review

• Handling customers complaints

If interested please send resume to Joe at

**Why Kelly** **®** **?**

You're looking to keep your career moving onward and upward, and we're here to help you do just that. Our financial staffing experts will connect you with premier companies for opportunities where you can learn, grow, and thrive. Jobs that fit your skills and experience, and most importantly, fit right on your path of where you want to go in in your career. It all adds up.

**About Kelly** **®**

At Kelly, we're always thinking about what's next and advising job seekers on new ways of working to reach their full potential. In fact, we're a leading advocate for temporary/nontraditional workstyles, because we believe they allow flexibility and tremendous growth opportunities that enable a better way to work and live (plus, did we mention we provide a ton of benefits ?). Connecting great people with great companies is what we do best, and our employment opportunities span a wide variety of workstyles, skill levels, and industries around the world.

Kelly is an equal opportunity employer committed to employing a diverse workforce and providing accommodations for people with disabilities in all parts of the hiring process as required under its Employment Accommodation Policy. Kelly will work with applicants to meet accommodation needs that are made known to Kelly in advance.