JobWatch

29 days old

Quality Document Control Specialist

Kelly Services
Evanston, IL 60201
**Kelly Services is actively recruiting for a Quality Document Control Specialist for a Temp to Hire opportunity in Greater Chicago area, IL.**


_Hybrid Work Schedule - 3-4 days a week remote_


**Responsibilities:**


1. Engineering and Scientific document assembly, change control and Document Control Library archival.

2. Maintenance and continuous improvement of current initially targeted Emergency Use Authorization (EUA) QMS, and expansion to full cGMP compliance.

3. MQA (Manufacturing Quality Assurance), Document Control and finished DHR (Device History Record) GMP/GDP compliance.

4. Daily interaction and documentation & compliance support to internal & external engineering, research & development, manufacturing operations, materials management, program management, and quality individuals and groups.

5. Evaluation and retention of Batch Records and Device History Records for GMP compliance.

6. Identifies results of testing and proposes nonconformance and implementation of CAPA.

7. Write/update QMS Elements, procedures, processes, forms and templates. for R&D, Engineering, Manufacturing Operations, Materials training for the QA/QC and MQA/Document Control practices.

8. Assists in the periodic inspection of laboratory and manufacturing areas, to assure that they are operated and administered according to GMP/GLP and safety requirements.

9. Lead projects related to QA/QC efficiency and improvement.

10. Create, maintain and report out on metrics for tracking and trending the performance of the QMS.

11. Evaluate adverse trends and lead cross functional efforts for corrections

12. Support regulatory, customer, internal and, notified body audits

13. Lead effort to transfer QMS from essentially a manual, shared drive configuration to a specialized medical device enterprise management system.

14. All additional duties as directed and required by the Director Quality.


**Qualifications:**

BS (science or engineering preferred) with 4+ years of experience in medical device or pharmaceutical industry preferred, i.e., FDA 21 CFR 210-211-820/ or ISO 13485 experience.

Experience with GXP (GMP and GDP) regulated production processes.

Demonstrated skills to deal effectively with all team members and colleagues in a very flat organization. The ability to collaboration and roll up ones sleeves to get involved is a must.

Excellent problem-solving skills and ability to effectively use tools associated with ensuring product quality including calipers, micrometer, depth micrometer, indicators, gage pins, gage blocks, height and pin gages, coordinate measurement machine (CMM) or precision optical equipment.


If you feel you have the knowledge and expertise, apply today to connect with a Kelly professional who will work to enrich your life.


\#TJP2022_SPEC


**You should know:** Your safety matters! Vaccination against COVID-19 may be a requirement for this job in compliance with current client and governmental policies. A Kelly recruiter will confirm and share more details with you during the interview process.


**Why Kelly** **** **?**


Kelly Science & Clinical is your connection to premier scientific and clinical companies looking to hire talented people just like you. Every day, we match science professionals with dream jobs that fit their skills and interestsits the way we think job searching should be. Nearly 100 percent of our science recruiters have a professional background/education in science, so we know a thing or two about the science market and how to get you noticed.


**About Kelly** ****


At Kelly, were always thinking about whats next and advising job seekers on new ways of working to reach their full potential. In fact, were 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, including, but not limited to, minorities, females, individuals with disabilities, protected veterans, sexual orientation, gender identity. Equal Employment Opportunity is The Law. (https://www.dol.gov/ofccp/regs/compliance/posters/ofccpost.htm)
Posted: 2022-04-25 Expires: 2022-05-26

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Quality Document Control Specialist

Kelly Services
Evanston, IL 60201

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