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We are not offering you a job, but rather we are offering you a workplace that feels like home at Greiner Bio-One.

Product Release Lead

Location: 

Monroe, US, 28110

Travel activity:  N/a
Employment Type:  Permanent

Your challenge

Responsibility: 

Review of Quality Production documentation for each batch  

Evaluate lots for conformance to ISO 13485, ISO 9001, 21 CFR 820, regulatory, and internal requirements 

Verify closure of QIR’s and ensure accuracy of Device History Records (DHRs) 

Coordinate corrections or updates to documentation as needed 

Maintain retention of batch records and QA documentation  

Execute release of medical device and non-regulated products 

Generate Certificates of Conformance (CoC) 

Prioritize lots for release based on input from sales, warehouse, production and QA. 

Communicate release status and delays to warehouse, sales, production, and management as appropriate. 

Escalate issues impacting batch release to QA leadership 

Support internal, customer, ISO, and regulatory audit as needed  

Support investigations and dispositions of nonconforming product  

Assist in reporting QA metrics and KPI’s related to product release  

Participate in CAPAs and corrective action activities when assigned  

Complete require annual GDP/GMP trainings 

Your Profile

Job Requirements: 

High School Diploma (Bachelor’s degree or related field of experience preferred). 

Experience in Clinical Laboratory (working knowledge of CLSI Venipuncture Standards). 

Experience in phlebotomy (ideally on GBO products). 

Excellent computer skills (MS Office). 

Strong selling/persuasive skills. 

Strong communication skills both verbal and written. 

Strong organizational skills. 

50-75% travel required and ability to train using a variety of video platforms (Zoom, Webex, Teams, etc.) 

Field based role. 

Possess and maintain a valid driver’s license with no suspensions or major infractions over the previous five years. An annual MVR will be required on all company authorized drivers. 

Possess and provide documentation that personal motor vehicle insurance coverage is maintained at company specified limits. 

 

 

Physical Requirements: 

Regularly required to stand, sit, reach, bend and move within facilities. 

Light physical effort may be required. 

Ability to physically travel to customer sites with various schedules and possibly different time zones. 

We provide equal opportunities for everyone and see diversity as our strength. Therefore, we welcome all applicants – regardless of identifying characteristics such as gender, age, background, social status, veteran status, sexual orientation, religion, or mental and physical abilities. We have additionally set the goal of empowering women and increasing female leader representation. We foster an inclusive work environment and encourage all individuals to apply.
Job ID:  3685

About Greiner Bio-One

Greiner Bio-One feels like home.

For visionaries with drive and ideas, for team players who share their knowledge and entertain new ways of thinking, for people who strive for excellence. Our door is always open to achievers, doers and hidden talents who want to make a difference.

We have future in our blood.


Nearest Major Market: Charlotte

Apply now »