What are the responsibilities and job description for the Product Release Lead position at Greiner Bio-One Americas?
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 characteristics such as gender, age, background, social status, sexual orientation, religion, or mental and physical abilities. We have set the goal of empowering women and increasing female leader representation. We foster an inclusive work environment and encourage all individuals to apply.
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 characteristics such as gender, age, background, social status, sexual orientation, religion, or mental and physical abilities. We have set the goal of empowering women and increasing female leader representation. We foster an inclusive work environment and encourage all individuals to apply.