Greiner Bio-One Americas
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Change Control Specialist
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Greiner Bio-One Americas 2 weeks ago Be among the first 25 applicants Join to apply for the
Change Control Specialist
role at
Greiner Bio-One Americas Get AI-powered advice on this job and more exclusive features. Lead and facilitate change control processes, including initiation, evaluation, approval, and documentation of changes to product specifications, manufacturing processes, and controlled documents. Oversee the Change Control Board (CCB) activities, ensuring thorough review and decision-making regarding change risks, impacts, and action plans. Collaborate with cross-functional teams, including Quality, Regulatory, Manufacturing, and R&D, to ensure change controls are well-documented, traceable, and compliant. Product and Process Changes: Assess product and process change proposals to determine compliance with ISO 13485, FDA QSR (21 CFR Part 820), and other applicable regulatory requirements. Facilitate risk assessments and root cause analyses for product or process changes, ensuring controls and mitigations are in place to maintain product integrity. Work closely with operations teams to implement changes and monitor post-implementation to confirm effectiveness and stability. Document Control and eQMS Administration: Manage and Oversee document control processes within the electronic Quality Management System (eQMS), ensuring all controlled documents are current, accessible, and aligned with internal and external standards. Manage document version control and maintain documentation workflows for all changes, including SOPs, technical files, and specifications. Support the administration of eQMS access, authorizations, and training to ensure appropriate and secure document handling across the organization. Manage the verification and implementation process of source documents from GBO Centers in cooperation with the departments in charge. Manages filing of documents and records according to policies and regulatory standards. Training and Guidance: Provide training and mentorship to team members and departments on change control procedures, risk assessment, and compliance requirements. Facilitate regular workshops or refresher sessions to keep stakeholders informed of updates in change control best practices and eQMS functionalities.
Your challenge
Change Control Management: Lead and facilitate change control processes, including initiation, evaluation, approval, and documentation of changes to product specifications, manufacturing processes, and controlled documents. Oversee the Change Control Board (CCB) activities, ensuring thorough review and decision-making regarding change risks, impacts, and action plans. Collaborate with cross-functional teams, including Quality, Regulatory, Manufacturing, and R&D, to ensure change controls are well-documented, traceable, and compliant. Product and Process Changes: Assess product and process change proposals to determine compliance with ISO 13485, FDA QSR (21 CFR Part 820), and other applicable regulatory requirements. Facilitate risk assessments and root cause analyses for product or process changes, ensuring controls and mitigations are in place to maintain product integrity. Work closely with operations teams to implement changes and monitor post-implementation to confirm effectiveness and stability. Document Control and eQMS Administration: Manage and Oversee document control processes within the electronic Quality Management System (eQMS), ensuring all controlled documents are current, accessible, and aligned with internal and external standards. Manage document version control and maintain documentation workflows for all changes, including SOPs, technical files, and specifications. Support the administration of eQMS access, authorizations, and training to ensure appropriate and secure document handling across the organization. Manage the verification and implementation process of source documents from GBO Centers in cooperation with the departments in charge. Manages filing of documents and records according to policies and regulatory standards. Training and Guidance: Provide training and mentorship to team members and departments on change control procedures, risk assessment, and compliance requirements. Facilitate regular workshops or refresher sessions to keep stakeholders informed of updates in change control best practices and eQMS functionalities.
Your Profile
Bachelor’s degree in Life Sciences, Engineering, or a related field. 3+ years of experience in change control within a regulated environment, ideally in medical devices or pharmaceuticals. Strong knowledge of FDA QSR, ISO 13485, and cGMP requirements. Experience with electronic Quality Management Systems (eQMS) and document control.
Our Offer
Seniority level
Seniority level Mid-Senior level Employment type
Employment type Full-time Job function
Job function Other Industries Medical Equipment Manufacturing Referrals increase your chances of interviewing at Greiner Bio-One Americas by 2x Sign in to set job alerts for “Control Specialist” roles.
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Change Control Specialist
role at
Greiner Bio-One Americas 2 weeks ago Be among the first 25 applicants Join to apply for the
Change Control Specialist
role at
Greiner Bio-One Americas Get AI-powered advice on this job and more exclusive features. Lead and facilitate change control processes, including initiation, evaluation, approval, and documentation of changes to product specifications, manufacturing processes, and controlled documents. Oversee the Change Control Board (CCB) activities, ensuring thorough review and decision-making regarding change risks, impacts, and action plans. Collaborate with cross-functional teams, including Quality, Regulatory, Manufacturing, and R&D, to ensure change controls are well-documented, traceable, and compliant. Product and Process Changes: Assess product and process change proposals to determine compliance with ISO 13485, FDA QSR (21 CFR Part 820), and other applicable regulatory requirements. Facilitate risk assessments and root cause analyses for product or process changes, ensuring controls and mitigations are in place to maintain product integrity. Work closely with operations teams to implement changes and monitor post-implementation to confirm effectiveness and stability. Document Control and eQMS Administration: Manage and Oversee document control processes within the electronic Quality Management System (eQMS), ensuring all controlled documents are current, accessible, and aligned with internal and external standards. Manage document version control and maintain documentation workflows for all changes, including SOPs, technical files, and specifications. Support the administration of eQMS access, authorizations, and training to ensure appropriate and secure document handling across the organization. Manage the verification and implementation process of source documents from GBO Centers in cooperation with the departments in charge. Manages filing of documents and records according to policies and regulatory standards. Training and Guidance: Provide training and mentorship to team members and departments on change control procedures, risk assessment, and compliance requirements. Facilitate regular workshops or refresher sessions to keep stakeholders informed of updates in change control best practices and eQMS functionalities.
Your challenge
Change Control Management: Lead and facilitate change control processes, including initiation, evaluation, approval, and documentation of changes to product specifications, manufacturing processes, and controlled documents. Oversee the Change Control Board (CCB) activities, ensuring thorough review and decision-making regarding change risks, impacts, and action plans. Collaborate with cross-functional teams, including Quality, Regulatory, Manufacturing, and R&D, to ensure change controls are well-documented, traceable, and compliant. Product and Process Changes: Assess product and process change proposals to determine compliance with ISO 13485, FDA QSR (21 CFR Part 820), and other applicable regulatory requirements. Facilitate risk assessments and root cause analyses for product or process changes, ensuring controls and mitigations are in place to maintain product integrity. Work closely with operations teams to implement changes and monitor post-implementation to confirm effectiveness and stability. Document Control and eQMS Administration: Manage and Oversee document control processes within the electronic Quality Management System (eQMS), ensuring all controlled documents are current, accessible, and aligned with internal and external standards. Manage document version control and maintain documentation workflows for all changes, including SOPs, technical files, and specifications. Support the administration of eQMS access, authorizations, and training to ensure appropriate and secure document handling across the organization. Manage the verification and implementation process of source documents from GBO Centers in cooperation with the departments in charge. Manages filing of documents and records according to policies and regulatory standards. Training and Guidance: Provide training and mentorship to team members and departments on change control procedures, risk assessment, and compliance requirements. Facilitate regular workshops or refresher sessions to keep stakeholders informed of updates in change control best practices and eQMS functionalities.
Your Profile
Bachelor’s degree in Life Sciences, Engineering, or a related field. 3+ years of experience in change control within a regulated environment, ideally in medical devices or pharmaceuticals. Strong knowledge of FDA QSR, ISO 13485, and cGMP requirements. Experience with electronic Quality Management Systems (eQMS) and document control.
Our Offer
Seniority level
Seniority level Mid-Senior level Employment type
Employment type Full-time Job function
Job function Other Industries Medical Equipment Manufacturing Referrals increase your chances of interviewing at Greiner Bio-One Americas by 2x Sign in to set job alerts for “Control Specialist” roles.
Lead BAS/HVAC Controls Service Technician - Relocation to Tampa with Assistance!
Charlotte, NC $90,000.00-$120,000.00 1 week ago Charlotte, NC $65,000.00-$75,000.00 2 weeks ago Charlotte, NC $65,000.00-$75,000.00 19 hours ago Governance & Control Specialist - Insider Fraud
Charlotte, NC $86,840.00-$130,000.00 1 week ago Charlotte, NC $60,000.00-$90,000.00 3 days ago Charlotte, NC $60,000.00-$75,000.00 2 weeks ago Compliance and Risk Specialist, Third Party Regulatory Oversight, Issue Management, Risk and Controls
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