Kaztronix
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Contract Manufacturing Associate
Job Description
Contract Manufacturing Associate
Job Summary
Support Quality activities at Contract Manufacturing Organizations (CMO) by providing timely and effective quality oversight. Accomplish quality objectives by planning and evaluating project activities. Support may include operations and validation.
Area of Responsibility
Review of manufacturing and packaging records
Review certificate of analysis and Certificate of compliance
Ensure the release packages are ready prior to batch disposition
Review of QMS records submitted by CMO and monitoring (e.G. Change controls/deviations, quality agreements but not limited to)
Manage and oversee complaint, change control, and variation-filing modules for CMO activity.
Actively participate in day to day meetings
Participate in the qualification process and support assigned CMO aligned with the Pharma Quality Management Systems and provide reports as required.
Implement, report and monitor CMO Quality Metrics and ensure identification and implementation of improvements needed through routine CMO business review.
Implement and maintain Regional CMO data in the Global CMO database.
Ensure the Quality Assurance Agreements which are created and maintained according to Pharma requirements, are regularly reviewed and followed.
Conduct review and approve batch release documentation.
Support significant quality issues associated with Drug Products or Medical Devices originating from assigned CMO (complaints, deviations, recalls, counterfeits and product tampering, stability failures, etc.) appropriately and in a timely fashion.
Maintain annual auditing program, participate in technical visits and/or audits, manage action plans and follow up on agreed upon CAPAs.
Manage and oversee complaint module for Site.
Office Environment
Lab Environment
Manufacturing Environment
Environmental related to manufacturing/production environments:
JOB REQUIREMENTS:
Travel Up to 10 % Education and Job Qualification
Minimum of a Bachelor s degree in a scientific discipline;MS preferred.
Certified Quality Auditor (e.G. ASQ) certification preferred.
Expert skills related to investigations (e.G. Lean Six Sigma) Quality Agreements, and CMO management.
Ability to identify key priorities necessary for and be able to author/implement global policies and procedures.
Strong understanding of technical pharmaceutical processes as well as risk assessment and risk management fundamentals/tools.
Strong knowledge of cGMP, QA/QC and regulatory compliance (US, EU and other regulatory requirements).
Strong interpersonal and communication, both written and verbal, skills.
Good negotiation and influencing skills.
Operational knowledge of pharmaceutical processing and packaging operations.
Task oriented team plan who is able to manage multiple complex priorities and work in a cross-cultural working environment.
5 years of related experience in a cGMP environment, preferably in a project management capacity for pharmaceutical or biotechnology industries.
Experience in drug product sterile pharmaceutical/biologics manufacturing and QC is an asset.
Job Summary
Support Quality activities at Contract Manufacturing Organizations (CMO) by providing timely and effective quality oversight. Accomplish quality objectives by planning and evaluating project activities. Support may include operations and validation.
Area of Responsibility
Review of manufacturing and packaging records
Review certificate of analysis and Certificate of compliance
Ensure the release packages are ready prior to batch disposition
Review of QMS records submitted by CMO and monitoring (e.G. Change controls/deviations, quality agreements but not limited to)
Manage and oversee complaint, change control, and variation-filing modules for CMO activity.
Actively participate in day to day meetings
Participate in the qualification process and support assigned CMO aligned with the Pharma Quality Management Systems and provide reports as required.
Implement, report and monitor CMO Quality Metrics and ensure identification and implementation of improvements needed through routine CMO business review.
Implement and maintain Regional CMO data in the Global CMO database.
Ensure the Quality Assurance Agreements which are created and maintained according to Pharma requirements, are regularly reviewed and followed.
Conduct review and approve batch release documentation.
Support significant quality issues associated with Drug Products or Medical Devices originating from assigned CMO (complaints, deviations, recalls, counterfeits and product tampering, stability failures, etc.) appropriately and in a timely fashion.
Maintain annual auditing program, participate in technical visits and/or audits, manage action plans and follow up on agreed upon CAPAs.
Manage and oversee complaint module for Site.
Office Environment
Lab Environment
Manufacturing Environment
Environmental related to manufacturing/production environments:
JOB REQUIREMENTS:
Travel Up to 10 % Education and Job Qualification
Minimum of a Bachelor s degree in a scientific discipline;MS preferred.
Certified Quality Auditor (e.G. ASQ) certification preferred.
Expert skills related to investigations (e.G. Lean Six Sigma) Quality Agreements, and CMO management.
Ability to identify key priorities necessary for and be able to author/implement global policies and procedures.
Strong understanding of technical pharmaceutical processes as well as risk assessment and risk management fundamentals/tools.
Strong knowledge of cGMP, QA/QC and regulatory compliance (US, EU and other regulatory requirements).
Strong interpersonal and communication, both written and verbal, skills.
Good negotiation and influencing skills.
Operational knowledge of pharmaceutical processing and packaging operations.
Task oriented team plan who is able to manage multiple complex priorities and work in a cross-cultural working environment.
5 years of related experience in a cGMP environment, preferably in a project management capacity for pharmaceutical or biotechnology industries.
Experience in drug product sterile pharmaceutical/biologics manufacturing and QC is an asset.
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