Are you a QC with over 5 years experience? Are you familiar with the principles, concepts, theories and standards of GMP QC analytical laboratories? If you have the relevant experience, send your CV to karen@jobcontax.com or call (01)7978720 for a confidential chat.
QC - Sample Management - Amgen
Employer
Our Client is Amgen and the role will be based in their Dun Laoghaire plant. The plant is one of the most dynamic in Ireland and is currently undergoing rapid expansion and capital investment.
Job Description:
Primary Responsibilities, Accountabilities and Decisions Rights
• Manage all sample management activities throughout the site
• Create/own and approve protocols, sample plans, SOP and documentation
• Site ownership of stability programme
• Responsible for SAP and LIMS functions/ transactions within the sample management remit
• Site ownership of Reference standards and reserves
• Out of hours responder for sample management equipment (fridges /freezers / incubators)
• Responsible for their own training and safety compliance.
• Sample shippments and temperature monitoring activities.
Job Summary:
Under minimal supervision, responsible for one or more of the following activities in QC including sample and data management and equipment maintenance.
• Contributes to team by ensuring the quality of the tasks/services provided by self
• Contributes to the completion of milestones associated with specific projects or activities within team
This role will support QC and manufactruing operations, as such some extended hours and weekend work flexibility may be necessary as required.
Specific Job Duties:
• Perform routine sample management procedures.
• With a high degree of technical flexibility, work across diverse areas within the lab
• Plan and perform routine tasks with efficiency and accuracy.
• Plan and perform multiple, complex routine/ non-routine methods and procedures and a large variety of tasks.
• Report, evaluate, back-up/archive, trend and approve data.
• Troubleshoot, solve problems and communicate with stakeholders.
• Initiate and/or implement changes in controlled documents.
• Participate in audits, initiatives, and projects that may be departmental or organizational in scope.
• Write protocols and perform validation and equipment qualification/ verification.Operate and maintain specialised equipment.
• Introduce new techniques to the area, where appropriate.
• Evaluate sample management practices for compliance and operational excellence improvement on a continuous basis.
• Approve results where applicable
• May participate in lab investigations.
• May provide technical guidance.
• May train others.
• May contribute to regulatory filings.
• May represent the department/organization on various teams
• May interact with outside resources.
• Perform general housekeeping in all sample management areas.
Requirements
• Bachelor’s degree in a Science related field is required.
• 5+ years of biopharmaceutical QC experience or related quality control or GMP laboratory experience in the pharmaceutical or medical device industry.
• Experience with regulatory compliance in cGMP manufacturing and testing of pharmaceutical products.
Profile:
• Take initiative to identify and drive improvements
• Communication skills (verbal and written) at all levels
a. Strong Technical writing skills for GMP documentation (e.g. investigations, procedures, change controls)
b. Presentation skills
c. Escalate issues professionally and on a timely basis
• Decision Making skills
• Teamwork and Coaching others
• Negotiation and Influence skills
• Investigation skills
• Problem solving skills
a. Applies research, information gathering, analytical, and interpretation skills to problems of diverse scope
i. Ensures compliance within regulatory environment
ii. Develops solutions to technical problems of moderate complexity
iii. Screens, categorizes, evaluates, reconciles, reports, and resolves data integrity issues
b. Interprets generally defined practices and methods
c. Able to use statistical analysis tools to perform data trending and evaluation
• Project Management and organizational skills, including ability to follow assignments through to completion
Compentencies:
• Demonstrated ability to work independently and deliver right first time results
a. Works under minimal direction
b. Work is guided by objectives of the department or assignment
i. Follows procedures
ii. Refers to technical standards, principles, theories and precedents as needed
iii. May set project timeframes and priorities based on project objectives and ongoing assignments
iv. Recognizes and escalates problems
• Working knowledge of aseptic compliance within the manufacturing environment and demonstrated leadership and communication skills to communicate requirements to collegues
• Auditing documentation and operation process
• Demonstrated ability to interact with regulatory agencies
Package:
Minimum 12 month contract
Rate: €35 - €43 per hour
Contact
Karen McHugh is the consultant managing this position. If you have any queries about this role, you can contact her by e-mail karen@jobcontax.com or phone +353-1 7978720
Click to connect with Karen on LinkedIn
Similar Jobs
Jobs in Dublin
Amgen Jobs
Are you a QC with over 5 years experience? Are you familiar with the principles, concepts, theories and standards of GMP QC analytical laboratories? If you have the relevant experience, send your CV to karen@jobcontax.com or call (01)7978720 for a confidential chat.
QC - Sample Management - Amgen
Employer
Our Client is Amgen and the role will be based in their Dun Laoghaire plant. The plant is one of the most dynamic in Ireland and is currently undergoing rapid expansion and capital investment.
Job Description:
Primary Responsibilities, Accountabilities and Decisions Rights
• Manage all sample management activities throughout the site
• Create/own and approve protocols, sample plans, SOP and documentation
• Site ownership of stability programme
• Responsible for SAP and LIMS functions/ transactions within the sample management remit
• Site ownership of Reference standards and reserves
• Out of hours responder for sample management equipment (fridges /freezers / incubators)
• Responsible for their own training and safety compliance.
• Sample shippments and temperature monitoring activities.
Job Summary:
Under minimal supervision, responsible for one or more of the following activities in QC including sample and data management and equipment maintenance.
• Contributes to team by ensuring the quality of the tasks/services provided by self
• Contributes to the completion of milestones associated with specific projects or activities within team
This role will support QC and manufactruing operations, as such some extended hours and weekend work flexibility may be necessary as required.
Specific Job Duties:
• Perform routine sample management procedures.
• With a high degree of technical flexibility, work across diverse areas within the lab
• Plan and perform routine tasks with efficiency and accuracy.
• Plan and perform multiple, complex routine/ non-routine methods and procedures and a large variety of tasks.
• Report, evaluate, back-up/archive, trend and approve data.
• Troubleshoot, solve problems and communicate with stakeholders.
• Initiate and/or implement changes in controlled documents.
• Participate in audits, initiatives, and projects that may be departmental or organizational in scope.
• Write protocols and perform validation and equipment qualification/ verification.Operate and maintain specialised equipment.
• Introduce new techniques to the area, where appropriate.
• Evaluate sample management practices for compliance and operational excellence improvement on a continuous basis.
• Approve results where applicable
• May participate in lab investigations.
• May provide technical guidance.
• May train others.
• May contribute to regulatory filings.
• May represent the department/organization on various teams
• May interact with outside resources.
• Perform general housekeeping in all sample management areas.
Requirements
• Bachelor’s degree in a Science related field is required.
• 5+ years of biopharmaceutical QC experience or related quality control or GMP laboratory experience in the pharmaceutical or medical device industry.
• Experience with regulatory compliance in cGMP manufacturing and testing of pharmaceutical products.
Profile:
• Take initiative to identify and drive improvements
• Communication skills (verbal and written) at all levels
a. Strong Technical writing skills for GMP documentation (e.g. investigations, procedures, change controls)
b. Presentation skills
c. Escalate issues professionally and on a timely basis
• Decision Making skills
• Teamwork and Coaching others
• Negotiation and Influence skills
• Investigation skills
• Problem solving skills
a. Applies research, information gathering, analytical, and interpretation skills to problems of diverse scope
i. Ensures compliance within regulatory environment
ii. Develops solutions to technical problems of moderate complexity
iii. Screens, categorizes, evaluates, reconciles, reports, and resolves data integrity issues
b. Interprets generally defined practices and methods
c. Able to use statistical analysis tools to perform data trending and evaluation
• Project Management and organizational skills, including ability to follow assignments through to completion
Compentencies:
• Demonstrated ability to work independently and deliver right first time results
a. Works under minimal direction
b. Work is guided by objectives of the department or assignment
i. Follows procedures
ii. Refers to technical standards, principles, theories and precedents as needed
iii. May set project timeframes and priorities based on project objectives and ongoing assignments
iv. Recognizes and escalates problems
• Working knowledge of aseptic compliance within the manufacturing environment and demonstrated leadership and communication skills to communicate requirements to collegues
• Auditing documentation and operation process
• Demonstrated ability to interact with regulatory agencies
Package:
Minimum 12 month contract
Rate: €35 - €43 per hour
Contact
Karen McHugh is the consultant managing this position. If you have any queries about this role, you can contact her by e-mail karen@jobcontax.com or phone +353-1 7978720
Click to connect with Karen on LinkedIn
Similar Jobs
Jobs in Dublin
Amgen Jobs
We need : English (Good)
Type: Permanent
Payment: package
Category: Pharmaceutical