Sr. Associate Qc

3 days ago

Dublin, Dublin City, Ireland Amgen Inc. (Ir) Full time

Career CategoryQuality
Job DescriptionQuality Control NPI Snr Associate Level 4 Amgen Dun Laoghaire Primary Responsibilities: QC Representative for NPI activities and routine Product meetingsAssist with activities related to QC projects and/or QC tasks within Site projectsPlan and perform non-core testing related to NPI activitiesManage all sample management activities related to NPI activities throughout the siteCreate/own and approve protocols, sample plans, SOP and documentation related to NPIQC Representative responsible for Method Validation and Transfers co-ordination and readinessResponsible for their own training and safety compliance.Sample shipments and temperature monitoring activities for NPI activitiesLIMS data coordination of non-core (NPI) activities.Job Summary:
Under minimal supervision, responsible for one or more of the following activities in QC including analytical testing, characterization, sample and data management.
Contributes to team by ensuring the quality of the tasks/services provided by selfContributes to the completion of milestones associated with specific projects or activities within teamThis role will support QC and manufacturing operations, as such some extended hours and weekend work flexibility may be necessary as required.
Specific Job Duties:

• With a high degree of technical flexibility, work across diverse areas within QC

• Plan and perform analyses with great efficiency and accuracy.

• Plan and perform multiple, complex routine/ non-routine methods and procedures and a large variety of assays.

• Report, evaluate, back-up/archive, trend and approve analytical data.

• Troubleshoot, solve problems and communicate with stakeholders.

• Initiate and/or implement changes in controlled documents.

• May train others as necessary

• Participate in audits, initiatives and projects that may be departmental or organizational in scope.

• Write protocols and perform assay validation and equipment qualification/ verification.

• Introduce new techniques to the lab, including method transfers, reports, validations and protocols.

• May contribute to regulatory filings.

• May conduct lab investigations as necessary.

• Evaluate lab practices for compliance on a continuous basis.

• Approve lab results

• May represent the department/organization on various teams

• May interact with outside resources.

• Create APPX data files and randomisation memo to facilitate data analysis.

• LIMS data coordination of commercial and import testing on site where applicable

• May provide technical guidance.
May contribute to regulatory filings.

• May represent the department/organization on various teams.
May train others.

• May interact with outside resources

Basic Qualifications & Experience: Bachelor's degree in a science discipline.
2-3 years of biopharmaceutical QC experience or related quality control or GMP laboratory experience in the pharmaceutical or medical device industry.Strong background in Chemistry and Analytical testing is required.Experience with regulatory compliance in cGMP manufacturing and testing of pharmaceutical products.Knowledge: Understanding and application of principles, concepts, theories, and standards of GMP QC analytical laboratories.
Deepens technical knowledge through exposure and continuous learningKnowledge of related regulatory/industry considerations, compliance issues and/or scientific discoveryProblem Solving: Applies analytical skills to evaluate and interpret complex situations/ problems using multiple sources of informationQualitative informationQuantitative researchTrend dataAnticipates and prevents potential problemsSkills: Take initiative to identify and drive improvementsCommunication skills (verbal and written) at all levelsStrong Technical writing skills for GMP documentation (e.g.
investigations, procedures, change controls)Presentation skillsEscalate issues professionally and on a timely basisDecision makingTeamwork and Coaching othersAuditing documentation and operation processCompetencies: Demonstrated ability to work independently and deliver right first-time resultsWorks under minimal direction Work is guided by objectives of the department or assignment
Follows procedures
Refers to technical standards, principles, theories, and precedents as needed
May set project timeframes and priorities based on project objectives and ongoing assignments
Recognizes and escalates problems
Working knowledge of aseptic compliance within the manufacturing environment and demonstrated leadership and communication skills to communicate requirements to colleaguesAuditing documentation and operation processDemonstrated ability to interact with regulatory agenciesRelevant experience: Bachelor's degree in a Science related field is required.2-3 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.
About Us
Amgen is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics.
This approach begins by using tools like advanced human genetics to unravel the complexities of disease and understand the fundamentals of human biology.
Amgen focuses on areas of high unmet medical need and leverages its biologics manufacturing expertise to strive for solutions that improve health outcomes and dramatically improve people's lives.
A biotechnology pioneer since 1980, Amgen has grown to be one of the world's leading independent biotechnology companies, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential.

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