Amgen Sr Associate Quality Control CAS (Chemistry) in Dun-Laoghaire-Rathdown, Ireland
Under minimal supervision, responsible for one or more of the following activities in QC including analytical testing of EU Release, Commercial, Stability, Utilities, raw materials and Validation.
- Contributes to team by ensuring the quality of the tasks/services provided by self
Extended hours and weekend work flexibility may be necessary as required.
Specific Job Duties:
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.
Participate in audits, initiatives and projects that may be departmental or organizational in scope.
Review protocols and perform assay validation and equipment qualification/ verifications when required.
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 interact with outside resources.
LIMS data coordination of commercial and import testing on site where applicable
May represent the department/organization on various teams. May train others.
Primary knowledge, skills, competencies and relevant experience
Understanding and application of principles, concepts, theories and standards of GMP QC analytical laboratories. Deepens technical knowledge through exposure and continuous learning
Knowledge of related regulatory/industry considerations, compliance issues and/or scientific discovery
Communication 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 basis
Decision Making skills
Teamwork and Coaching others
Negotiation and Influence skills
Problem solving skillsApplies research, information gathering, analytical, and interpretation skills to problems of diverse scopeEnsures compliance within regulatory environmentDevelops solutions to technical problems of moderate complexityScreens, categorizes, evaluates, reconciles, reports, and resolves data integrity issuesInterprets generally defined practices and methodsAble to use statistical analysis tools to perform data trending and evaluation
Project Management and organizational skills, including ability to follow assignments through to completion
- Demonstrated ability to work independently and deliver right first time results
Works under minimal direction Work is guided by objectives of the department or assignment
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 colleagues
Auditing documentation and operation process
Demonstrated ability to interact with regulatory agencies
Bachelor's degree in a Science related field is required.
4+ 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.