Senior Associate QC - Microbiology

Senior Associate QC - Microbiology

Amgen

Dun Laoghaire, Ireland

Specific Job Duties:

• Environmental Monitoring of Grade 8/9 Cleanrooms;
• Environmental Monitoring of Grade 5/7 Cleanrooms & Isolators;
• Reading of Environmental Monitoring Plates;
• Bioburden testing of water & disinfectants;
• Writing technical reports;
• Water sampling;
• Testing of In Process samples such as Protein Concentration, Density & pH;
• 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;
• Introduce new techniques to the lab, including method transfers, reports, validations and protocols;
• Evaluate lab practices for compliance and operational excellence improvement on a continuous basis.
• Approve lab results.

Basic Qualifications:

• Bachelor's degree in a science discipline;
• Biopharmaceutical QC experience in a microbiology lab;
• Experience with regulatory compliance in cGMP manufacturing and testing of pharmaceutical products.

Preferred Qualifications:

• Experience working in an aseptic cleanroom performing Environmental Monitoring;
• Proficient in the use of LIMS & LMES;
• Knowledge of related regulatory/industry considerations, compliance issues and/or scientific discovery;
• Biopharmaceutical QC experience in a microbiology lab;
• Experience with regulatory compliance in cGMP manufacturing and testing of pharmaceutical products.

Competencies:

• Technically strong background in microbiology and aseptic manufacturing;
• Experience in LIMS, Change Control, Trackwise, SAP and CDOCS an advantage;
• Flexibility – the EM role often encounters changing priorities on a daily basis;
• Problem solving skills;
• Experience with Regulatory inspectors and interacting with inspectors desirable;
• 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;
• 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;
• Auditing documentation and operation process;
• Demonstrated ability to interact with regulatory agencies.

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