Associate QC Micro (247)
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Job Location:
Monthly Salary:
Posted on:
Yesterday
Vacancies:
1 Vacancy
Job Summary
Career Category
QualityJob Description
This role will support manufacturing operations on a 24/7 shift pattern and may include extended hours.
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
- Water sampling
- Testing of In Process samples such as pH
- Initiate and/or implement changes in controlled documents.
- Participate in audits initiatives and projects that may be departmental or organizational in scope.
Basic Qualifications
- Bachelors 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.
Required Experience:
IC
About Company
Amgen, a biotechnology pioneer, discovers, develops and delivers innovative human therapeutics. Our medicines have helped millions of patients in the fight against cancer, kidney disease, rheumatoid arthritis and other serious illnesses. As an organization dedicated to improving the ... View more
