Sr Associate QC Microbiology (247 Shift)
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Job Location:
Monthly Salary:
Posted on:
20 hours ago
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
- Writing technical reports
- Water sampling
- Testing of In Process samples such as 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
- 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
- Minimum three years Biopharmaceutical QC experience in a microbiology lab working as part of an Environmental Monitoring team who directly support manufacturing in a Grade A/B area
- 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:
Senior IC
Key Skills
- Aeronautical
- Healthcare Attorney
- Fitness
- General Services
- Account Management
- Export Documentation
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
