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QC Microbiologist Analyst IV
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QC Microbiologist Analyst IV : MedImmune, LLC.
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| Job Number |
02158 |
| Employee Type |
Full Time |
| Company Name |
MedImmune, LLC. |
| Location |
Santa Clara
California
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| Salary (year) |
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| Start Date |
1/18/2010 |
| Industry |
Biotech |
| Job Type |
Operations-Quality |
| Relocation |
Not Required |
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MedImmune, LLC.
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| Description |
Description
Title: QC Microbiologist Analyst IV
Location: CA, Santa Clara - NON SALES
Req: 02158
Position Summary:
Major Duties and Responsibilities (including supervising others):
The QC Microbiologist is a hand-on QC laboratory position, contributing to all aspects of a microbiology testing and environmental monitoring laboratory, from general laboratory operations, sampling, and performing testing. The position is also responsible for performing routine microbiological analytical methods development, qualification, and implementation of microbiological analytical methods, including creating and revising SOPs and protocols through a change control documentation system from creation through approval, creating qualification (PQ) protocols, and leading protocol execution and final report. This position will lead QC equipment and facility validation support and manufacture process. In addition, the Microbiologist will conduct investigations of exceptional conditions and other non-conformances, including environmental and utilities monitoring excursions
About the Organization
My company shares my
passion for helping to improve human health around the world."
"This is My MedImmune."
Those who join MedImmune feel a sense of ownership about their future. They thrive with a recognized leader in the biotechnology industry and the wholly-owned subsidiary of AstraZeneca plc.
Here, you will join passionate professionals who advance science, technology and medicine to develop products designed to help people live better lives. You will excel in an environment characterized by respect, integrity and growth opportunities…that encourages both individual contribution and collaborative entrepreneurial thinking. Our products and/or product candidates are designed to address areas of need in infection, oncology, respiratory disease and inflammation, cardiovascular/gastrointestinal disease and neuroscience. Explore a MedImmune career as we strive to better more lives, more often, around the world.
Company Information
MedImmune, LLC. is an Equal Opportunity Employer and does not discriminate on the basis of race, color, religion, gender, age, national origin, disability, veteran status, or any other characteristic protected by federal, state or local law.
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| Requirements |
Position Requirements
The QC Microbiologist is responsible:
• Subject Matter Expert (SME), for microbiological methodologies and environmental monitoring (EM) program for pharmaceutical manufacturing facility producing materials for both commercial distribution and clinical trials.
• Perform microbiological testing for in-process, intermediate, and final product release under applicable regulatory requirements (GMP, GLP, EP)
• QC SOP create/review/approval
• Review QC test records and result and create of trend reports
• Develop analytical method qualification/validation protocols and execution qualification studies, generating appropriate reports.
• Non-conformance, EM and utilities excursion investigations to determine root cause as well as identify and implement appropriate corrective and preventative actions
• Microbiology trainer for site for QC and manufacturing personnel
• Process validation and personnel qualification support
Role of SME for Analytical, Microbiological Items
• Perform routine microbiological methods to support production of Clinical Trial Material (CTM)
• Method optimization/development
• Investigations (Sterility, Bioburden or EM excursions)
Educational Requirements
Requirements/Qualifications:
Education: BS in Microbiology, biological sciences or a related field
Experience: 5-10 years previous biopharmaceutical laboratory experience. Experience in clean room environment validations, ISO Standards, method validation
Special Skills/Abilities: Aseptic and assay training skills. Familiarity with particle counters, air sampler, and equipment and media qualifications. Experience with microbiological sampling, working in a clean room environment. Strong aseptic technique and basic computer skills are needed to perform this job. Strong microbiology knowledge and laboratory analytical skills with good communication and interpersonal skills. cGMP experience and the ability to work independently as well as in a team environment.
Supervision: Works under limited supervision and must be able to work independently. Strong communication, organization, leadership and team building skills
MedImmune does not accept non-solicited resumes or candidate submittals from search/recruiting agencies not already on MedImmune’s approved agency list. Unsolicited resumes or candidate information submitted to MedImmune by search/recruiting agencies not already on MedImmune’s approved agency list shall become the property of MedImmune and if the candidate is subsequently hired by MedImmune, MedImmune shall not owe any fee to the submitting agency.
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