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QC Analyst, Microbiology - 2nd Shift Job

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Location: Phoenix, AZ Posted Date: 5/3/2013 Position Type: Full time Job Code: hec.1404277 Required Education: Bachelors Degree

Description

Job Title:
Job ID: 14007
Location: Phoenix, AZ
Offsite Territory:
Full/Part Time: Full-Time
Regular/Temporary: Regular
Category: Quality Ops
Department: Quality Control - 1103

Celgene Corporation is committed to delivering innovative therapies designed to improve the lives of patients worldwide. We are a global biopharmaceutical company with operations in more than 70 countries that is helping to turn incurable cancers into chronic, manageable conditions. We are seeking talented professionals as we continue to grow and advance our efforts in oncology, hematology and immune and inflammatory disease. If you would like to join a company where you can make a difference, please consider the Celgene family.

EDUCATION/EXPERIENCE REQUIREMENTS

- Requires a Bachelor's degree in Microbiology or related science from an accredited college or university with a minimum of 4 - 7 years related experience in a regulated laboratory, preferably in a pharmaceutical laboratory environment.
- An equivalent combination of education, experience and training may substitute.

POSITION SUMMARY

The Analyst, Microbiology works both independently and with the team to perform routine and non-routine microbiological testing and Microbiology laboratory maintenance functions.

ESSENTIAL FUNCTIONS

- Carry out responsibilities in accordance with the organization's policies, procedures, and state, federal and local laws.
- Ensure compliance with current Good Manufacturing Procedures (cGMP), USP, EU and other regulatory requirements at all times.
- Collect and test purified water samples from water and steam ports used to support and manufacture drug products.
- Collect environmental samples for particulate and microbiological analysis and provides support for media fills.
- Prepare media used in the microbiological testing of bulk pharmaceutical raw materials, In Process and Finished product.
- Perform routine Microbiological Testing such as Bioburden, Bacterial Endotoxin, and Sterility Testing on water, bulk pharmaceutical raw materials, In process and Finished drug products.
- Perform Quality Control program for laboratory reagents, media, and biological indicator programs.
- Under the guidance of Supervision supports special project work.
- Support testing (Biological Indicator and BET) for the Validation Department Depyrogenation and Sterilization qualification/ validation protocols of the manufacturing equipment.
- Perform microbial identifications.
- Review data generated by other Microbiologists, trains and mentors other Microbiologists.
- Revise and drafts new Standard Operating Procedures (SOPs) for the Microbiology laboratory
- Prepare written monthly reports, data, protocol, summary, document change and investigational reports.
- Record and interprets data results.
- Perform other duties as assigned.

Celgene is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status.

Celgene complies with all applicable national, state and local laws governing nondiscrimination in employment as well as employment eligibility verification requirements of the Immigration and Nationality Act. All applicants must have authorization to work for Celgene in the U.S.

Employment applicants requiring immigration sponsorship must disclose, when initial application for employment is made, whether or not they are legally authorized to work in the U.S. and, if so, whether that authorization permits them to work in the job they seek. In no case should Celgene support of a potential employee's temporary visa application be construed to guarantee success of that application or amend or otherwise invalidate the at-will employment relationship between the employee and Celgene.

Requirements

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