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Associate Analyst, Quality Control Microbiology (2nd shift)

Company: Celgene
Location: Phoenix
Posted on: November 17, 2019

Job Description:

Req #: 1902976
Location: Phoenix, Arizona, United States
Job Category: Quality
Work Location: 620 N. 51st Avenue 85043
Organization: Quality Control
Shift: 2nd Shift_USA
Employee Status: Full-time
Job Type: Regular
Purpose and Scope of PositionThe Associate Analyst, QC Microbiology, is responsible for routine and non-routine microbiologicaltesting and environmental monitoring in support of sterile product manufacturing. The AssociateAnalyst is also responsible for peer review and support activities in the laboratory to ensure smoothlaboratory operation in accordance with the organization s policies, procedures, and state, federal andlocal laws and ensure compliance with current Good Manufacturing Practices (cGMP), USP, EP, JPand other regulatory requirements at all times.
Required Competencies: Knowledge, Skills, and Abilities Basic proficiency in MS Word, Outlook, and Excel programs. Basic experience with various microbiological testing and environmental monitoring techniques. Basic knowledge of electronic laboratory management systems. Strong attention to detail. Basic organizational skills. Basic knowledge of cGMP, USP, EP, FDA/PDA, OSHA and other regulatory guidance documentsas relates to microbiological testing and environmental monitoring. Basic written and verbal communication skills. Ability to gown and maintain a sterile work environment. Ability to accurately and completely understand and follow SOP, test method and cGMPrequirements; uses good judgement and follows procedures. Basic GMP documentation skills. Knowledge of laboratory safety practices. Ability to pair with mentors for guidance as well as to collaborate with peers on day-to-day tasks;cooperative and works well with a team. Willingness to learn and share knowledge. Communicates effectively with peers, management and cross-functionally across the site. Basic knowledge of laboratory and aseptic processes. Ability to work under regular supervision. Basic critical reasoning and decision-making skills. Ability to pass an initial full physical with annual monitoring. Ability to deal appropriately with regulatory agencies during regulatory and non-regulatoryinspections.
Duties and ResponsibilitiesPerforms routine laboratory and EM activities. Prepares schedules and sample labels. Performs tests such as (but not limited to) bioburden, Growth Promotion, incoming media/reagentQC, BI testing. Operates laboratory equipment used to provide sterile and depyrogenated materials. Read EM and testing plates and assess against alert and action levels as appropriate. Performs microbial isolation techniques, Gram stains and supports microbial identificationprocess. Performs environmental monitoring activities in support of manufacturing. Collects utility samples for analysis. Maintain qualification status on aseptic gowning, etc. Demonstrates aseptic technique when performing a Microbiological Test or EM. Perform testing/monitoring activities associated with protocols or special projects as required. Executes scheduled testing and monitoring activities within the QC lab and manufacturing facility. Communicates appropriately with peers and Laboratory Management regarding scheduledduties. Uses tracking tools as appropriate (EM batch release, sample trackers, etc.) Administrative tasks. Communicate effectively with management regarding more complex issues.
Participate in departmental training initiatives Document training per procedural and cGMP requirements. Actively seeks out opportunities to learn from others within and outside the department. Assist other analysts, freely sharing knowledge and experience. Executes best practices in the laboratory
Perform peer review of testing data Review all data in accordance with applicable procedures and cGMP requirements. Ensure all testing is performed in a compliant matter. Complete all review in accordance with required timelines. Communicate effectively with peers, and demonstrate teamwork, with regards to results of reviewand corrections required.
Performs general laboratory duties as assigned.
Education and Experience High school diploma or equivalent required. Bachelor s Degree, particularly in Microbiology or Science related field, preferred.
0-2 years of Related Experience
GMP Aseptic Manufacturing and/or Laboratory/Clean Room Experience preferred.
An equivalent combination of education / experience may substitute.
Working Conditions The incumbent will be required to wear uniform/ PPE to work in a manufacturing, warehouse, orlaboratory environment. The incumbent may be fully gowned for extended periods of time within a restrictive movementenvironment. This may include standing, bending, reaching, kneeling, etc. The incumbent will have to perform work in a controlled environment with strict glove and gownrequirements. The incumbent will be required to maintain a safety alertness due to work around hazardousequipment and cytotoxic product. This position requires regular medical surveillance and may require incumbent to wear arespirator or gown. The incumbent must be able to distinguish colors and possess correctable vision to 20/20; annualeye exam is required. The incumbent may analyze data and work with spreadsheets and graphs on a daily basis. The incumbent may be working in a laboratory or manufacturing setting up to 6 hours per day. The incumbent must be able to lift/carry not more than 25 pounds.

About Us

COMMITTED TO IMPROVING THE LIVES OF PATIENTS WORLDWIDE

At Celgene, we seek to deliver truly innovative and life-changing drugs for our patients. Our vision as a company is to build a major global biopharmaceutical corporation while focusing on the discovery, the development, and the commercialization of products for the treatment of cancer and other severe, immune, inflammatory conditions.

"At Celgene, we seek to deliver truly innovative and life-changing drugs for our patients."

There are more than 300 clinical trials at major medical centers using compounds from Celgene. Investigational compounds are being studied for patients with incurable hematological and solid tumor cancers, including multiple myeloma, myelodysplastic syndromes, chronic lymphocytic leukemia (CLL), non-Hodgkin s lymphoma (NHL), triple-negative breast cancer and pancreatic cancer. As committed as we are to clinical accomplishment, we are equally committed to patient support, which is a guiding principle at Celgene. We believe all who can benefit from our discoveries should have the opportunity to do so. Celgene puts patients first with industry-leading programs that provide information, support and access to our innovative therapies. Associated topics: aseptic technique, biopharma, dietetic, dietician, drug discovery, histologist, microbiological, nephrology, therapy, virus

Keywords: Celgene, Goodyear , Associate Analyst, Quality Control Microbiology (2nd shift), Professions , Phoenix, Arizona

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