Sr. Analyst, QC Microbiology JobCelgene Corporation - Phoenix, AZ
Celgene is a global biopharmaceutical company leading the way in medical innovation to help patients live longer, better lives. Our purpose as a company is to discover and develop therapies that will change the course of human health. We value our passion for patients, quest for innovation, spirit of independence and love of challenge. With a presence in more than 70 countries - and growing - we look for talented people to grow our business, advance our science and contribute to our unique culture.
Purpose and Scope of Position:
The Senior Analyst, QC Microbiology works both independently and with the team to perform routine and non-routine microbiological testing in support of sterile product manufacturing. This includes carrying out responsibilities independently in accordance with the organization's policies, procedures, and state, federal and local laws and ensure compliance with current Good Manufacturing Practices (cGMP), USP, EU, BP, JP and other regulatory requirements at all times.
Duties and Responsibilities:
• Ensures compliance with current Good Manufacturing Practice (cGMP), USP, EU, BP, JP and other regulatory requirements at all times.
• Performs routine Microbiological Testing such as Bioburden, Bacterial Endotoxin and Sterility Testing on Water, Raw Materials, In-Process, Finished Products and Components.
• Demonstrates aseptic technique when performing a Microbiological Test.
• Prepares schedules, sample labels and controlled document forms for sampling water and steam systems in accordance with SOP requirements.
• Performs Quality Control Testing of BET reagents, Microbiological Testing Media, and Biological Indicators.
• Performs microbial isolation techniques, gram stain and supports microbial identification process.
• Supports testing (Biological Indicator and Endotoxin Indicators) for the Validation Department Depyrogenation and Sterilization Qualifications.
• Executes basic protocol requirements.
• Written and review Technical and business documents.
• Performs QC Microbiology related Deviation Investigations and Corrective Actions.
• Serve as author of department operating procedures.
• Prepares written monthly/yearly QC Microbiology trend reports.
• Prepares protocol, summary, document change and investigational reports as needed.
• Reviews data generated by other Analysts and ensures compliance with cGMP, USP, EU and other regulatory requirements at all times. Records and interprets data results.
• Provides review and revision of procedures and controlled forms.
• Provides training and mentoring other analysts.
• Performs general laboratory duties.
• Operates laboratory equipment used to provide sterile and depyrogenated materials.
• Monitors and/or orders laboratory supplies and materials.
• Receives laboratory samples, reagents, chemicals and testing media.
• Supports special project under the guidance of QC Microbiology Management.
• Performs other tasks as designed.
• The incumbent will be required to wear uniform/ PPE to work in a manufacturing, warehouse, or laboratory environment.
• The incumbent will be required to maintain a safety alertness due to work around hazardous equipment and cytotoxic product.
Knowledge, Skills, and Abilities:
• Strong written and verbal communication skills.
• Proficient in MS Word, Outlook, and Excel programs as well as PowerPoint, Project and Visio.
• Intermediate ability to interpret / write complex business and technical documents.
• Requires strong presentation development and delivery skills.
• Ability to deal appropriately with regulatory agencies.
• Advanced knowledge of cGMP, OSHA, DEA, USP, EP, and other regulatory guidance documents.
• Requires flexibility and ability to multi-task, strong organizational and time management skills.
• Advanced critical reasoning and decision making skills for solving routine and complex problems that impact multiple departments.
Education and Experience
• High school diploma or equivalent required
• Bachelor's degree preferred
• 3 years' relevant work experience required, preferably in a manufacturing environment with cGMP requirement
• An equivalent combination of education / experience may substitute
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.
REQ ID: 16002183
PRIMARY LOCATION: United States-Arizona-Phoenix
ORGANIZATION: Abraxis Bioscience
EMPLOYEE STATUS: Individual Contributor
JOB TYPE: Full-time
JOB LEVEL: Day Job
JOB POSTING: 2016-12-14 00:00:00.0
14 days 20 hours ago
applySr. Analyst, QC Microbiology Job Celgene Corporation - Phoenix, AZ, United States
Celgene is a multinational biopharmaceutical company committed to improving the lives of patients worldwide. At Celgene, we seek to deliver truly innovative and life-changing drugs for our patients. Our mission 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. There are numerous 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 lymphocyte leukemia (CLL), non-Hodgkin's lymphoma (NHL), glioblastoma, and ovarian, pancreatic and prostate cancer.
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