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Associate Analyst, QC Microbiology (Enviro)

Req #: 1700905
Location: Phoenix, AZ US
Job Category: Quality
Work Location: 620 N. 51st Avenue PHOENIX 85043
Organization: Abraxis Bioscience
Schedule: 40
Shift:
Employee Status: Full time
Job Type: Regular
Job Level:
Travel:
Other Locations:US- AZ- Phoenix

Description

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

QC Environmental Control Associate Analyst works both independently and with the team to collects, analyzes and trends environmental monitoring results for the Controlled non-aseptic area, aseptic area, compressed gases, and aseptic personnel.

2. Required Competencies: Knowledge, Skills, and Abilities

  • Requires the ability to deal appropriately with regulatory agencies
  • Ability to multi-task and work flexible work schedule.
  • Basic written and verbal communication skills.
  • Basic ability to interpret general business documents.
  • Basic Problem solving skills.
  • Ability to work cooperatively as an individual contributor and as a team member.
  • Ability to gown and maintain a sterile work environment.
  • Ability to work independently for extended periods of time.
  • Basic proficiency in Microsoft Word, Outlook, and Excel.
  • Basic knowledge of cGMP, OSHA, DEA, USP, and EP.
  • Ability to pass an initial full physical with annual monitoring.

3. Duties and Responsibilities

Collect environmental monitoring samples:

  • Collect viable and non-viable samples within controlled environments.
  • Collect viable and non-viable samples for compressed gases.
  • Collect personnel glove and gown samples.

Participates in aseptic process qualifications:

  • Aseptic gowning
  • Media fills

Documents, Tracks, and Trends test results:

  • Record daily data results.
  • Prepares spreadsheets of data.

Training:

  • Assist in the creation of controlled and aseptic area training modules.

Performs other tasks as assigned.

Education and Experience

  • High school diploma or equivalent required.
  • 1 year of relevant work experience required, preferably in a regulated manufacturing environment with cGMP requirements.
  • An equivalent combination of education, experience and training may substitute.

5. Working Conditions

  • This position involves being fully gowned for extended periods of time within a restrictive movement environment. This may include standing, bending, reaching, kneeling, balancing, pushing, pulling, lifting (NMT 25lb), or carrying (NMT 25lb).
  • This may also include concentrating, remembering names, effective verbal and/or written communication, analytical thinking, decision making, and adapting to change.
  • This position works within controlled environments with strict gown and gloves requirements.
  • This position involves working conditions with constricted personnel movements for up to 6 hours a day.

6. Definitions and Abbreviations

  • United States Pharmacopeia (USP)
  • European Union (EU)
  • Japanese Pharmacopeia (JP)
  • British Pharmacopeia (BP)
  • Occupational Safety and Health Administration (OSHA)
  • US Drug Enforcement Administration (DEA)
  • Personnel Protective Equipment (PPE)

This job description is intended to describe the general nature and level of work being performed by the person assigned to this position. The primary duties and responsibilities are intended to describe those functions that are essential to the performance of this job.

This job description does not state or imply that the above are the only duties and responsibilities assigned to this position. There are other duties and responsibilities that are considered incidental or secondary to the overall purpose of this job. Employees holding this position will be required to perform any other job-related duties as requested by management.

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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.
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About Celgene

Celgene is a global biopharmaceutical company committed to improving the lives of patients worldwide. At Celgene, we seek to deliver truly innovative and life-changing treatments for our patients.

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