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.
Environmental Control Analyst, QC
Purpose and Scope of Position
QC Environmental Control Analyst works both independently and with the team to collect,
analyze and trend environmental monitoring results for the controlled non-aseptic area, aseptic
area, and aseptic personnel. This position requires personnel to create procedures and methods pertaining to environmental monitoring.
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.
· Intermediate written and verbal communication skill.
· Basic Ability to Interpret and write general business documents.
· Basic ability to Interpret and write technical documents.
· Intermediate Problem-solving skills.
· Ability to follow direction well, work cooperatively as an individual contributor and as a team
· 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.
· Trends site specific data.
· Assist in the creation, maintenance, and delivery of controlled and aseptic area training
Performs other tasks as assigned.
4. Education and Experience
· Bachelor’s degree preferred, preferably in science or related field.
· 0-2 years’ 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 involves working conditions with constricted personnel movements for up to 6
hours a day.
· This position works within controlled environments with strict gown and gloves requirements.
6. Definitions and Abbreviations
· United States Pharmacopeia (USP)
· European Union (EU)
· 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.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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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.