Analyst I, QC Chemistry (3rd shift)

Employer
Celgene
Location
Phoenix, Arizona, United States
Posted
Feb 12, 2019
Ref
1900502
Required Education
High School or equivalent
Position Type
Full time
Req #: 1900502
Location: Phoenix, Arizona, United States
Job Category: Quality
Work Location: 620 N. 51st Avenue 85043
Organization: Quality Control
Shift: 3rd Shift_USA
Employee Status: Full-time
Job Type: Regular

ANALYST I, QC CHEMISTRY (3rd Shift)
Phoenix, AZ

Purpose and Scope of Position
The Analyst I, QC Chemistry, is responsible for routine analysis of in-process, finished product, raw material and stability samples to ensure that samples meet required specifications. The Analyst I is also responsible for supporting the laboratory through document maintenance and other support activities to ensure the laboratory has documents, solutions and glassware available to perform testing.

Required Competencies: Knowledge, Skills, and Abilities
  • Intermediate PC skills
  • Intermediate math skills
  • Intermediate written and verbal communication skills
  • Basic proficiency in Microsoft Word, Outlook, and Excel.
  • Basic knowledge of electronic document management systems.
  • Intermediate GMP documentation skills.
  • Strong attention to detail.
  • Basic knowledge of laboratory safety practices
  • Intermediate knowledge of technical skills required for analytical chemistry.
  • Ability to use instrumentation and instrument software, including but not limited to TOC, HPLC/GC, Conductivity meter, and PSA.
  • Ability to perform wet chemistry tests, including but not limited to titrations, ROI and pH.
  • Ability to use PPE effectively.
  • Ability to collaborate with peers on day-to-day tasks and more technical tasks; cooperative and works well with a team.
  • Ability to communicate effectively with peers and department management.
  • Ability to accurately and completely understand and follow SOP, test method, and cGMP requirements; uses good judgment and follows procedures.
  • Ability to interpret/write technical documents.
  • Basic knowledge of cGMP, OSHA, DEA, USP, EP, and JP; ability to deal appropriately with regulatory agencies.
  • Ability to make presentations in department setting.
  • Basic strategic thinking and ability to work independently.
  • Ability to work under moderate supervision; limited independent problem solving and priorities assigned.
  • Demonstrates personal organizational skills.
  • Actively seeks opportunities to learn.
  • Ability to pass an initial full physical with annual monitoring.

Duties and Responsibilities
  • Perform testing of raw material, in-process, finished product and stability samples.
  • Perform various wet chemistry and analytical chemistry methods.
  • Follow methods and procedures, with strict adherence to cGMP documentation requirements.
  • Complete all work assigned in a timely manner.
  • Work and communicate effectively within the team to ensure timelines are met.
  • Report all identified problems to designated senior personnel and assist them with troubleshooting problems.
  • Perform revision of documents to ensure appropriate justification of changes.
  • Draft and review SOPs, worksheets, etc.
  • Work with leads and management to determine changes needed.
  • Encourage understanding of the tasks being described in procedures by using written communication skills.
  • Thoroughly document justification for all changes being made.
  • Support lab operations by completing other tasks associated with testing.
  • Prepare various solutions needed to support method performance; for example, mobile phase, needle wash, etc.
  • Participate in housekeeping performance and audits.
  • Review status of supplies and reagents to ensure items are ordered as needed.
  • Perform peer review of testing data.
  • Review all data in accordance with applicable procedures and cGMP requirements.
  • Apply technical knowledge and abilities to ensure all testing is performed in a compliant manner.
  • Complete all review in accordance with required release timelines.Communicate effectively with peers, and demonstrate teamwork, with regards to results of review and corrections required.
  • Perform other tasks as assigned

Education and Experience
  • High school diploma or equivalent required.
  • 1 year relevant work experience required, preferably in a regulated industry.
  • An equivalent combination of education and experience may substitute.

Working Conditions
  • This position requires regular medical surveillance and may require incumbent to wear a respirator or gown.
  • The incumbent must be able to distinguish colors and possess correctable vision to 20/20, annual eye exam is required.
  • The incumbent must analyze numerical values on a daily basis.
  • The incumbent will be working a laboratory setting up to 6 hours per day.
  • The incumbent will occasionally be working around hazardous materials to include chemical agents up to 6 hours per day.
  • The incumbent often works for extended periods alone, up to 8 hours per shift.

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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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.