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QC Specialist, Analytical Testing

Req #: 1700512
Location: Warren, NJ US
Job Category: Quality
Work Location: 7 Powder Horn Drive WARREN 07059
Organization: Celgene Corporation
Schedule: 40
Shift:
Employee Status: Full time
Job Type: Regular
Job Level:
Travel:
Other Locations:US- NJ- Warren

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.

Duties and Responsibilities:

  • Perform as lead operator with supervisory authority in the QC analytical testing laboratory to guide and facilitate the testing of products to support GPDO’s clinical and commercial timelines.
  • Assist with compliance efforts associated with the major areas of GMP testing including Document Management, Assay Documentation Review, Nonconformance Reporting, and CAPA.
  • Assist with development, implementation, and deployment of training to new employees.
  • Draft and update Standard Operating Procedures (SOPs), testing methods (MTHDs), and other required documents as needed.
  • Represents the department on cross-functional/interdepartmental teams tasked with complex projects.
  • Perform as a lead operator in the transfer of analytical testing methods from Analytical Development to Quality Control and/or to additional testing sites.
  • Assist with troubleshooting and investigations.
  • Represents the department on cross-functional/interdepartmental teams tasked with complex projects.

Other potential responsibilities:

  • Responsible for ensuring the tracking and trending of all analytical data is performed and reviewed in a timely manner.
  • Participate in the development and qualification of new methods with Analytical Development. 
  • Participate, as a GMP testing representative, on project implementation teams to provide a GMP perspective in order to transfer processes into the GMP testing areas in an ordered manner.

Performs general laboratory duties:

  • Perform routine maintenance of QC instruments and equipment and ensures that laboratory areas are clean and maintained in a compliant manner. 
  • Operates laboratory equipment used to prepare samples and generate data.
  • Monitors and/orders laboratory supplies and materials.
  • Performs other tasks as required.
  • Good laboratory documentation skills.

    Required Competencies: Knowledge, Skills, and Abilities include but are not limited to:

  • Understanding of and ability to apply knowledge of cGMP, OSHA, USP, and EU.
  • Knowledge of analytical method transfer guidances.
  • Knowledge of internal quality systems including Celdox, eQRMs, and ComplianceWire.
  • Requires flexibility and ability to multi-task.
  • Strong written and verbal skills.
  • Strong problem solving abilities.
  • Proficiency in basic MS Office Applications including Word, Excel, Sharepoint.
  • Proficiency in analytical analysis software including FlowJo and MiniTab.

    Education and Experience:

  • B.S. degree (or equivalent) in Biochemistry, Biology, Chemistry, or related discipline with 5+ years in a Quality Control laboratory or flow cytometry experience
  • M.S. degree (or equivalent) in Biochemistry, Biology, Chemistry, or related discipline with 2+ years in a Quality Control laboratory or flow cytometry experience
  • Employees must work in areas were posted Universal Precautions must be observed and practiced.  Associates work daily with potentially harmful and/or hazardous agents including asphyxiating gases (nitrogen), biological agents (human cells, bacteria, and viral vectors), and potentially carcinogenic and/or inflammable chemical reagents and sharps.

    Behavioral Competencies:

  • Able to communicate effectively with GPDO functional areas and external agencies.
  • Fosters teamwork and promotes an environment that motivates others to achieve our goals.
  • Exhibits sound scientific judgment based on reasonable assumptions and available information.
  • Responds to challenges and additional projects in an understanding, positive, and objective manner.
  • Adaptable to dynamic conditions, work practices, and project timelines.

#LI-POST

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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