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Quality Control Scientist
Ref No.: 18-13313
Location: Andover, Massachusetts
Start Date / End Date: 11/05/2018 to 11/04/2019
Job Description: Quality Control Scientist

The Quality Control Analytical group is seeking a highly motivated candidate to support analytical testing activities for multiple products at the Andover site. The work includes various HPLC, UV spectrophotometry, and ELISA methods. The candidate will also be responsible for supporting technical writing, investigations, and other QC analytical business activities at the site.

The qualified candidate will work in a cGMP Quality Control Analytical lab.
Responsibilities include:
• Prepares and record buffers and reagents, etc., and maintain work area in a neat and orderly manner.
• Perform and review analytical testing of in-process, drug substance, and drug product samples.
• Identify basic technical issues, atypical or out-of-specifications test results, instrument
malfunctions and methodology problems and participates in the investigation to resolve and correct.
• Maintain all related data and records in compliance with cGMPs and quality procedures.
• Support laboratory investigations
• Perform laboratory support functions including method revisions and maintain work area in compliance with cGMP and quality procedures.
• Participates in continuous improvement culture within labs. Utilizes continuous improvement
tools such as DMAIC.

• This candidate would interact with immediate group and across the Quality organization.

12-24 months
Support of the tech transfer department

Years of Experience 5-7.
QC Analytical experience and GMP Lab Experience are a must
-Resumes in the past were lacking: GMP Lab, GMP Knowledge,
-Analytical Lab techniques include include but not limited to: HPLC, ELisa, UV Spectrometry, etc.
-Tasks: Run Routine assays, Analytical Lab work, electronic documentation, investigations.
-Plus would be technical writing skills, documentation, electronic documentation, LIMS, investigation experience
- BA in science related field
-previous roles: Analyst, Lab Analyst, Associate Scientist, Analytical Scientist, etc.
-Self motivator, team player

Additional Skills:
Lab Experience in basic analytical methods: HPLC, UV, pH
Knowledge of Advanced analytical methods: Peptide map and Oligosaccharide, ELISA, iCE, Bioassay, CE
Strong oral and written communication skills
Knowledge and understanding of cGMP and industry standards
Proficiency with computer systems (Microsoft Office applications, LIMS, etc.).
Experience working in cGMP, regulatory environment.

What is the minimum education experience required?:
B.S. in Biology, Chemistry or related scientific discipline with a minimum of 5 years of related laboratory experience