- 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
location: Andover, Massachusetts
job type: Contract
salary: $27.00 - 31.76 per hour
work hours: 9 to 5
- The qualified candidate will work in a cGMP Quality Control Analytical lab.
- 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
- Support of the tech transfer department
- B.S. in Biology, Chemistry or related scientific discipline with a minimum of 5 years of related laboratory experience
- Lab Experience in basic analytical methods: HPLC, UV, pH
- Knowledge of Advanced analytical methods: Peptide map and Oligosaccharide, ELISA, iCE, Bioassay, CE
- QC Analytical experience and GMP Lab Experience are a must
- 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.
- Tasks: Run Routine assays, Analytical Lab work, electronic documentation, investigations.
- Plus would be technical writing skills, documentation, electronic documentation, LIMS, investigation experience
- Self motivator, team player
- Years of Experience 5-7
skills: HPLC, Analytical Chemistry, GMP (Good Manufacturing Practice)
Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.