Reporting to the Supervisor of Quality Control Chemistry, this individual will be primarily responsible for executing release and stability testing as well as participating in technical transfers from analytical development (method acquisition and qualification/validation). This role will be crucial in the establishment of QC operations at the new Norwood, MA site.
location: Norwood, Massachusetts
job type: Contract
salary: $31.39 - 36.93 per hour
work hours: 9 to 5
- Performs routine analytical chemistry testing including HPLC, UPLC, CE, etc.
- Supports assay acquisitions, qualifications and validations as well as special projects as assigned
- Participates in authoring quality systems records such as deviations, change controls, CAPAs
- Troubleshoots assay methods and equipment.
- Supports investigations for OOS and other non-conforming results; may assist with investigations related to CMO/contract laboratory activities
- Performs data trending and supports analysis
- Performs general laboratory support activities including reagent preparation, sample management, equipment maintenance, lab housekeeping etc.
- Write/revise SOPs, protocols and reports
- BS/BA preferred with a minimum 2-5 years in cGMP environment
- In-depth knowledge of relevant FDA, EU, ICH guidelines and regulations.
- Strong knowledge of digital quality systems (LIMS, QMS, ERP) preferred.
- Experience with method acquisition, qualification and validation.
- Excellent quality control judgment and ability to assess, communicate and resolve complex issues efficiently and effectively.
- Outstanding communication skills (verbal and written).
- Ability to manage multiple projects in a fast-paced environment.
- Ability to effectively collaborate effectively in a dynamic, cross-functional matrix environment.
skills: FDA, CAPA, 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.