About this role
This non-laboratory role will support cGMP Quality Control operations with a focus on data entry, data review, compliance, and documentation related to testing of DNA, mRNA, gRNA, and LNP.
Support stability evaluations and shelf-life extensions of drug substance and drug product through population of a stability database with relevant data and generation of trending charts in addition to protocol and report authoring.Support monitoring of analytical method performance through generation of trending templates, population of database with relevant method performance indicators, and generation of trending reports.Support the shipment of quality control samples and critical reagents from/to CDMOs and contract laboratories.Perform verification of data generated internally and externally in support of method qualification/validation, lot release, and stability activities.Assist in authoring and review of internal and external protocols and reports related to analytical method qualifications/validations and product stability.Support of cGMP operations, including generation of documentation in support of change controls, CAPAs, deviations, OOS, and other investigations or assay troubleshooting. Minimum Required Qualifications:
B.S. in Chemistry, Biology, or related field with 3-4 years of relevant experienceProficiency in Microsoft Word and Excel. Strong organizational skills, attention to detail, and accuracy in documenting results.Strong time management and multitasking abilities.Ability to work independently and collaborate in a cross-functional environment.Effective communication and documentation skills.Preferred Qualifications:
Experience in a clinical, QC, QA, GLP- or GMP-regulated environment is preferred.Familiarity with software systems such as SLIM, Veeva, JMP, and LIMS.Familiarity with cell-based assays, ELISA, PCR, and data analysis.Authorization to work in the United States indefinitely without restriction or sponsorship. Position is Full Time, Monday-Friday, 8am-5 pm. Candidates currently living within a commutable distance of Boston, MA are encouraged to apply
Excellent full-time benefits include:
Comprehensive medical coverage, dental, and vision optionsLife and disability insurance401(k) with company matchPaid vacation and holidayYearly goal-based bonus & eligibility for merit-based increasesCompensation: $33.00-$41.00 per hour based on education and experienceEurofins USA PSS Insourcing Solutions is a Disabled and Veteran Equal Employment Opportunity employer.