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 experience
- Proficiency 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 options
- Life and disability insurance
- 401(k) with company match
- Paid vacation and holiday
- Yearly goal-based bonus & eligibility for merit-based increases
- Compensation: $33.00-$41.00 per hour based on education and experience
Eurofins USA PSS Insourcing Solutions is a Disabled and Veteran Equal Employment Opportunity employer.
