QC Data Review and Compliance Specialist

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.

Qualifications :

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.

Additional Information :

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.

Remote Work :

No

Employment Type :

Full-time