Eurofins PSS Insourcing Solutions · 15 hours ago
QC Data Review and Compliance Specialist
Boston, MA
Full-time
Onsite
Mid Level
$33/hr - $41/hr
3+ years expEurofins PSS Insourcing Solutions is a leader in analytical testing services, focusing on the biopharmaceutical industry. The QC Data Review and Compliance Specialist will support cGMP Quality Control operations, emphasizing data entry, review, compliance, and documentation related to testing of DNA, mRNA, gRNA, and LNP.
Biotechnology
No H1B
Responsibilities
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
Qualification
Required
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
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
Benefits
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
Company
Eurofins PSS Insourcing Solutions
Welcome to Eurofins Professional Scientific Services® (PSS), where we redefine industry norms in insourcing solutions, creating unparalleled value for both our dedicated employees and esteemed clients.
1001-5000 employees
Funding
Current Stage
Late StageCompany data provided by crunchbase