QC Data Review and Compliance Specialist at Eurofins

Boston, Massachusetts, United States -

Full Time

Start Date

Immediate

Expiry Date

04 May, 26

Salary

41.0

Posted On

03 Feb, 26

Experience

2 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Data Entry, Data Review, Compliance, Documentation, Analytical Method Performance, Organizational Skills, Attention to Detail, Time Management, Multitasking, Effective Communication

Industry

Medical and Diagnostic Laboratories

Description

Company Description The work we do at Eurofins Professional Scientific Services matters, and so do our employees. At Eurofins PSS, we put a focus on your professional growth. We provide our employees the ability to break into the biopharmaceutical industry and grow from the bottom up. We have the supportive teams and tools available to invest in you while also affording you work-life balance and a competitive benefits package. Eurofins Scientific is an international life sciences company, providing a unique range of analytical testing services to clients across multiple industries, to make life and our environment safer, healthier and more sustainable. From the food you eat, to the water you drink, to the medicines you rely on, Eurofins works with the biggest companies in the world to ensure the products they supply are safe, their ingredients are authentic and labelling is accurate. Eurofins believes it is a global leader in food, environmental, pharmaceutical and cosmetics products testing and in agroscience CRO services. It is also one of the global independent market leaders in certain testing and laboratory services for genomics, discovery pharmacology, forensics, CDMO, advanced material sciences and in the support of clinical studies. If you’re looking for a rewarding career, a place to call home, apply with us today! Job Description 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. Compensation: USD33 - USD41 - hourly

Responsibilities

The role involves supporting cGMP Quality Control operations with a focus on data entry, review, compliance, and documentation related to testing. Responsibilities also include supporting stability evaluations, monitoring analytical method performance, and assisting in authoring protocols and reports.