QC Data Reviewer

Insight Global is looking for a Quality Control Data Reviewer to sit on-site in Boston, MA at a large global pharmaceutical company. This person will be on-site, 5 days a week in the beautiful Seaport district. They will be supporting the Equipment Calibration and Maintenance team through reviewing and overseeing instrument qualification and requalification packages executed by vendors.

An ideal candidate for this role will have either analytical or micro based lab or lab adjacent experience. Great verbal and written communication skills are critical for this position, as they will perform cGMP analytical and microbiological data review for various techniques, such as HPLC, GC, Environmental monitoring, and dissolution to ensure adherence to established methodology, procedures and SOPs. This is a great opportunity to join a growing team and get your foot in the door at an innovative pharmaceutical company.



· Perform cGMP analytical and microbiological data review for various techniques such as HPLC, GC, KF, TOC, Bioburden, endotoxin, TOC, Environmental monitoring, IR and dissolution to ensure adherence to established methodology, procedures and SOPs

· Assisting with maintenance and calibration activities

· Review laboratory instrument qualification and requalification packages executed by vendors

· Review laboratory equipment logbooks

· Provide support and oversight of laboratory equipment PM/calibration program to ensure on-time completion

Ensure all laboratory records are accurate and adhere to cGMP/GDP expectation

· 2 years GMP/GDP lab or lab adjacent experience (can be analytical or micro)

o Knowledge of QMS (Veeva), CMMS (Maximo, Nuvolo), and LIMS

· Bachelor's Degree in Lab Sciences, such as Chemistry, Biochemistry, Material Science, Immunology

· Strong technical knowledge including an understanding of laboratory procedures, methodology and standards

· Strong verbal and written communication skills

Strong attention to detail

Benefit packages for this role will start on the 31st day of employment and include medical, dental, and vision insurance, as well as HSA, FSA, and DCFSA account options, and 401k retirement account access with employer matching. Employees in this role are also entitled to paid sick leave and/or other paid time off as provided by applicable law.