Data Review Specialist

Data Review Specialist

WHO?

INCOG Biopharma Services is seeking a highly motivated Data Review Specialist to work alongside the QA Technical Manager to review and approve QC documentation. INCOG is offering the opportunity to contribute towards a better path to market for life-saving drugs. Having recently been voted as one of the Best Places To Work in Indiana for the second year in a row, INCOG is the perfect place to continue building your career.

WHAT?

• Perform laboratory Data Review processes for incoming materials, in-process, finished product, and stability testing from QC Chemistry and QC Microbiology, partnering with QC in the data analysis and Data Review processes.
• Evaluate the scope and impact of deviations, the requirements for product segregation, and the implementation of CAPAs. Ensure data integrity for policies, procedures, and testing records with the use of various paper and automated systems (Veeva, SCADA, BMS, CMMS, etc)
• Analyze and track investigations and identify sources of variability and error in QC processes. Use data trends to apply a systematic approach to resolve technical issues, prevent errors, identify improvement opportunities, and implement continuous improvement plans.

YOU!

The successful candidate will have a Bachelor’s degree in a Science field (Chemistry, Biology, Biochemistry), as well as a minimum of 2 years biopharma experience. They will also have at least 1 year of experience with isolator-based aseptic manufacturing, and an understanding of aseptic QC manufacturing testing processes.

Don’t meet all the requirements? Don’t sweat! We’re always looking for an excuse to discuss your next opportunity. You might just surprise yourself…

Lead Candidate wholeheartedly supports Equality and Diversity in employment and opposes all forms of unlawful or unfair discrimination on the grounds of age, disability, sex, gender reassignment, sexual orientation, pregnancy and maternity, race, religion or belief and marriage and civil partnerships

Job Type: Full-time

Salary: $53,253.00 - $75,231.00 per year

Benefits:

• 401(k)
• Dental insurance
• Flexible schedule
• Health insurance
• Paid time off
• Vision insurance

Schedule:

• 8 hour shift
• Monday to Friday

Ability to Relocate:

• Fishers, IN 46037: Relocate before starting work (Required)

Work Location: In person