Catalent Biologics
Biologics
SeniorAssociateQualityAssuranceOperations,DataReview
“Senior Associate - Quality Assurance Operations, Data Review at Catalent Biologics. Skills: Quality Assurance, Data Review, Regulatory Compliance. Maintain and enhance Quality System. Ensure compliant preparation of quality control”
Industry & Context.
What They're Looking For.
Must Have
Master's degree STEM 0 years experience, Bachelor's Degree STEM 3 years experience, Associates Degree STEM 6 years experience, High School Diploma 7 years experience
What You'll Do.
Maintain and enhance Quality System
Ensure compliant preparation of quality control
Ensure compliant execution of quality control
Review analytical data
Review microbiology data
Review documentation for accuracy
Review documentation for completeness
Review documentation for compliance
Report unusual testing results
Report out-of-specification testing results
Review supporting documentation
Ensure traceability to raw data
Verify reagents within acceptance range
Verify standards within acceptance range
Verify equipment within acceptance range
Ensure analysts follow SOPs
Ensure analysts follow CGMP regulations
Work with analysts for corrections
Provide guidance to analysts
Notify Management of quality issues
Notify Management of regulatory issues
Applying for this Senior Associate - Quality Assurance Operations, Data Review role?
Most applicants get filtered before a human reads their resume. See if yours makes the cut.
How to Apply on Workday
- Workday has a multi-step form — save your progress after every section.
- "Apply With LinkedIn" can fail or lose data; manual entry is more reliable.
- Watch for the "Submit for Review" final step — hitting "Save" alone does not submit.
- Job requisition numbers are useful when following up with HR by email.
ANONYMOUS · UNFILTERED
What do employees actually say about Catalent Biologics?
Real rants from real employees. Read before you apply.