Specialist, Quality Control - Physical Chemistry
Novartis
14 hours ago
On-site
Durham, NC
Operations
Key Responsibilities:
- Execute routine and non-routine cGMP release and characterization analysis (e.g., chromatography HPLC/UPLC, AUC, SEC, compendial assays like pH/conductivity/osmolality, electrophoresis such as CE/Western Blot) and assist with data review.
- Execute method verifications/transfers for various projects.
- Assist with vendor enrollment and ordering reagents/consumables for new assays.
- Initiate testing and transfer paperwork (LIMS, SOPs, assay forms).
- Assist with evaluation of internal controls, communications, risk assessments, and documentation maintenance for safety, quality, and regulatory compliance.
- Review data for specification compliance; report abnormalities; perform trend analysis and draw conclusions.
- Support department risk assessments and participate in audit walkthroughs.
- Prepare investigations/summaries/reports; resolve non-conforming results via Deviation, OOS/OOT/OOE and Investigation.
- Author/revise QC SOPs, protocols/summary reports, and analytical master plans.
- Oversee analytical/instrument problem-solving special projects; may develop methods.
- Support training for departmental personnel.
- Other related duties as assigned.
Essential Requirements:
- Bachelor’s degree in scientific disciplines (Biochemistry/Biology/Microbiology or related) with 5 years’ GMP environment experience (or 4 years at GTx).
- Excellent interpersonal, verbal, written communication, and technical writing; investigation experience a plus.
- Proven team collaboration; cross-functional collaboration.
- Ability to work problems of moderate scope requiring review of multiple factors.
- Judgment within defined procedures; critical thinking, troubleshooting, problem-solving.
- Self-motivated, detail-oriented; willing to accept temporary responsibilities.
Benefits/Compensation (as stated):
- Salary expected to range: $41.06–$76.25 per hour.
- Performance-based cash incentive; possible annual equity awards.
- Comprehensive benefits for US-based eligible employees and time off package.
Application/Location:
- On-site role in Durham, NC; no relocation support—apply if accessible.
- Execute routine and non-routine cGMP release and characterization analysis (e.g., chromatography HPLC/UPLC, AUC, SEC, compendial assays like pH/conductivity/osmolality, electrophoresis such as CE/Western Blot) and assist with data review.
- Execute method verifications/transfers for various projects.
- Assist with vendor enrollment and ordering reagents/consumables for new assays.
- Initiate testing and transfer paperwork (LIMS, SOPs, assay forms).
- Assist with evaluation of internal controls, communications, risk assessments, and documentation maintenance for safety, quality, and regulatory compliance.
- Review data for specification compliance; report abnormalities; perform trend analysis and draw conclusions.
- Support department risk assessments and participate in audit walkthroughs.
- Prepare investigations/summaries/reports; resolve non-conforming results via Deviation, OOS/OOT/OOE and Investigation.
- Author/revise QC SOPs, protocols/summary reports, and analytical master plans.
- Oversee analytical/instrument problem-solving special projects; may develop methods.
- Support training for departmental personnel.
- Other related duties as assigned.
Essential Requirements:
- Bachelor’s degree in scientific disciplines (Biochemistry/Biology/Microbiology or related) with 5 years’ GMP environment experience (or 4 years at GTx).
- Excellent interpersonal, verbal, written communication, and technical writing; investigation experience a plus.
- Proven team collaboration; cross-functional collaboration.
- Ability to work problems of moderate scope requiring review of multiple factors.
- Judgment within defined procedures; critical thinking, troubleshooting, problem-solving.
- Self-motivated, detail-oriented; willing to accept temporary responsibilities.
Benefits/Compensation (as stated):
- Salary expected to range: $41.06–$76.25 per hour.
- Performance-based cash incentive; possible annual equity awards.
- Comprehensive benefits for US-based eligible employees and time off package.
Application/Location:
- On-site role in Durham, NC; no relocation support—apply if accessible.