Quality Control Chemist: Precision Lab & GMP Impact

Kdc One; New Albany (OH); On-site; USD 55,000 - 73,000; Full time

Job summary

Kdc/one New Albany is seeking a Quality Control Chemist to ensure incoming materials, in-process batches, and finished goods meet stringent quality standards. You will operate GC, HPLC, and FTIR, prepare CofAs, and release products in SAP, contributing to continuous improvement and regulatory compliance.

Ideal candidates have 3+ years in manufacturing or quality labs and a strong foundation in FDA GMPs, aseptic sampling, and data analysis.

Qualifications

• High school diploma or GED required; Bachelor's in Chemistry or related science strongly preferred.
• 3+ years in manufacturing or quality lab experience required.
• 2+ years training others in lab procedures preferred.
• Expertise in FDA GMPs, aseptic sampling, OSHA requirements, and SAP.
• Strong problem-solving, organizational, and data analysis skills.
• Ability to follow SOPs and multitask in a fast-paced, compliance-driven setting.
• Comfortable working with chemicals and lab equipment and can distinguish colors and odors during testing.

Responsibilities

• Sample and inspect incoming raw materials from chemical tankers and palletized deliveries.
• Run lab tests on RO water, in-process batches, finished bulk, and packaged goods.
• Operate equipment like GC, HPLC, and FTIR to analyze product composition.
• Prepare reagents, run standardizations, and complete Certificates of Analysis (CofA).
• Release product in SAP once quality thresholds are confirmed.
• Support Out of Spec (OOS) investigations and retesting as needed.
• Recommend batch adjustments to stay within spec and keep quality fresh.
• Maintain equipment calibrations and lab cleanliness.
• Write and update SOPs and lab documentation for continuous improvement.
• Protect sensitive data like customer trials, formulas, and proprietary info are safe with you.
• Collaborate with compounding, production, and QA teams daily.

Job description

Kdc/one New Albany is seeking a Quality Control Chemist to ensure incoming materials, in-process batches, and finished goods meet stringent quality standards. You will operate GC, HPLC, and FTIR, prepare CofAs, and release products in SAP, contributing to continuous improvement and regulatory compliance.

Ideal candidates have 3+ years in manufacturing or quality labs and a strong foundation in FDA GMPs, aseptic sampling, and data analysis.