Harba Solutions Inc.
Quality Control Chemist
The Quality Control Chemist is responsible for performing analytical testing of raw materials, in-process samples, and finished products to ensure compliance with GMP, regulatory requirements, and internal quality standards.
Key Responsibilities
Perform routine and non‑routine chemical analyses using validated analytical methods
Execute testing using techniques such as
HPLC, LC‑MS, GC, UV‑Vis, FTIR, pH, conductivity, and titration
Prepare standards, reagents, and mobile phases
Review, analyze, and document test results in compliance with
GMP and Good Documentation Practices (GDP)
Support batch release testing and stability studies
Investigate
out‑of‑specification (OOS)
and
out‑of‑trend (OOT)
results
Assist with deviations, CAPAs, method transfers, and validations
Maintain laboratory equipment, calibration, and logbooks
Support internal and external audits (FDA, ISO)
Required Skills & Qualifications
Bachelor’s degree in
Chemistry, Biochemistry, or related field
Hands‑on experience with
LC‑MS and HPLC
preferred
Strong knowledge of
GMP/cGMP
and regulatory requirements
Attention to detail and strong data integrity practices
Ability to work independently in a regulated lab environment
Additional Information
Seniority level: Associate
Employment type: Full‑time
Job function: Research, Quality Assurance, and Manufacturing
Industries: Biotechnology Research, Pharmaceutical Manufacturing, and Medical Equipment Manufacturing
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Key Responsibilities
Perform routine and non‑routine chemical analyses using validated analytical methods
Execute testing using techniques such as
HPLC, LC‑MS, GC, UV‑Vis, FTIR, pH, conductivity, and titration
Prepare standards, reagents, and mobile phases
Review, analyze, and document test results in compliance with
GMP and Good Documentation Practices (GDP)
Support batch release testing and stability studies
Investigate
out‑of‑specification (OOS)
and
out‑of‑trend (OOT)
results
Assist with deviations, CAPAs, method transfers, and validations
Maintain laboratory equipment, calibration, and logbooks
Support internal and external audits (FDA, ISO)
Required Skills & Qualifications
Bachelor’s degree in
Chemistry, Biochemistry, or related field
Hands‑on experience with
LC‑MS and HPLC
preferred
Strong knowledge of
GMP/cGMP
and regulatory requirements
Attention to detail and strong data integrity practices
Ability to work independently in a regulated lab environment
Additional Information
Seniority level: Associate
Employment type: Full‑time
Job function: Research, Quality Assurance, and Manufacturing
Industries: Biotechnology Research, Pharmaceutical Manufacturing, and Medical Equipment Manufacturing
#J-18808-Ljbffr