QC Analyst II: Analytical Separations

Bora Pharmaceuticals; Rockville, Northern (MD, KY); Hybrid; USD 74,000 - 87,000; Full time

Benefits offered by this job

Health coverage

Retirement plan

Paid time off

Professional development

EAP & Mental Health

Job summary

Bora Biologics in Rockville, MD is seeking a QC Analyst II to support analytical testing programs under cGMP, including in-process, product release and stability testing.

Responsibilities include HPLC, CE, icIEF, Subvisible analysis, data entry in LIMS, data review, handling OOS, CAPAs, and SOP updates; qualified candidates with relevant experience will thrive in a fast-paced, regulated environment.

Qualifications

• High School Diploma and minimum of four (4) years of experience in performing analytical/chemistry testing.
• Associate’s degree in a scientific area of study with three (3) years of related experience
• Bachelor’s Degree in a scientific discipline and minimum of two (2) years of direct related experience.
• Experience in one or more of the following areas required: HPLC, CE, icIEF, and Subvisible Particle analysis, UV absorbance, pH, conductivity, osmolality, Quality Control, and GMP testing.
• Strong knowledge of good laboratory practices.

Responsibilities

• Performs routine analytical testing including methods such as HPLC, CE, icIEF, and Subvisible Particle analysis for in-process, product release, and stability samples.
• Enters data into Laboratory Information Management System (LIMS).
• Performs peer review of test data to ensure data integrity and adherence to SOPs and GMPs.
• Reports out-of-specification results and assists with investigations to determine root cause and resolution.
• Initiates and monitors analytical-related Quality event records (e.g., Deviations and CAPAs) and conducts investigations to determine root cause and possible resolution.
• Performs routine lab cleaning and equipment maintenance activities and escalates potential equipment issues.

Skills

HPLC

CE

icIEF

Subvisible Particle analysis

UV Absorbance

pH

Conductivity

Osmolality

GMP testing

Good Laboratory Practices

Education

Bachelor’s Degree in a scientific discipline

Associate’s degree in a scientific area

High School Diploma

Tools

LIMS

Job description

Bora Biologics in Rockville, MD is seeking a QC Analyst II to support analytical testing programs under cGMP, including in-process, product release and stability testing.

Responsibilities include HPLC, CE, icIEF, Subvisible analysis, data entry in LIMS, data review, handling OOS, CAPAs, and SOP updates; qualified candidates with relevant experience will thrive in a fast-paced, regulated environment.