Senior QA Chemistry Specialist — GMP & Data Integrity

B. Braun US Pharmaceutical Manufacturing LLC; Irvine (CA); On-site; USD 96,000 - 118,000; Full time

Benefits offered by this job

Healthcare

401(k) plan

Tuition reimbursement

Job summary

B. Braun Medical, Inc. in Irvine, CA is seeking a QAO Chemistry Specialist II to provide QA oversight of QC lab operations and ensure GMP compliance.

You will review analytical data and documentation, with expertise in HPLC/UPLC/GC/FTIR and Wet Chemistry, collaborating with QC, Manufacturing and Corporate Quality teams to drive investigations and CAPAs. The role requires a Bachelor’s degree and 6+ years in pharma/biotech QA/QC chemistry, with proficiency in LabWare LIMS, SAP, TrackWise and

Qualifications

• Bachelor's degree or equivalent combination of education and experience.
• 6+ years of experience in pharma/biotech/medical device or related manufacturing environments.
• QA/QC Chemistry background with experience reviewing analytical data and lab records.
• Knowledge of HPLC, UPLC, GC, FTIR, Wet Chemistry methodologies.
• Experience with LabWare LIMS, SAP, TrackWise, and Empower.
• Strong GMP, FDA, ICH knowledge and data integrity principles.
• Excellent problem-solving, organizational, and communication skills.

Responsibilities

• Provide QA oversight of QC laboratory operations and quality systems to ensure GMP/regulatory compliance.
• Review and approve analytical data, lab documentation, protocols, reports and records supporting product release.
• Review data from HPLC/UPLC/GC/FTIR/Wet Chemistry to ensure accuracy and compliance.
• Utilize Empower, LabWare LIMS, SAP and TrackWise to support data review and investigations.
• Support deviations, investigations, OOS/OOT events, CAPAs, change controls and validation activities.

Skills

QA/QC Chemistry

HPLC

UPLC

GC

FTIR

Wet Chemistry

Empower

LabWare LIMS

SAP

TrackWise

Education

Bachelor's degree

Tools

Empower Chromatography Data System

LabWare LIMS

SAP (ERP)

TrackWise

Job description

B. Braun Medical, Inc. in Irvine, CA is seeking a QAO Chemistry Specialist II to provide QA oversight of QC lab operations and ensure GMP compliance.

You will review analytical data and documentation, with expertise in HPLC/UPLC/GC/FTIR and Wet Chemistry, collaborating with QC, Manufacturing and Corporate Quality teams to drive investigations and CAPAs. The role requires a Bachelor’s degree and 6+ years in pharma/biotech QA/QC chemistry, with proficiency in LabWare LIMS, SAP, TrackWise and