Manufacturing QA Chemist Job at Antech Diagnostics (Brownsburg)

Job Description

The Manufacturing QC Chemist is responsible for supporting Quality Control and Quality Assurance functions to ensure all products and manufacturing processes meet established quality standards and regulatory requirements. This role plays a key part in maintaining product integrity, compliance, and continuous improvement within the manufacturing environment.

Job Responsibility

Perform visual inspections and laboratory analyses to verify product quality and compliance
Perform laboratory assays (e.g., PCR, ELISA, radioactive/fluorescent assay) and support validation of new & existing products and processes
Document, report, and investigate non-conformance issues
perform root cause analysis and recommend corrective actions
Monitor QC parameters using statistical tools (e.g., Levy-Jennings charts) and maintain accurate records in QA databases
Calibrate, maintain, and troubleshoot laboratory equipment and instrumentation
Handle hazardous chemicals and small quantities of radioactive materials in accordance with safety and regulatory guidelines (e.g., NRC regulations)
Assist with sample collection, validation studies, and initial data review for new & existing products
Support method and assay validation, including analytical testing and documentation
Participate in internal audits and continuous improvement initiatives within manufacturing and Biobank facilities
Ensure compliance with SOPs, Batch Production Records (BPR), and company/industry quality standards
Implement and track corrective and preventive actions (CAPA)
Maintain positive working relationships and effective communication across departments
Adhere to all safety regulations and company policies
Prepare detailed inspection and audit reports for management review
Perform other related duties as assigned

Requirements

Associates degree required/ bachelor’s degree in science related discipline preferred
Experience with general laboratory and IVD manufacturing equipment
Knowledge of GMP, GLP, & GDP standards
Experience handling hazardous chemicals
Experience in general reagent compounding or buffer preparation
Proficiency in laboratory techniques, including precision filling and pipetting
Familiarity with molecular assays (PCR, ELISA, radioactive, fluorescent)
Strong statistical analysis skills
High attention to detail and commitment to work quality
Effective problem-solving abilities
Strong verbal and written communication skills
ability to collaborate across teams
Basic computer proficiency (Excel, Word, familiar with MRP System software)

What we offer

Paid Time Off & Holidays
Medical, Dental, Vision (Multiple Plans Available)
Basic Life (Company Paid) & Supplemental Life
Short and Long Term Disability (Company Paid)
Flexible Spending Accounts/Health Savings Accounts
Paid Parental Leave
401(k) with company match
Tuition/Continuing Education Reimbursement
Life Assistance Program
Pet Care Discounts

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Manufacturing QA Chemist

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