Overview
Quality Control Analyst Jobs in Indianapolis, Indiana, USA at Harba Solutions Inc.
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This range is provided by Harba Solutions Inc. Your actual pay will be based on your skills and experience — talk with your recruiter to learn more.
Base pay range
$70.00/yr – $85.00/yr
Responsibilities:
SOPs, safety (radiation, industrial), on-the-job training for QC methods.
Assist with IQ/OQ/PQ of new equipment and instrument software.
Supervise and learn from field engineers when they are on-site.
Draft/Review documents such as SOPs, Forms, FMECA, tech transfer protocol, and analytical method validation protocols.
Tech transfer, implementation, improvements, and full validation of QC methods.
QC testing for batch release within hours of production.
Continue all tasks from the Setup Phase into the Production Phase.
Follow EHS regulations, including NRC (ALARA), OSHA, EPA, chemical, waste disposal, etc.
Adhere to SOPs, cGMP requirements, company policies, and regulatory requirements.
Maintain readiness for inspection at all times.
Verify calibration/qualification status of instruments.
Gather raw materials and confirm they are not expired.
Conduct system suitability testing of instruments.
Perform testing for Chemistry QC, Microbial testing, and ensure proper documentation.
Help maintain backup supplies for QC, including spare parts, consumables, PPE, and other supplies.
Assist with the recruitment/training of new employees.
Promote a culture of quality and continuous improvement.
Assist with Quality Events (deviations, OOT/OOS, CAPAs, change controls, recalls, complaints, FMEAs, audits, inspections, investigations).
Assist with repeating equipment qualification and/or method validation as needed.
On-site 100%.
Qualifications:
3 years of experience in QC, including 1 year of QC under 21 CFR Parts 11, 210, 211.
Strong character with integrity, teamwork, customer service, and openness.
Demonstrate safety, quality, problem-solving, continuous improvement, and determination.
Teachable:
Ability to listen, ask questions, accept feedback, admit mistakes, and learn quickly.
Own QC methods and work with urgency in a fast-paced environment.
Ability to execute multiple tasks simultaneously.
Experience in safety and waste management (laboratory, chemical, hazmat).
Proficiency with analytical instruments, HPLC, USP methods, ICH guidelines, GMP practices.
Experience in validation of analytical methods.
Ability to present/defend QC programs during inspections.
Expertise in following detailed SOPs and meticulous execution/documentation (GDP).
Familiarity with QMS in regulated environments.
Excellent technical skills and troubleshooting abilities.
Ability to meet same-day deadlines and overcome obstacles to resolve problems quickly, while meeting cGMP standards.
Seniority level
Associate
Employment type
Full-time
Job function
Analyst, Manufacturing, and Quality Assurance
Industries
Pharmaceutical Manufacturing
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Title: Quality Control Analyst
Company: Harba Solutions Inc.
Location: Indianapolis, Indiana, USA
Category: Quality Assurance – QA/QC (Quality Control / Manager, Quality Technician/ Inspector, QA Specialist / Manager)
