Senior QC Chemist — Analytics, Validation & CAPA

HITEC; Indianapolis, Northern (IN, KY); Hybrid; USD 68,000 - 88,000; Full time

Benefits offered by this job

Medical, dental and vision coverage

401k savings plan

Health savings account (HSA)

Paid time off (Untracked)

Wages accessibility (myFlexPay)

Flexible spending accounts (FSAs)

Disability coverage

Work-Life resources

Paid parental leave

Healthy lifestyle programs

Job summary

Cardinal Health in Indianapolis, IN is seeking a Quality Control analyst to perform analysis of materials, Drug Substance, In-Process and Drug Product samples and to execute verification, validation and transfer protocols. You will conduct stability testing and author SOPs and related documents.

The position requires a Bachelor's degree (or related experience) and 2+ years in FDA-regulated environments, with proficiency in Word/Excel and strong communication.

Qualifications

• Bachelor’s degree or previous work experience in a similar role or related field chemistry, or biology preferred.
• 2+ years of relevant work experience in FDA regulated industry (Pharmaceutical or Medical Device) preferred.
• General knowledge of GDP documentation practices and requirements.
• Experience authoring SOPs, Change Controls, CAPAs, Deviations and Laboratory Investigations.
• Must work well with others and be successful in a team environment.
• Detail oriented, organized, able to multitask, self-starter and self-motivated.
• Proficiency in Microsoft Word and Microsoft Excel and strong technical writing skills.
• Demonstrated success in collaborating with people and teamwork; strong communications skills.

Responsibilities

• Reports to Supervisor, Quality Control (Chemistry).
• Inspects and analyzes incoming materials, Drug Substance, In-Process and Drug Product samples.
• Executes method verification, validation and/or transfer protocols.
• Performs stability testing per stability protocol cadence.
• Authors SOPs, analytical method worksheets and related documents.
• May train others on SOPs, PROTOCOLs, instruments and quality guidelines.
• May execute analytical equipment qualification protocols or computer system validation test scripts.
• Aligns work priorities with supervisor/management.

Skills

Detail oriented

Communication skills

Teamwork

Education

Bachelor’s degree

Tools

Microsoft Word

Microsoft Excel

Job description

Cardinal Health in Indianapolis, IN is seeking a Quality Control analyst to perform analysis of materials, Drug Substance, In-Process and Drug Product samples and to execute verification, validation and transfer protocols. You will conduct stability testing and author SOPs and related documents.

The position requires a Bachelor's degree (or related experience) and 2+ years in FDA-regulated environments, with proficiency in Word/Excel and strong communication.