Senior Quality Control Chemist II

1d1 day ago

Cardinal Health

Indianapolis, US · Full-time · $67,500 – $95,000

About this role

Quality Control develops and implements quality policies, procedures, and processes to ensure products and services comply with regulatory standards and specifications. This role is responsible for the analysis or inspection of materials, components, products or processes for compliance with specifications and standards.

The Senior Specialist ensures timely and thorough inspections and analysis of incoming materials, Drug Substance, In-Process and Drug Product samples. They perform investigations, deviations, change controls and CAPAs, and execute method verification, validation and/or transfer protocols. Stability testing is performed in alignment with stability protocols at the prescribed cadence.

This role reports to the Supervisor, Quality Control (Chemistry) and works onsite in Indianapolis. The candidate must adhere to established policies, demonstrate knowledge of testing methods, and exhibit Cardinal Health's high ethical standards. They are required to have visual acuity and color perception, with near-vision performance equivalent to 20/20.

The specialist may train others on SOPs, protocols, instruments and quality guidelines. They may also execute analytical equipment qualification protocols or computer system validation test scripts, gaining awareness of other departments and their interactions with Quality Control. This provides opportunities to develop cross-functional knowledge and contribute to continuous improvement.

Requirements

Bachelor’s degree or previous work experience in a similar role or related field (chemistry or biology preferred).
2+ years of relevant work experience working with 21 CFR 210, 211 in the FDA regulated industry (pharmaceutical or medical device) preferred.
General knowledge of GDP documentation practices and requirements.
Experience in authoring documentation such as SOPs, Change Controls, CAPAs, Deviations and Laboratory Investigations.
Detail-oriented, organized, able to multitask, self-starter, and self-motivated.
Proficient in Microsoft Word and Microsoft Excel with strong technical writing skills.
Demonstrated success in collaborating with people and working on a team.
Strong communication skills.

Responsibilities

Ensures timely and thorough inspections and analysis of incoming materials, Drug Substance, In-Process and Drug Product samples.
Performs investigations, deviations, change controls and CAPAs.
Executes method verification, validation and/or transfer protocols.
Authors standard operating procedures, analytical method worksheets, forms and other documents.
Performs stability testing in alignment with stability protocol(s) at the prescribed cadence.
May train others on SOPs, protocols, instruments and quality guidelines.
May execute analytical equipment qualification protocols or computer system validation test scripts.
Demonstrates detail-oriented attention and performs visual assessment and analytical evaluation of products or processes.