Senior Specialist, Quality Control Chemist II

Cardinal Health•Indianapolis, IN

20d•Onsite

About The Position

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

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.
Has general knowledge of GDP documentation practices and requirements
Has experience in authoring a variety of forms of documentation such as SOPs, Change Controls, CAPAs, Deviations and Laboratory Investigations.
Must work well with others and understand how to be successful in a team environment.
Must be detail oriented, organized, able to multitask, a self-starter, and self-motivated.
Must be proficient in Microsoft Word and Microsoft Excel and possess strong technical writing skills.
Demonstrated success in collaborating with people and working on a team.
Strong communications 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.
Execute method verification, validation and/or transfer protocols.
Perform stability testing in alignment with stability protocol(s) at the prescribed cadence.
Authors standard operating procedures, analytical method worksheets, forms and other documents as necessary and applicable.
Demonstrates detail-oriented attention in all facets of responsibilities.
Performs visual assessment and analytical evaluation or test of products or processes.
Demonstrates knowledge of testing methods, product usage, and applicable regulations and standards.
Adheres to established policies and procedures.
Establishes test methodology.
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 immediate supervisor/management.
Gain awareness of other departments at site. Seek to understand the functions of those departments and the points of interaction between Quality Control and your role.
Exhibits Cardinal Health's high ethical standards and code of conduct.
Performs special projects or tasks as necessary based on skill set and/or development goals and business needs.
Performs other job duties as assigned.
Required to have visual acuity and color perception Near-vision performance should be the equivalent of 20/20 with no impairment of color vision or correctable to 20/20 vision with the use of corrective lenses.