Senior Specialist, Quality Control Chemist II (2nd shift)

Cardinal Health•Indianapolis, IN

14d•$68,500 - $88,020•Onsite

About The Position

This role reports to the Supervisor, Quality Control (Chemistry) and is responsible for ensuring timely and thorough inspections and analysis of incoming materials, Drug Substance, In-Process and Drug Product samples. The position involves performing investigations, deviations, change controls, and CAPAs. It also includes executing method verification, validation, and/or transfer protocols, as well as performing stability testing. The Senior Specialist will author standard operating procedures, analytical method worksheets, and other necessary documents. A key aspect of this role is demonstrating detail-oriented attention in all responsibilities, performing visual assessment and analytical evaluation of products or processes, and demonstrating knowledge of testing methods, product usage, and applicable regulations and standards. Adherence to established policies and procedures, establishing test methodology, and potentially training others on SOPs, protocols, instruments, and quality guidelines are also expected. The role may involve executing analytical equipment qualification protocols or computer system validation test scripts. Alignment of work priorities with immediate supervisor/management and gaining awareness of other departments at the site are important. The position requires exhibiting Cardinal Health's high ethical standards and code of conduct, and performing special projects as necessary.

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.
The ability to act calmly and patiently when working under pressure and/conditions of stress.
Maintains integrity, composure, communicates with honesty, transparency, clarity and promotes alternative perspectives.

Nice To Haves

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.

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.
Perform analysis of Incoming Materials, Drug Substance, In-Process and Drug Product samples.
Execute method verification, validation and/or transfer protocols.
Perform stability testing in alignment with stability protocol(s) at the prescribed cadence.
May execute analytical equipment qualification protocols or computer system validation test scripts.
Approaches work situations with a positive and energizing style.
Exhibit professional conduct and respect for others.