Reports to Supervisor, Quality Control (Chemistry)
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.
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.
Location
Onsite in Indianapolis, IN
Performance Expectations
Demonstrates a commitment to the organization's mission, vision and values supporting organizational decisions and behaviors. Contributes to the development and implementation of systems and processes ensuring strategic goal attainment.
Works as part of a team with others and shows respect and values diversity toward others.
Takes actions to continually improve quality and safety in daily work. Actively participates in improving work processes to meet and exceed expectations. Identifies opportunities for improvement based on process observations, outcome measures, and feedback.
Reports errors in a timely and appropriate manner. Takes initiative and is accountable for areas of responsibility meeting regulatory requirements including but not limited to maintaining required trainings as appropriate to position requirements.
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.
Physical/ Mental Requirements
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job.
Work Environment
The primary work environment consists of a professional office environment within a radiopharmaceutical manufacturing facility, the materials warehouse as well as the laboratory setting.
The facility is operated under well-controlled and closely monitored conditions that are regulated by both State and Federal agencies, and that are enforced by the corporate internal quality and regulatory groups. Each staff memb
Benefits
Health insuranceVision insurance
Additional Information
What Quality Control contributes to Cardinal Health
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.
Cardinalhealth · Indianapolis-theranostics Commercial, IN