Senior Specialist, Quality Control Chemist II - Indianapolis - Cardinal Health

Description

Job Summary

We are seeking a Quality Control Specialist to join our team at Cardinal Health. The successful candidate will be responsible for ensuring the quality of products and services, developing and implementing quality policies and procedures, and performing inspections and analysis of materials, components, products, or processes.

Responsibilities:

• 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
• Executes method verification, validation, and/or transfer protocols
• Performs 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
• Gains awareness of other departments at site
• Exhibits professional conduct and respect for others

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 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 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 communication skills

Location: Onsite in Indianapolis, IN

Schedule: 2nd Shift - Typically 2:00 pm - 11:00 pm or 3:00 pm - 12:00 am; potential to work 1st shift to cover PTO of other analysts

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
• While performing the duties of this job, the employee is regularly required to talk or hear, frequently required to stand, walk, use hands to finger, handle, or feel, and reach with hands and arms
• Specific vision abilities required by the job include close vision, distance vision, color vision, peripheral vision, depth perception, and the ability to adjust focus

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

What is Expected of You and Others at This Level:

• This role will perform analysis of Incoming Materials, Drug Substance, In-Process, and Drug Product samples
• This role will execute method verification, validation, and/or transfer protocols
• This position will perform stability testing in alignment with stability protocol(s) at the prescribed cadence
• This position may execute analytical equipment qualification protocols or computer system validation test scripts
• Exhibits Cardinal Health's high ethical standards and code of conduct
• Approaches work situations with a positive and energizing style
• Aligns work priorities with immediate supervisor/management
• Gain awareness of other departments at site
• Exhibit professional conduct and respect for others

Benefits:

• Medical, dental, and vision coverage
• Paid time off (untracked)
• Health savings account (HSA)
• 401(k) savings plan
• Access to wages before payday with myFlexPay
• Flexible spending accounts (FSAs)
• Short- and long-term disability coverage
• Work-Life resources
• Paid parental leave
• Healthy lifestyle programs