Senior Specialist, Quality Control Chemist II
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.
- 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 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.
- Bachelor’s degree in a scientific field preferred or previous work experience in a similar role or related field preferred
- 2+ years of relevant work experience working with 21 CFR 210, 211 in the FDA regulated industry (Pharmaceutical or Medical Device) preferred.
- Has willingness to author a variety of forms of documentation such as SOPs, Change Controls, CAPAs, Deviations and Laboratory Investigations.
- Has general knowledge of GDP documentation practices and requirements
- Must work well with others and understand how to be successful in a team environment.
- Detail oriented, organized, able to multitask, a self-starter, and self-motivated.
- 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.
- Onsite in Indianapolis, IN
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. The employee is frequently required to stand; walk; use hands to finger, handle or feel; and reach with hands and arms; balance; stoop, kneel, crouch or crawl; talk or hear; and taste or smell. The employee must occasionally lift or move up to 25 pounds. Specific vision abilities required by the job include close vision, distance vision, color vision, peripheral vision, depth perception and the ability to adjust focus.
What is expected of you and others at this level
- Applies working knowledge in the application of concepts, principles and technical capabilities to perform varied tasks
- Works on projects of moderate scope and complexity
- Identifies possible solutions to a variety of technical problems and takes action to resolve
- Applies judgment within defined parameters
- Receives general guidance and may receive more detailed instruction on new projects
- Work reviewed for sound reasoning and accuracy
Anticipated salary range: $66,500-$95,000
Bonus eligible: No
Benefits: Cardinal Health offers a wide variety of benefits and programs to support health and well-being.
- Medical, dental and vision coverage
- Paid time off plan
- Health savings account (HSA)
- 401k savings plan
- Access to wages before pay day with myFlexPay
- Flexible spending accounts (FSAs)
- Short- and long-term disability coverage
- Work-Life resources
- Paid parental leave
- Healthy lifestyle programs
Application window anticipated to close: 04/08/2024 *if interested in opportunity, please submit application as soon as possible.
Candidates who are back-to-work, people with disabilities, without a college degree, and Veterans are encouraged to apply.
Cardinal Health supports an inclusive workplace that values diversity of thought, experience and background. We celebrate the power of our differences to create better solutions for our customers by ensuring employees can be their authentic selves each day. Cardinal Health is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, ancestry, age, physical or mental disability, sex, sexual orientation, gender identity/expression, pregnancy, veteran status, marital status, creed, status with regard to public assistance, genetic status or any other status protected by federal, state or local law.
To read and review this privacy notice click here