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- Tasks: Join us as a Quality Assurance Specialist, ensuring our pharmaceutical products meet top-notch quality standards.
- Company: Cardinal Health is a leading healthcare services and products company dedicated to improving patient outcomes.
- Benefits: Enjoy flexible work options, health coverage, paid time off, and a supportive work-life balance.
- Why this job: Be part of a dynamic team in a state-of-the-art facility, making a real impact on healthcare.
- Qualifications: A degree in chemistry or related field is preferred; experience in quality control is a plus.
- Other info: We celebrate diversity and encourage all qualified candidates to apply, including those without a degree.
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What Chemistry Services Center contributes to Cardinal Health
Chemistry Services Center perform laboratory testing to characterize the chemistries of our medical device products and stability testing for pharmaceutical products of Cardinal Health. Under the umbrella of QRMA, Chem Services develops and executes test protocols utilizing specialized instrumentation and analytical techniques to characterize medical devices, materials, and processing aids for chemical properties of concern or the chemical constituents which may be released when a device is utilized during clinical use. The Chemistry Service will also use specialized instruments to perform Assay and impurity/degradant tests for stability and release testing for solid dose pharmaceutical. Chemistry Services is a part of QRMA Scientific Services.
This role is 100% onsite at our state-of-the-art Scientific Service Center in Mansfield, MA.
Responsibilities
Provide Quality Control review and analyzing data from pharmaceutical stability tests to ensure they meet established quality standards
Thoroughly review analytical data generated from tests, identifying any deviations from expected results, and investigating potential causes.
Ensure adherence to Good Laboratory Practices (GLP) regulations, including proper documentation, standard operating procedures (SOPs), and quality control protocols.
Review and approve stability studies, and other relevant documentation to ensure accuracy and compliance.
Review stability data trending, statistical analysis, and interpretation to assess product degradation and predict shelf-life.
Identify and communicate stability trends, deviations, or out-of-specification results to QA leadership.
Assist QA management, oversee the stability study lifecycle, including protocol
Stay current with industry regulations, guidelines, and best practices.
Assist in the preparation and execution of regulatory inspections and audits.
Qualifications
Bachelor’s degree in chemistry. pharmacy or a related scientific field, preferred or relevant work experience.
Strong knowledge of analytical techniques such as HPLC, GC, UV-Vis, Karl Fisher and dissolution and related instrumentations, preferred
0-2 years of experience in quality control within a pharmaceutical or biopharmaceutical manufacturing or testing environment, preferred
Strong knowledge of ICH guidelines, FDA regulations, Data Integrity, Quality Risk Management and other pharmaceutical regulatory requirements, preferred
Working knowledge of regulatory guidelines of analytical method verification, validation, and method transfer, preferred
Experience with investigations of Out of Specification (OOS) per FDA guidelines a plus.
Experience with quality management systems (e.g., TrackWise, Veeva or Agile), experience with LIMS (e.g., LabWare) is a plus.
Experience with pharmaceutical stability test analysis software for data management is desired.
Ability to prioritize objectives from multiple projects, adhere to scheduled timelines while maintaining flexibility.
Excellent attention to detail and data analysis skills.
Strong communication (both oral and written) and reporting skills.
Ability to work in a fast-paced, cross-functional environment.
What is expected of you and others at this level
Provide Quality Control review and analyzing data from pharmaceutical stability tests to ensure they meet established quality standards
Experience with Quality Management Software (QMS), such as Trackwise, Veeva or Agile and Laboratory Information Management System (LIMS), such as LabWare.
Possesses significant working knowledge of USP, FDA and ICH regulatory requirements as applicable to pharmaceutical stability testing.
Possess a thorough understanding of Good Laboratory Practices (GLP) and Good Manufacturing Practices (GMP) to ensure compliance of systems and procedures.
Work with QA management, establishes, implements, and achieves a Professional Development Plan that maintains the incumbent’s high level of scientific and regulatory knowledge and expertise.
Demonstrated initiative – able to work proactively with direct supervision and with a continuous improvement mind-set.
Anticipated hourly range:$29.30 per hour – $41.90 per hour
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
Application window anticipated to close:8/1/2025 *if interested in opportunity, please submit application as soon as possible.
The hourly range listed is an estimate. Pay at Cardinal Health is determined by multiple factors including, but not limited to, a candidate’s geographical location, relevant education, experience and skills and an evaluation of internal pay equity.
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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.
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Quality Assurance Specialist employer: Cardinal Health
Contact Detail:
Cardinal Health Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Quality Assurance Specialist
✨Tip Number 1
Familiarise yourself with Good Laboratory Practices (GLP) and Good Manufacturing Practices (GMP). Understanding these regulations will not only help you in the interview but also demonstrate your commitment to quality standards in the pharmaceutical industry.
✨Tip Number 2
Brush up on your knowledge of analytical techniques such as HPLC, GC, and UV-Vis. Being able to discuss these methods confidently during your interview can set you apart from other candidates.
✨Tip Number 3
Network with professionals in the pharmaceutical field, especially those who work in quality assurance. They can provide insights into the role and may even refer you to opportunities within their organisations.
✨Tip Number 4
Stay updated on the latest ICH guidelines and FDA regulations. Showing that you are proactive about your professional development can impress potential employers and demonstrate your dedication to the field.
We think you need these skills to ace Quality Assurance Specialist
Some tips for your application 🫡
Tailor Your CV: Make sure to customise your CV to highlight relevant experience in quality control and analytical techniques. Emphasise any familiarity with HPLC, GC, and other methods mentioned in the job description.
Craft a Strong Cover Letter: Write a compelling cover letter that outlines your passion for quality assurance and your understanding of Good Laboratory Practices (GLP). Mention specific experiences that align with the responsibilities listed in the job description.
Highlight Relevant Skills: In your application, clearly showcase your knowledge of ICH guidelines, FDA regulations, and any experience with Quality Management Systems (QMS) or Laboratory Information Management Systems (LIMS).
Proofread Your Application: Before submitting, thoroughly proofread your application for any spelling or grammatical errors. A polished application reflects attention to detail, which is crucial for a Quality Assurance Specialist.
How to prepare for a job interview at Cardinal Health
✨Know Your Analytical Techniques
Familiarise yourself with the analytical techniques mentioned in the job description, such as HPLC, GC, and UV-Vis. Be prepared to discuss your experience with these methods and how they relate to quality control in pharmaceutical testing.
✨Understand Regulatory Guidelines
Brush up on ICH guidelines, FDA regulations, and Good Laboratory Practices (GLP). Showing that you are knowledgeable about these regulations will demonstrate your commitment to compliance and quality assurance.
✨Prepare for Data Analysis Questions
Expect questions related to data analysis and stability testing. Be ready to explain how you would identify trends or deviations in stability data and what steps you would take to investigate any out-of-specification results.
✨Showcase Your Communication Skills
Since strong communication skills are essential for this role, practice articulating your thoughts clearly and concisely. Be prepared to discuss how you would communicate findings to QA leadership and collaborate with cross-functional teams.
