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- Tasks: Join us as a Quality Assurance Sr. Specialist, ensuring top-notch quality in pharmaceutical testing.
- Company: Cardinal Health is a leading healthcare services and products company dedicated to improving patient outcomes.
- Benefits: Enjoy medical coverage, paid time off, flexible spending accounts, and a 401k savings plan.
- 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, plus 2-4 years of QA experience in pharmaceuticals.
- Other info: We value diversity and encourage all qualified candidates to apply, including those without a degree.
The predicted salary is between 60000 - 86000 £ per year.
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Quality Assurance Sr. Specialist, Mansfield
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Client:
Cardinal Health
Location:
Mansfield, United Kingdom
Job Category:
Other
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EU work permit required:
Yes
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Job Reference:
9a1281e1b355
Job Views:
2
Posted:
12.07.2025
Expiry Date:
26.08.2025
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Job Description:
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 Assurance review and analyzing data from pharmaceutical stability tests to ensure they meet established quality standards
Review and approve stability studies, trending, and interpretation other relevant documentation to ensure accuracy, compliance, and to assess product for degradation and shelf-life prediction.
Thoroughly review and interpret analytical data generated from tests, identifying any deviations from expected results, quality issues, including out-of-specification results and taking appropriate corrective actions (e/g CAPA) to mitigate risks..
Ensure adherence to Good Laboratory Practices (GLP) regulations, including proper documentation, standard operating procedures (SOPs), and quality control protocols.
Assist QA management, oversee the stability study lifecycle, including protocol
Identify and communicate stability trends, deviations, or out-of-specification results to QA leadership.
Participate in the preparation and execution of regulatory inspections and audits. Participate in internal and external audits to assess quality systems and identify areas for improvement
Perform risk assessments to identify potential quality issues and implement preventive measures.
Stay current with industry regulations, guidelines, and best practices.
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
2-4 years of experience in quality assurance 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, preferred
Experience in technical writing to support writing, review, and approval of quality documents such as procedures, investigations, and audit responses, preferred
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 a plus.
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 Assurance 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.
Work with lab managers of pharmaceutical analysis department, provide inputs for development of instrument testing protocol and methods, standard operating procedures (SOPs), work instructions and other instrument documentation.
Ensures that the necessary testing is performed according to the test specification, test method and working instructions and to ensure testing is completed in a timely and efficient manner.
Review analytical method transfer and validation/verification protocols and reports.
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 minimal direct supervision and with a continuous improvement mind-set.
Anticipated salary range:$75,600 – $108,000
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 salary 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.
To read and review this privacy notice click here
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Quality Assurance Sr. Specialist employer: Cardinal Health
Contact Detail:
Cardinal Health Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Quality Assurance Sr. 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 interviews but also demonstrate your commitment to quality assurance in the pharmaceutical industry.
✨Tip Number 2
Network with professionals in the pharmaceutical field, especially those who work in quality assurance. Attend industry conferences or webinars to connect with potential colleagues and learn about the latest trends and challenges in the sector.
✨Tip Number 3
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 4
Prepare for questions related to Out of Specification (OOS) investigations. Having examples ready from your past experience where you successfully handled OOS results will showcase your problem-solving skills and understanding of regulatory guidelines.
We think you need these skills to ace Quality Assurance Sr. Specialist
Some tips for your application 🫡
Tailor Your CV: Make sure your CV highlights relevant experience in quality assurance, particularly in pharmaceutical or biopharmaceutical environments. Emphasise your knowledge of analytical techniques and regulatory guidelines that align with the job description.
Craft a Strong Cover Letter: Write a cover letter that specifically addresses how your skills and experiences make you a great fit for the Quality Assurance Sr. Specialist role. Mention your familiarity with Good Laboratory Practices (GLP) and any experience with quality management systems.
Highlight Relevant Experience: In your application, focus on your previous roles that involved stability testing, data analysis, and compliance with FDA regulations. Use specific examples to demonstrate your ability to identify and mitigate quality issues.
Proofread Your Application: Before submitting, carefully proofread your CV and cover letter for any spelling or grammatical errors. A polished application reflects attention to detail, which is crucial for a role in quality assurance.
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 you've applied them in previous roles.
✨Understand Regulatory Guidelines
Brush up on ICH guidelines, FDA regulations, and Good Laboratory Practices (GLP). Demonstrating a solid understanding of these regulations will show that you are well-prepared for the role and can ensure compliance.
✨Prepare for Data Analysis Questions
Expect questions related to data analysis and interpretation. Be ready to provide examples of how you've identified deviations or quality issues in past projects and the corrective actions you took.
✨Showcase Your Communication Skills
Since strong communication skills are essential for this role, practice articulating your thoughts clearly. Prepare to discuss how you've effectively communicated findings and collaborated with cross-functional teams in previous positions.
