At a Glance
- Tasks: Lead the QA/QC department, ensuring quality standards in pharmaceutical testing.
- Company: Join Cardinal Health, a leader in healthcare solutions and innovation.
- Benefits: Enjoy medical coverage, paid time off, flexible spending accounts, and more!
- Why this job: Make an impact in healthcare while working in a dynamic, supportive environment.
- Qualifications: Bachelor's degree in chemistry or related field; 8-12 years of QA experience preferred.
- Other info: Diversity is celebrated here; all backgrounds are encouraged to apply!
The predicted salary is between 80000 - 120000 £ per year.
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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 Quality, Regulatory & Medical Affairs (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
Manage department operations and supervise QA/QC department.
Develop and maintain quality assurance procedures, policies, and systems
Create laboratory KPIs (Key Performance Indicators) to ensure effectiveness of quality system and efficiency of the lab operations
Provide Quality Assurance review and analysis of data from pharmaceutical stability tests to ensure they meet established quality standards
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.
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.
Assist 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.
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.
8-12 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 submission and approval of laboratory accreditations (e.g. ISO 17025), preferred.
Ability to support regulatory inspection including audit readiness and responses, preferred.
Experience with investigations of Out of Specification (OOS) per FDA guidelines, 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, preferred.
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
Manage the day-to-day operations of the QA/QC department supporting Chemical Characterization of Medical Devices and Pharmaceutical Stability testing.
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.
Help develop 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 no direct supervision and with a continuous improvement mind-set.
Anticipated salary range:$115,900 – $173,800
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.
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Quality Assurance Manager employer: Cardinal Health
Contact Detail:
Cardinal Health Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Quality Assurance Manager
✨Tip Number 1
Familiarise yourself with the specific analytical techniques mentioned in the job description, such as HPLC and GC. Being able to discuss your hands-on experience with these methods during an interview can set you apart from other candidates.
✨Tip Number 2
Understand the regulatory landscape, particularly ICH guidelines and FDA regulations. Showing that you are well-versed in these areas will demonstrate your readiness for the role and your ability to navigate compliance effectively.
✨Tip Number 3
Prepare to discuss your experience with Quality Management Systems (QMS) and Laboratory Information Management Systems (LIMS). Highlighting your familiarity with software like TrackWise or LabWare can give you an edge in the interview process.
✨Tip Number 4
Showcase your leadership skills by preparing examples of how you've managed teams or projects in the past. This role involves supervising the QA/QC department, so demonstrating your ability to lead effectively will be crucial.
We think you need these skills to ace Quality Assurance Manager
Some tips for your application 🫡
Tailor Your CV: Make sure your CV highlights relevant experience in quality assurance, particularly within pharmaceutical or biopharmaceutical environments. Emphasise your knowledge of analytical techniques and regulatory guidelines that align with the job description.
Craft a Strong Cover Letter: In your cover letter, express your passion for quality assurance and how your background makes you a perfect fit for the role. Mention specific experiences that demonstrate your ability to manage QA/QC operations and your familiarity with Good Laboratory Practices (GLP).
Highlight Key Skills: Clearly outline your skills related to data analysis, communication, and project management. Use examples from your past roles to illustrate how you've successfully implemented quality assurance procedures and handled regulatory inspections.
Proofread Your Application: Before submitting, thoroughly proofread your application materials. Check for any spelling or grammatical errors, and ensure that all information is accurate and clearly presented. A polished application reflects your attention to detail, which is crucial for this role.
How to prepare for a job interview at Cardinal Health
✨Know Your Quality Assurance Fundamentals
Make sure you have a solid understanding of quality assurance principles, especially in the pharmaceutical context. Be prepared to discuss Good Laboratory Practices (GLP), Good Manufacturing Practices (GMP), and relevant regulatory guidelines like ICH and FDA regulations.
✨Demonstrate Analytical Expertise
Familiarise yourself with analytical techniques such as HPLC, GC, and UV-Vis. Be ready to explain how you've used these methods in past roles, particularly in relation to stability testing and data analysis.
✨Showcase Your Problem-Solving Skills
Prepare examples of how you've identified and resolved quality issues in previous positions. Discuss your experience with Out of Specification (OOS) investigations and how you implemented corrective actions to mitigate risks.
✨Communicate Effectively
Strong communication skills are essential for this role. Practice articulating your thoughts clearly and concisely, both verbally and in writing. Be ready to discuss how you’ve collaborated with cross-functional teams to achieve quality objectives.