Sr. Spec. Quality Assurance

Cardinal Health; Denver (CO); On-site; USD 69,000 - 88,000; Full time

Benefits offered by this job

Medical, dental and vision coverage

Paid time off plan

Health savings account

401k savings plan

Access to wages before pay day with my

FSAs

Disability coverage

Work-Life resources

Paid parental leave

Healthy lifestyle programs

Job summary

Cardinal Health is seeking a Senior Specialist, Quality Assurance to execute quality programs and policies in a specialty area, such as recalls and customer complaints. You will support the Manager, QA in audits, develop insights, and mentor junior Specialists, potentially leading SOP development in assigned areas.

With 2–4 years of QA and a GMP background, you will help ensure compliance, drive risk mitigation, and contribute to scalable quality systems across manufacturing and distribution

Qualifications

• 2-4 years of experience in quality assurance
• BA, BS or equivalent education and experience combination in related field preferred
• Combination of GMP experience and manufacturing experience
• Comprehensive knowledge of cGMPs, 21 CFR 11, 210, 211 and 820
• Proficient with electronic quality management systems; Veeva Vault is a plus
• Comprehensive knowledge of pharmaceutical manufacturing and packaging processes

Responsibilities

• Ensures fulfillment of external reporting requirements related to area of specialty, such as submitting materials for product recalls.
• Apply knowledge of GMP regulations and manufacturing processes to drive compliance and mitigate risk.
• Investigate customer complaints and support quality investigations.
• Contribute to monthly quality metrics reporting.
• Authors or updates standard operating procedures (SOPs).
• Guide internal stakeholders on adherence to QA policies and procedures and regulatory requirements.
• Support change control processes and assess QA implications of product changes.
• Update SOPs in response to changes and regulatory developments.
• Prepare responses to regulatory audits and corporate audits.
• Provide guidance to junior Specialists and assist with onboarding trainings.
• Coordinate quality audits and inspections at distribution centers as needed.

Skills

GMP experience

cGMPs knowledge

Regulatory knowledge

Quality metrics

Education

BA/BS or equivalent education

Tools

Veeva Vault

Job description

What Quality Assurance 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 Assurance develops and implements a compliant and cost effective quality system that assures products and services are reliable, safe and effective. This job family provides oversight of production/manufacturing activities, training to operational and quality control personnel, and educates business leaders on Quality policies and procedures and ensures that all products and services are properly reviewed for quality and documented.

Job Summary

The Senior Specialist, Quality Assurance executes quality programs, policies, and procedures in a particular area of specialty (such as recalls and customer complaints) in order to minimize risks and drive supply chain integrity. Applying knowledge of quality assurance concepts and technical capabilities, the Senior Specialist supports the Manager, Quality Assurance in quality audits and develops actionable insights and recommendations for addressing complex quality issues. Due a higher level of experience and knowledge, the Senior Specialist mentors junior Specialists and, under the guidance of the Manager, may lead the development of standard operating procedures in assigned specialized area.

Responsibilities

• Ensures fulfillment of external reporting requirements related to area of specialty, such as submitting necessary materials for product recalls. Submits reports for internal review prior to submission to regulatory bodies.


• Apply knowledge of GMP regulations and manufacturing processes to drive compliance, support operational excellence, and mitigate risk.


• Customer Complaint Investigations


• Supporting Monthly Metrics


• Authors or updates standard operating procedures


• Executes internal programs to define Quality guidelines and track adherence to these guidelines. Provides guidance to internal stakeholders regarding adherence to internal Quality Assurance policies and procedures as well as external requirements.


• Responds to significant quality issues and in support of the Manager, conducts root cause analyses, reports on relevant quality metrics and trends, and develops insights for internal stakeholders. Collaborates with Quality Assurance Specialists in other specialty areas as necessary to develop recommendations.


• Supports of the Change Control Program, by assessing Quality Assurance implications and impacts of operational and product changes, with a focus on specialty area.


• Updates standard operating procedures in response to product changes and regulatory developments under the general guidance of the Manager. Resolutions to significant quality issues, such as recalls or customer complaints, may set precedent for updates to SOPs.


• Prepares responses to regulatory queries, regulatory audits, and corporate audits and gathers necessary information from products and operations stakeholders.


• Supports the Manager, Quality Assurance in quality audits and inspections of distribution centers within the region. Records quality issues and provides draft reports and insights to the Manager, for delivery to the Operations stakeholders.


• Provides guidance to junior level Specialists on complex issues, assists with onboarding trainings, and frequently reviews the work of Specialists prior to delivery to a Manager.

Qualifications

• 2-4 years of experience, preferred


• BA, BS or equivalent education and experience combination in related field preferred


• Combination of GMP experience and manufacturing experience


• Comprehensive knowledge of cGMPs, 21 CFR 11, 210, 211 and 820.


• Proficient with electronic quality management systems. Experience with Veeva Vault is a plus.


• Comprehensive knowledge and familiarity with products, processes, equipment, and facilities of pharmaceutical manufacturing and packaging.

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: $68,500 – $88,020

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

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.

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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