Chemical/Pharmaceutical, Quality Assurance (NIGHTS)

Cardinal Health; San Antonio (TX); In loco; USD 69.000 - 88.000; Tempo pieno

Vantaggi offerti da questo lavoro

Medical, dental and vision coverage

Paid time off plan

401k savings plan

myFlexPay access to wages before pay

FSAs

Short- and long-term disability

Work-Life resources

Paid parental leave

Healthy lifestyle programs

Descrizione del lavoro

Cardinal Health PET Manufacturing Services is seeking a Quality Assurance professional to support CGMP documentation review and product release processes. You will work with operations to uphold CGMP standards and drive continuous improvement in quality systems.

The role requires a Bachelor’s degree in Science, strong English communication, and familiarity with regulated environments; pharma or medical device experience is a plus. This position is on-site with comprehensive benefits.

Competenze

• Effective written and verbal English communication skills required.
• 0-2 years' experience in a regulated environment preferred.
• Pharmaceutical or medical device experience a plus.
• ISO experience a plus.
• Quality Assurance background preferred.

Mansioni

• CGMP documentation review related to product release, facilities and equipment, material controls, laboratory controls, packaging and labeling, and production & process controls.
• Establish and report metrics related to products and processes as deemed necessary by the RQM.
• Ensure the site manufactures products to meet CGMP requirements.

Conoscenze

English communication

Regulated environment experience

Pharma/medical device experience

ISO experience

Quality Assurance background

Formazione

Bachelor's degree in Science

Descrizione del lavoro

Cardinal Health PET Manufacturing Services

Cardinal Health PET Manufacturing Services is responsible for manufacturing PET radiopharmaceuticals to enhance patient treatment through improved disease diagnosis, staging, and monitoring.

What Quality Assurance contributes to Cardinal Health

Quality Assurance is responsible for developing and implementing a compliant and cost effective quality system that assures products and services are reliable, safe and effective. Demonstrates knowledge of quality systems and approaches. Demonstrates an understanding of the relevant regulations, standards and operating procedures. Demonstrates ability to perform investigations / root cause analysis and develop corrective actions. Demonstrates an understanding of the requirements and has the ability to perform gap assessments to those requirements. Demonstrates an understanding of quality concepts such as: cost of quality, analytical metrics and / or statistics, trending, quality planning, validation, CAPA and problem solving. Works cross-functionally and has the ability to interpret the requirements as well as educate and influence others on those requirements.

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 actions to resolve. Applies judgment within defined parameters. Receives general guidance; may receive more detailed instruction on new projects. Work reviewed for sound reasoning and accuracy.

Accountabilities in this role

Quality Assurance responsibilities include but are not limited to CGMP documentation review related to product release, facilities and equipment, material controls, laboratory controls, packaging and labeling, and production & process controls. Establish and report metrics related products and processes as deemed necessary by the RQM. Ensure the site manufactures products to meet the requirements of 21 CFR 212 (CGMP). Responsible for the quality of documentation (control, retention, and archival) to support CGMP activities. Engage and collaboration with operations department to drive quality system and CGMP requirements. Responsible for product release activities per CGMP requirements. Responsible for reporting quality system issues to the regional RQM. This includes timely escalation of discrepancies upon identification.

Qualifications

• Bachelor's of Science degree preferred
• Effective written and verbal English communication skills required
• 0-2 years' experience in a regulated environment preferred
• Pharmaceutical or medical device experience a plus
• ISO experience a plus
• Quality Assurance background preferred

Lifting

• Frequent lifting between 50-75 lbs
• Ability to manage several tasks at the same time
• Ability to focus on tasks
• Ability to evaluate operating conditions
• Ability to exercise sound judgment

Personal Protective Equipment

Must be able to work night shift. roughly 9pm - 9am (give or take a few hours - 8 hour shift) Sunday - Friday

Salary

Anticipated salary range: $68,500.00-$88,020.00

Bonus eligible: No

Benefits

• 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

12/5/2025

Diversity and Equal Opportunity

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 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.

Company Overview

Headquartered in Dublin, Ohio, Cardinal Health, Inc. (NYSE: CAH) is a distributor of pharmaceuticals, a global manufacturer and distributor of medical and laboratory products, and a provider of performance and data solutions for healthcare facilities. We are a crucial link between the clinical and operational sides of healthcare, delivering end-to-end solutions and data-driven insights that advance healthcare and improve lives every day. With deep partnerships, diverse perspectives and innovative digital solutions, we build connections across the continuum of care. With more than 50 years of experience, we seize the opportunity to address healthcare's most complicated challenges - now, and in the future.