Senior QA Specialist – Night Shift (CGMP & Compliance)

Cardinal Health, Inc.; Denver (CO); Presencial; CAD 108 000 - 139 000; Tempo integral

Vantagens oferecidas por esta oferta de emprego

Medical, dental and vision coverage

Paid time off

Health savings account (HSA)

401k savings plan

MyFlexPay access

Flexible spending accounts (FSAs)

Disability coverage

Work-Life resources

Paid parental leave

Healthy lifestyle programs

Resumo da oferta

Cardinal Health PET Manufacturing Services in Denver, CO is seeking a Quality Assurance professional to ensure CGMP-compliant product release, document controls, and cross-functional quality support. The role emphasizes investigation, CAPA, and rapid problem resolution within a regulated radiopharmaceutical setting.

Ideal candidates have 1–2 years QA/regulatory experience, ISO exposure, and strong English communication.

Qualificações

• Bachelor's of Science in Chemistry or Biology degree preferred.
• Effective written and verbal English communication skills required.
• 1-2 years experience in QA and/or regulated environment highly preferred - cGMP
• Pharmaceutical or medical device experience a plus
• ISO experience a plus
• Quality Assurance background preferred
• Lifting: Frequent lifting between 50-75 lbs

Responsabilidades

• Applies working knowledge to perform varied QA 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.
• Quality assurance responsibilities include CGMP documentation review relating 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.
• Responsible for the quality of documentation (control, retention, and archival) to support CGMP activities
• Engage and collaborate 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, including timely escalation of discrepancies

Conhecimentos

Night shift

English communication

QA experience

CGMP knowledge

ISO experience

Quality Assurance background

Lifting 50-75 lbs

Formação académica

Bachelor’s of Science in Chemistry or Biology

Descrição da oferta de emprego

Cardinal Health PET Manufacturing Services in Denver, CO is seeking a Quality Assurance professional to ensure CGMP-compliant product release, document controls, and cross-functional quality support. The role emphasizes investigation, CAPA, and rapid problem resolution within a regulated radiopharmaceutical setting.

Ideal candidates have 1–2 years QA/regulatory experience, ISO exposure, and strong English communication.