Night-Shift Quality Assurance & CGMP Specialist

Cardinal Health; East Hartford (CT); On-site; USD 77,000 - 99,000; Full time

Benefits offered by this job

Medical, dental and vision coverage

Paid time off

Health savings account (HSA)

401k savings plan

Access to wages before pay day with my

Flexible spending accounts (FSAs)

Disability coverage

Work-Life resources

Paid parental leave

Healthy lifestyle programs

Job summary

Cardinal Health PET Manufacturing Services seeks a Quality Assurance professional to support CGMP documentation review for product release, facilities and controls. You will work across operations to ensure compliant manufacturing and timely product release, with attention to quality system improvements.

The role demands strong English communication and a foundational understanding of quality concepts in a regulated environment.

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.

Responsibilities

• Quality Assurance responsibilities include 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.

Skills

Quality systems

Regulations

Root cause analysis

CAPA

Quality metrics

Cross-functional collaboration

GxP knowledge

Education

Bachelor's degree preferred

Job description

Cardinal Health PET Manufacturing Services seeks a Quality Assurance professional to support CGMP documentation review for product release, facilities and controls. You will work across operations to ensure compliant manufacturing and timely product release, with attention to quality system improvements.

The role demands strong English communication and a foundational understanding of quality concepts in a regulated environment.