Radiopharma Quality Assurance Specialist (Night Shift)

Regulatory Jobs; San Antonio (TX); 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 (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 is seeking a Quality Assurance professional to ensure CGMP compliance in product release and related activities. The role emphasizes documentation control, cross-functional collaboration with operations, and adherence to 21 CFR 212 CGMP standards.

The ideal candidate has strong English communication, a quality assurance background, and flexibility for a night shift (9pm–9am) with weekend considerations. Competitive benefits apply.

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.
• Must be able to lift 50–75 lbs frequently.
• Night shift: roughly 9pm–9am, Sun–Fri.

Responsibilities

• 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 the requirements of 21 CFR 212 (CGMP).
• Responsible for the quality of documentation (control, retention, and archival) to support CGMP activities.
• Engage with operations to drive quality system and CGMP requirements.
• Responsible for product release activities per CGMP requirements.
• Report quality system issues to the regional RQM and escalate discrepancies promptly.

Skills

Quality systems

Regulatory knowledge

Investigations

CAPA

Quality metrics

Education

Bachelor's degree (BS) preferred

Job description

Cardinal Health PET Manufacturing Services is seeking a Quality Assurance professional to ensure CGMP compliance in product release and related activities. The role emphasizes documentation control, cross-functional collaboration with operations, and adherence to 21 CFR 212 CGMP standards.

The ideal candidate has strong English communication, a quality assurance background, and flexibility for a night shift (9pm–9am) with weekend considerations. Competitive benefits apply.