Senior QA Associate, Drug Product Quality & Compliance

Kelly Services; USA; Vor Ort; USD 70.000 - 95.000; Vollzeit

Benefits dieser Stelle

Medical insurance

Dental insurance

Vision insurance

Telemedicine

Life insurance

Critical illness coverage

Legal plan

Short-term disability

Retirement savings plan

Service bonus

Holiday pay

Transit spending account

Paid sick leave

Zusammenfassung

Kelly Science & Clinical seeks a Sr Associate QA in Puerto Rico to support QA operations, batch record review, and deviation investigations in aseptic drug manufacturing. The role emphasizes data integrity (ALCOA+) and adherence to GDP, with experience in MES systems such as Veeva, LIMS, and PasX.

Fluency in Spanish and English is required, and weekend/12‑hour shifts are possible. The selected candidate will perform sampling plans, oversee on-the-floor QA activity, and help revise SOPs to ensure

Qualifikationen

• QA experience in plant aseptic areas with focus on controls and data integrity (ALCOA+)
• Experience in batch record review and audit trail reviews
• Familiarity with deviations and change controls
• Documentation and MES systems experience (Veeva, LIMS, PasX)
• Fluent in Spanish and English
• Willingness to work non-standard shifts including weekends and holidays

Aufgaben

• Perform sampling plans for drug products and batch record review
• Audit inspections and packaging processes for compliance
• Oversee QA operations on the floor, deviation investigations, and SOP revisions
• Support data integrity and regulatory compliance across QA activities

Kenntnisse

Quality assurance (QA)

Aseptic manufacturing

GMP/GDP

Deviation investigations

Batch record review

Documentation/records

Veeva LIMS PasX

Bilingual Spanish/English

Shift work

Ausbildung

Associates degree or higher

0-2 years quality experience (as per ad)

Bachelor's degree (optional)

Tools

Veeva

LIMS

PasX

Jobbeschreibung

Kelly Science & Clinical seeks a Sr Associate QA in Puerto Rico to support QA operations, batch record review, and deviation investigations in aseptic drug manufacturing. The role emphasizes data integrity (ALCOA+) and adherence to GDP, with experience in MES systems such as Veeva, LIMS, and PasX.

Fluency in Spanish and English is required, and weekend/12‑hour shifts are possible. The selected candidate will perform sampling plans, oversee on-the-floor QA activity, and help revise SOPs to ensure