Senior QA Associate - Drug Product Compliance

Kelly Services; Juncos (PR); On-site; USD 41,000 - 47,000; Full time

Benefits offered by this job

medical

dental

vision

telemedicine

term life

whole life

accident insurance

critical illness

a legal plan

short-term disability

retirement savings plan

service bonus

holiday pay plans (earn up to eight)

transit spending account

paid sick leave

Job summary

Kelly Services in the United States is seeking a Senior Associate QA to support QA operations in the East region, Puerto Rico. Responsibilities include sampling plans for drug products, batch record reviews, and overseeing deviations and change controls to ensure quality standards.

The role requires bilingual proficiency in Spanish and English and allows for non-standard shifts including weekends. Salary offered is $30 per hour, with benefits such as medical, dental, vision, and more.

Qualifications

• Bachelor’s degree in Science + 6 months of Quality work experience OR Master’s degree.
• QA Acceptance Sampling Plan Inspection
• Execution/documentation in Electronic Batch Record
• On line Batch Record Review
• Quality Oversight of the Inspection processes
• Knowledge of SAP system
• Experience in batch record review, audit trail reviews and GDP with focus on data integrity (ALCOA+)
• Experience with deviations.
• Fluent in Spanish and English.

Responsibilities

• Sampling plans for all drug products, batch record review, audit the inspection and packaging process ensuring compliance to procedures and Quality standards; oversee QA operations within the facility including on-the-floor QA support, deviation investigations, change controls, and SOP revisions.

Skills

Sampling plan

Batch record review

Deviation investigations

GDP/ALCOA+ data integrity

Quality oversight

SAP knowledge

Bilingual: Spanish/English

Education

Bachelor’s degree in Science + 6 months QA experience OR Master’s degree

Tools

SAP

Job description

Kelly Services in the United States is seeking a Senior Associate QA to support QA operations in the East region, Puerto Rico. Responsibilities include sampling plans for drug products, batch record reviews, and overseeing deviations and change controls to ensure quality standards.

The role requires bilingual proficiency in Spanish and English and allows for non-standard shifts including weekends. Salary offered is $30 per hour, with benefits such as medical, dental, vision, and more.