Sr Specialist QA
QRC GroupJuncos, Puerto Rico
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Overview
Schedule
Full-time
Career level
Senior-level
Remote
On-site
Job Description
We are seeking a Senior QA Specialist with proven experience in the review and approval of documentation related to syringe packaging inspection lines. The ideal candidate will have hands-on experience supporting commissioning and qualification activities, equipment validation, and quality systems compliance within a regulated bio-pharma environment.
Preferred qualifications include experience with Kneat (validation software), Maximo, and CDocs platforms. The successful candidate will possess a strong understanding of Quality Risk Assessments (QRAES), Good Documentation Practices (GDP), Change Control processes, Standard Operating Procedures (SOPs), and applicable GMP requirements. Excellent document management, compliance oversight, and cross-functional collaboration skills are essential.
Requirements
- Education: Doctorate + 2 years of directly related experience or; Masters + 4 years of directly related experience or Bachelors + 6 years of directly related experience or Associates + 10 years of directly related experience or; High school/GED + 12 years of directly related experience.
- Bilingual (English & Spanish)
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FAQs About Sr Specialist QA Jobs at QRC Group
What is the work location for this position at QRC Group?
This job at QRC Group is located in Juncos, Puerto Rico, according to the details provided by the employer. Some roles may also include multiple work locations depending on the requirement.
What pay range can candidates expect for this role at QRC Group?
Employer has not shared pay details for this role.
What employment applies to this position at QRC Group?
QRC Group lists this role as a Full-time position.
What experience level is required for this role at QRC Group?
QRC Group is looking for a candidate with "Senior-level" experience level.
What is the process to apply for this position at QRC Group?
You can apply for this role at QRC Group either through Sonara's automated application system, which helps you submit applications 10X faster with minimal effort, or by applying manually using the direct link on the job page.