Kelly Services
Location
Puerto Rico | United States
Job description
2023 Science Template
Kelly® Science & Clinical is seeking Specialist QA for a 5 month contract position at a Global Pharmaceutical & Biotechnology client in Juncos, Puerto Rico. If you’re passionate about bringing the latest scientific discoveries to life and are ready to take the next step in your career, trust The Experts at Hiring Experts.
Salary: $38.00 per/hour
Overview
This client is Global Biopharmaceutical company whose mission is to discover, develop and deliver innovative medicines that help patients prevail over serious diseases.
In this role you’ll be responsible for perform review, approval and tracking of cGMP processes, procedures, testing (methods) in manufacturing, documents and records, batch record review, MES, EBR, SAP, Trackwise; including but not limited to Deviation’s, CAPAs, and validations.
This role will give you an opportunity to transform patients’ lives through science by contribute with a global leading biopharma company powered by talented individuals who drive scientific innovation.
Schedule: 1 st , 2 nd and 3 rd shift
Rotating shifts 12 hours (5 pm to 5 am to 5 am to 5 pm), weekends and holidays
Responsibilities:
Actively engage in Continues Improvement initiatives, programs and projects
Vigilant ensuring that changes that could potentially impact product quality are assessed according to procedures
Certify that deviations from established procedures are investigated and documented per procedures
Ensures that production records and testing results are complete, accurate, and documented according to written procedures and cGMP requirements
Provides support and oversight of New Product Introduction (NPI)
Supports internal/external audits and inspections as part of the audit/inspection management team including acting as Quality unit representative as needed
Qualifications:
Doctorate degree or Master's degree and 3 years of directly related experience or Bachelor's degree and 5 years of directly related experience or Associate's degree and 10 years of directly related experience.
Validated expertise in Quality Systems such as Non-Conformance, CAPA, and Change Control
Experience in computer systems validation or computer systems quality assurance (medical device and/or consulting background Technical proficiency)
Robust knowledge of and experience with processes involved in manufacturing and distribution, QA, QAL, and Process Development
Experience with Validation of GxP applications, Validation Master Plan, Installation Qualification (IQ), Risk Assessment/GxP assessment, Operational Qualification (OQ), and Performance Qualification (PQ) Protocols, Test Scripts, and Completion/Summary Reports approvals as per the compliance requirements
Robust knowledge of and experience with processes involved in manufacturing and distribution, QA, QAL, and Process Development.
Validated experience as Quality Contact for complex projects involving packaging, inspection, and new products
What happens next:
Once you apply, you’ll proceed to next steps if your skills and experience look like a good fit. But don’t worry – even if this position doesn’t work out, you’re still in our network. That means our team of expert Science & Clinical recruiters will have access to your profile, making your opportunities limitless.
As part of our promise to talent, Kelly supports those who work with us through a variety of benefits, perks, and work-related resources. Kelly offers eligible employees voluntary benefit plans including medical, dental, vision, telemedicine, term life, whole life, accident insurance, critical illness, a legal plan, and short-term disability. As a Kelly employee, you will have access to a retirement savings plan, service bonus and holiday pay plans (earn up to eight paid holidays per benefit year), and a transit spending account. In addition, employees are entitled to earn paid sick leave under the applicable state or local plan. Click here ( for more information on benefits and perks that may be available to you as a member of the Kelly Talent Community.
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