English
French
Spanish
Senior Specialist QA
Juncos, PR, US
Information Technology
Bachelors Degree
Full Time, Temporary
48.00
Experienced (Non-Manager)
On-site
Biotechnology/Pharmaceuticals
First Shift (Day)
Juncos, PR, US
48.00
Experienced (Non-Manager)
Full Time, Temporary
Biotechnology/Pharmaceuticals
On-site
Information Technology
Bachelors Degree
First Shift (Day)
Job details
At Kelly® Science, we’re passionate about helping you find a job that works for you.
We’re seeking Senior Specialist QA to work for one of our top biotechnology industry clients at Juncos, PR.
Salary: $48.00 hr
Shift: 8hrs shift | Administrative – with work schedule flexibility as required to support 24/7 operations, requiring occasional after-hours engineering coverage.
Why you should apply to be Senior Specialist QA:
- Competitive pay rate and opportunity for professional growth
- Work with a leading organization in the manufacturing sector
- Engage in diverse, impactful engineering projects
- Contribute to a culture of safety, innovation, and operational excellence
- Bi-Weekly pay by W-2
- Vacations, Sick & Holidays paid*
- Christmas bonus*
This job might be an outstanding fit if you have the following qualifications:
- Doctorate with 2+ years, Master’s with 4+ years, or Bachelor’s with 6+ years of directly related Quality Assurance, Validation, or Manufacturing experience.
- Strong knowledge of GMP regulations, Good Documentation Practices, Data Integrity, Quality Systems, Change Control, Risk Management, and validation lifecycle activities.
- Experience supporting manufacturing processes, process validation, equipment qualification, facilities/utilities commissioning and qualification, and Computer System Validation (CSV).
- Demonstrated ability to lead investigations, assess compliance issues, perform risk assessments, and drive effective corrective and preventive actions (CAPAs).
- Experience working with quality and manufacturing systems including KNEAT, CDOCS, SCADA, TrackWise, Maximo, or similar platforms.
- Strong leadership, project management, communication, and cross-functional collaboration skills, with the ability to influence stakeholders and interact with regulatory agencies.
- Strong technical documentation, written and verbal communication skills (English & Spanish)
The Senior Specialist QA serves as the Quality Assurance technical lead, providing oversight and approval of manufacturing processes, validation activities, investigations, and quality systems. Partner with cross-functional teams to ensure GMP compliance, support new product introductions, manage quality risks, and drive continuous improvement across manufacturing operations. Designs, monitors or conduct experimental strategies. Provides data analysis and interpretation and assesses impact of the data on the project. Review and approve manufacturing processes, validation protocols and reports, environmental characterization reports, planned incidents, and sanitary utility system releases while ensuring compliance with GMP requirements. Lead quality investigations, represent QA on cross-functional teams and governance boards, support new product introductions, and maintain site quality programs and procedures.
Helping you discover what’s next in your career is what we’re all about, so let’s get to work.
Apply to be a Senior Specialist QA today!
Lilly Abouomar 9395454792
#Kelly80 #SETTPuertoRico #QA #biotechnology
10395525
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