QA Specialist
QA Specialist
Posted on :
27-08-2025
Employer Active
1 Vacancy
Job Alert
You will be updated with latest job alerts via emailValid email field required
Send jobs
Share
Send me jobs like this
Job Alert
You will be updated with latest job alerts via emailValid email field required
Send jobs
Job Description
Summary:
We are seeking a detail-oriented and proactive QA Specialist to join our dynamic biotechnology team. This role is critical in ensuring compliance with regulatory standards and internal quality systems particularly in areas involving change control aseptic manufacturing and validation activities. The ideal candidate will bring hands-on experience in GMP environments and contribute to continuous improvement initiatives across the organization.
Main Responsibilities:
We are seeking a detail-oriented and proactive QA Specialist to join our dynamic biotechnology team. This role is critical in ensuring compliance with regulatory standards and internal quality systems particularly in areas involving change control aseptic manufacturing and validation activities. The ideal candidate will bring hands-on experience in GMP environments and contribute to continuous improvement initiatives across the organization.
Main Responsibilities:
- Oversee and manage change control processes ensuring timely review impact assessment and implementation in accordance with regulatory and internal requirements.
- Support and monitor aseptic processing operations including routine audits environmental monitoring reviews and contamination control strategies.
- Lead and/or support validation activities (equipment process cleaning and computerized systems) including protocol development execution and final reporting.
- Review and approve quality documentation such as SOPs batch records deviations CAPAs and validation protocols.
- Collaborate cross-functionally with Manufacturing Engineering Regulatory Affairs and R&D to ensure quality objectives are met.
- Participate in internal and external audits including regulatory inspections (FDA EMA etc.) and support audit readiness.
- Analyze quality metrics and trends to identify areas for improvement and drive corrective/preventive actions.
- Maintain current knowledge of applicable regulations standards and industry best practices (e.g. FDA ICH ISO EU GMP).
- Education:Bachelors degree in ScienceEngineering or related life sciences field.
- Experience:Minimum 35 years in QA roles within biotechnology pharmaceutical or medical device industries.
- Strong knowledge of GMP aseptic techniques change control systems and validation lifecycle.
- Excellent written and verbal communication skills; bilingual proficiency (English/Spanish) is a plus.
- Analytical mindset attention to detail problem-solving ability and collaborative spirit.
- Professional services contract
- Full time
- Administrative shift with availability to support non administrative hours
- 6-12 months of first contract with potential extensions based on performance and budget
- Languages: Spanish and English
- Location: Juncos PR
Required Experience:
Unclear Seniority
Employment Type
Full Time
Report This Job
Disclaimer: Drjobpro.com is only a platform that connects job seekers and employers. Applicants are advised to conduct their own independent research into the credentials of the prospective employer.We always make certain that our clients do not endorse any request for money payments, thus we advise against sharing any personal or bank-related information with any third party. If you suspect fraud or malpractice, please contact us via contact us page.
