Specialist QA 34374
Specialist QA 34374
Posted on :
15-06-2025
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
Inteldot has over 14 years in the life sciences industry with allocations across Puerto Rico the United States Europe and Japan. This is a great opportunity for one of our leading clients in Puerto Rico.
Administrative Shift
Job Description
Under minimal supervision perform one or more of the following duties and/or responsibilities in support of the Quality Assurance Program for sophisticated projects involving new drug substance/products.
Requirements:
- Expertise in Quality Systems such as Deviations (Non-conformities CAPA and Change Control).
- Hands on experience in electronic systems for instance: Documentation platforms (CDOCS) Maximo Trackwise LIMS electronic batch record (MES) and SAP.
- 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.
- Validated experience as Quality Contact for sophisticated projects involving new drug substance/products with experience in commissioning and qualifications.
- Enhanced skills in leading influencing and negotiating with the ability to interact with regulatory agencies and evaluate compliance issues.
- Strong communication (both written and oral) facilitation and presentation skills. Fully Bilingual in English and Spanish.
General Functions:
- Review and approve product MPs.
- Approve process validation protocols and reports for manufacturing processes.
- Request Quality on incident triage team.
- Approve planned incidents.
- Represent QA on NPI team.
- Lead investigations and audits.
- Own site quality program procedures.
- Review and approve EMS/BMS alarms.
- Approve NC investigations and CAPA records.
- Approve change controls.
Education
- Doctorate or Masters 2 years of directly related experience or Bachelors 4 years of directly related experience (Life Sciences or Engineering)
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.
