JT619 - SPECIALIST QA
Juncos, PR · On-site
Serve as QA Manager designee on the local Change Control Review Board (CCRB) * Review and approve ... Manufacturing and laboratory experience required * Demonstrated expertise in GMP documentation ...
JT619 - SPECIALIST QA
Juncos, PR · On-site
Serve as QA Manager designee on the local Change Control Review Board (CCRB) * Review and approve ... Manufacturing and laboratory experience required * Demonstrated expertise in GMP documentation ...
PR · On-site
Review batch, laboratory and production records to assure completeness, accuracy and conformance ... Notify facility manager if any recall necessary to assure that recalled materials are not ...
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PR · On-site
Review batch, laboratory and production records to assure completeness, accuracy and conformance ... Notify facility manager if any recall necessary to assure that recalled materials are not ...
PR · On-site
Coordinate with impacted areas including the laboratory, utilities, and manufacturing operations ... Provide QA assistance and feedback to utilities and operational staff. Inspection Readiness ...
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PR · On-site
Coordinate with impacted areas including the laboratory, utilities, and manufacturing operations ... Provide QA assistance and feedback to utilities and operational staff. Inspection Readiness ...
Specialist QA 35615
Juncos, PR · On-site
... laboratory bench equipment experience (IOQ, PQ, Functional Test). * Technical Writing * Quality ... Designee for QA manager on local CCRB. * Review Risk Assessments. * Support Automation activities.
Specialist QA 35615
Juncos, PR · On-site
... laboratory bench equipment experience (IOQ, PQ, Functional Test). * Technical Writing * Quality ... Designee for QA manager on local CCRB. * Review Risk Assessments. * Support Automation activities.
PR · On-site
Manages the Quality Control (QC) laboratory including direct reports and budgetary responsibilities * Member of the Laboratory Center of Excellence (COE) * Serves as the standalone laboratory systems ...
PR · On-site
Manages the Quality Control (QC) laboratory including direct reports and budgetary responsibilities * Member of the Laboratory Center of Excellence (COE) * Serves as the standalone laboratory systems ...
Quality Assurance & cGMP Compliance * GMP Document Approval * Investigation & Root Cause Analysis ... laboratory, and Annual Product Quality Review (APQRs) elements. * Approves or rejects procedures ...
Quality Assurance & cGMP Compliance * GMP Document Approval * Investigation & Root Cause Analysis ... laboratory, and Annual Product Quality Review (APQRs) elements. * Approves or rejects procedures ...
Specialist QA
Juncos, PR · On-site
COMPETENCIES/SKILLS - Project management skills. - Strong organizational skills, including ability ... QA, QAL, validation and process development. - Demonstrate ability to interact with regulatory ...
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Specialist QA
Juncos, PR · On-site
COMPETENCIES/SKILLS - Project management skills. - Strong organizational skills, including ability ... QA, QAL, validation and process development. - Demonstrate ability to interact with regulatory ...
Specialist QA
Juncos, PR · On-site
Designee for QA manager on local CCRB. * Review Risk Assessments. * Support Automation activities. * Support facilities and environmental programs. * Review and approve Work Orders. * Review and ...
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Specialist QA
Juncos, PR · On-site
Designee for QA manager on local CCRB. * Review Risk Assessments. * Support Automation activities. * Support facilities and environmental programs. * Review and approve Work Orders. * Review and ...
Specialist QA
Juncos, PR · On-site
COMPETENCIES/SKILLS - Project management skills. - Strong organizational skills, including ability ... QA, QAL, validation and process development. - Demonstrate ability to interact with regulatory ...
Specialist QA
Juncos, PR · On-site
COMPETENCIES/SKILLS - Project management skills. - Strong organizational skills, including ability ... QA, QAL, validation and process development. - Demonstrate ability to interact with regulatory ...
$38/hr
Owning site quality program procedures and acting as designee for the QA manager * Reviewing risk assessments and supporting automation, facilities, and environmental programs * Approving work orders ...
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$38/hr
Owning site quality program procedures and acting as designee for the QA manager * Reviewing risk assessments and supporting automation, facilities, and environmental programs * Approving work orders ...
Specialist Quality Assurance
Juncos, PR · On-site
For QA Services in the Downstream area. WHAT MAKES YOU A FIT: The Technical Part: * Bachelor ... Project Management skills. * Shift: Administrative shift, and according to business needs.
Specialist Quality Assurance
Juncos, PR · On-site
For QA Services in the Downstream area. WHAT MAKES YOU A FIT: The Technical Part: * Bachelor ... Project Management skills. * Shift: Administrative shift, and according to business needs.
... and managed, and support the communities we serve. This is hard, urgent, selfless work-but it ... We are currently hiring a Technician - Quality Assurance. This role supports critical work that ...
... and managed, and support the communities we serve. This is hard, urgent, selfless work-but it ... We are currently hiring a Technician - Quality Assurance. This role supports critical work that ...
PR · On-site
$45K - $52K/yr
Follow It - case management software We serve over 150,000 customers every year. It is paramount ... We are looking for a Quality Assurance Engineer to help us validate, test, and continuously improve ...
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... and managed, and support the communities we serve. This is hard, urgent, selfless work-but it ... We are currently hiring a Technician - Quality Assurance. This role supports critical work that ...
... and managed, and support the communities we serve. This is hard, urgent, selfless work-but it ... We are currently hiring a Technician - Quality Assurance. This role supports critical work that ...
PR · On-site
The Specialist, Quality Assurance is responsible for QA batch record review and disposition ... Conform to EHS management system requirements and compliance obligations, promote continuous ...
This position reports to the Sr. Manager QA Engineering and is part of the Quality Assurance ... Partner with Manufacturing, Engineering, Laboratory, Product Engineering, and Quality teams to ...
This position reports to the Sr. Manager QA Engineering and is part of the Quality Assurance ... Partner with Manufacturing, Engineering, Laboratory, Product Engineering, and Quality teams to ...
This position reports to the Sr. Manager QA Engineering and is part of the Quality Assurance ... Partner with Manufacturing, Engineering, Laboratory, Product Engineering, and Quality teams to ...
This position reports to the Sr. Manager QA Engineering and is part of the Quality Assurance ... Partner with Manufacturing, Engineering, Laboratory, Product Engineering, and Quality teams to ...
This position reports to the Sr. Manager QA Engineering and is part of the Quality Assurance ... Partner with Manufacturing, Engineering, Laboratory, Product Engineering, and Quality teams to ...
This position reports to the Sr. Manager QA Engineering and is part of the Quality Assurance ... Partner with Manufacturing, Engineering, Laboratory, Product Engineering, and Quality teams to ...
How about this one? We're seeking an Quality Assurance Specialist to work with one of our top ... Communicates with management for Quality Initiatives, Projects, Product Transfers, etc. * Incumbent ...
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How about this one? We're seeking an Quality Assurance Specialist to work with one of our top ... Communicates with management for Quality Initiatives, Projects, Product Transfers, etc. * Incumbent ...
Quality Assurance Laboratory Manager information
What is a quality assurance laboratory manager?
Quality Assurance Laboratory Managers are professionals responsible for overseeing the operations and quality standards in laboratory environments. They ensure that all processes comply with regulatory requirements and that test results are accurate and reliable. Their duties include managing staff, developing quality control procedures, conducting audits, and troubleshooting issues within the lab. They play a critical role in maintaining the integrity of laboratory data and supporting the overall quality objectives of their organization.
What are the key skills and qualifications needed to thrive as a quality assurance laboratory manager?
To thrive as a Quality Assurance Laboratory Manager, you need a solid background in laboratory science, quality control procedures, and management, typically supported by a relevant science degree and experience in laboratory environments. Familiarity with quality management systems (such as ISO 17025), laboratory information management systems (LIMS), and regulatory compliance certifications is essential. Strong leadership, attention to detail, and effective communication are crucial soft skills for ensuring team performance and regulatory adherence. These skills and qualities are vital for maintaining high laboratory standards, ensuring product safety, and achieving organizational compliance.
What are some typical challenges a quality assurance laboratory manager may face, and how can they be addressed?
A Quality Assurance Laboratory Manager often faces challenges such as ensuring compliance with evolving regulatory standards, managing diverse teams, and maintaining the accuracy and reliability of test results under tight deadlines. Addressing these challenges involves staying up-to-date with industry regulations, fostering a culture of open communication, and implementing robust quality control protocols. Regular training sessions, cross-functional collaboration, and continuous process improvement are key strategies for overcoming these hurdles and ensuring both team effectiveness and product quality.
What are popular job titles related to Quality Assurance Laboratory Manager jobs in Puerto Rico?
For Quality Assurance Laboratory Manager jobs in Puerto Rico, the most frequently searched job titles are:
What job categories do people searching Quality Assurance Laboratory Manager jobs in Puerto Rico look for?
The top searched job categories for Quality Assurance Laboratory Manager jobs in Puerto Rico are:
What cities in Puerto Rico are hiring for Quality Assurance Laboratory Manager jobs?
Cities in Puerto Rico with the most Quality Assurance Laboratory Manager job openings:
Job description
QUALITY CONSULTING GROUP, a leader in the pharmaceutical, biotech, medical devices, and manufacturing industry, is looking for a talented, highly motivated and enthusiastic to join our team. In this role, you'll work with a highly enthusiastic team, contributing in a world-class manufacturing industry in Puerto Rico & USA.
Responsibilities:
Qualifications:
Quality Consulting Group, LLC is an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, protected veteran status, disability status, or any other characteristic protected by law.
Responsibilities:
- Review, approve, and maintain manufacturing process documentation (MPs) in compliance with cGMP requirements
- Review, approve, and ensure accuracy, completeness, and traceability of GMP documentation, including protocols, reports, investigations, and quality records
- Approve process validation protocols and reports, including PPQs and cleaning validation documentation
- Participate as Quality representative on incident triage teams, ensuring timely and compliant decision-making
- Review and approve planned incidents, deviations, and nonconformances, ensuring appropriate risk assessment and documentation
- Approve Environmental Characterization and environmental monitoring reports
- Release and maintain compliance of sanitary utility systems
- Represent Quality Assurance on New Product Introduction (NPI) teams
- Lead and document investigations, root cause analyses, and CAPA development
- Lead and support site audits, including internal, external, and regulatory inspections
- Own, maintain, and continuously improve site quality program procedures
- Serve as QA Manager designee on the local Change Control Review Board (CCRB)
- Review and approve risk assessments and mitigation strategies
- Support automation systems, including review of validation and change documentation
- Support facilities, utilities, and environmental compliance programs
Qualifications:
- Possess a BS in Science, Engineering, Physics, Biology, Chemistry or related fields.
- Experienced working in biopharmaveutical industry, quality organization supporting deviations, validation reports, qualifications, investigations.
- 5 years of experienced in a highly regulated environment.
- Experience in Quality and Compliance, experience with validation protocols and reports for clean utilities, manufacturing processes, cleaning processes, equipment, computerized systems, change control records, deviations, etc.
- Experience in biological processes
- Strong knowledge and hands-on experience with Aseptic manufacturing processes
- Change Control Experience
- Proven experience with NPI, Change Control, FATs, Validation, PPQs, and Cleaning Validation
- Manufacturing and laboratory experience required
- Demonstrated expertise in GMP documentation practices, including protocol/report review, investigations, and regulatory submissions
- Strong understanding of manufacturing, distribution, QA/QC/QAL, validation, and process development activities
- 8hrs Monday to Friday (Administrative), available nonstandard as needed.
Quality Consulting Group, LLC is an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, protected veteran status, disability status, or any other characteristic protected by law.
About Quality Consulting Group
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