Manages audit observation, investigations, change control, and CAPAs records in the applicable QMS on timely manner. * Provides technical guidance and quality assurance support in the transfer of new ...
Manages audit observation, investigations, change control, and CAPAs records in the applicable QMS on timely manner. * Provides technical guidance and quality assurance support in the transfer of new ...
Manager, Quality Assurance Scientist (will not be supervising) Hybrid/OnSite: 100% On SIte PRINCIPAL OBJECTIVE OF POSITION: Accountable for assuring that the manufacturing and/or support areas ...
Manager, Quality Assurance Scientist (will not be supervising) Hybrid/OnSite: 100% On SIte PRINCIPAL OBJECTIVE OF POSITION: Accountable for assuring that the manufacturing and/or support areas ...
PR · On-site
Manager, Quality Assurance Scientist (will not be supervising) Hybrid/OnSite: 100% On SIte PRINCIPAL OBJECTIVE OF POSITION: Accountable for assuring that the manufacturing and/or support areas ...
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PR · On-site
Manager, Quality Assurance Scientist (will not be supervising) Hybrid/OnSite: 100% On SIte PRINCIPAL OBJECTIVE OF POSITION: Accountable for assuring that the manufacturing and/or support areas ...
The Senior Manager partners cross-functionally with Quality Assurance, Quality Control, Manufacturing, Engineering, Supply Chain, Regulatory Affairs and Compliance, Process Development, Environmental ...
The Senior Manager partners cross-functionally with Quality Assurance, Quality Control, Manufacturing, Engineering, Supply Chain, Regulatory Affairs and Compliance, Process Development, Environmental ...
The Senior Manager partners cross-functionally with Quality Assurance, Quality Control, Manufacturing, Engineering, Supply Chain, Regulatory Affairs and Compliance, Process Development, Environmental ...
The Senior Manager partners cross-functionally with Quality Assurance, Quality Control, Manufacturing, Engineering, Supply Chain, Regulatory Affairs and Compliance, Process Development, Environmental ...
PR · On-site
As the Quality Assurance Specialist, you will play a vital role in the PharmaLogic quality program ... Notify facility manager if any recall necessary to assure that recalled materials are not ...
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PR · On-site
As the Quality Assurance Specialist, you will play a vital role in the PharmaLogic quality program ... Notify facility manager if any recall necessary to assure that recalled materials are not ...
Specialist QA
Juncos, PR · On-site
Alert senior management of quality, compliance, supply, and safety risks. * Support GMP building ... Strong knowledge of QA, QAL, validation, process development, and GMP manufacturing. * Advanced ...
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Specialist QA
Juncos, PR · On-site
Alert senior management of quality, compliance, supply, and safety risks. * Support GMP building ... Strong knowledge of QA, QAL, validation, process development, and GMP manufacturing. * Advanced ...
$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 QA - 35615
Juncos, PR · On-site
... project management involved. Position Summary The Specialist QA is responsible for ensuring ... compliance with quality standards, regulatory requirements, and internal procedures throughout ...
Specialist QA - 35615
Juncos, PR · On-site
... project management involved. Position Summary The Specialist QA is responsible for ensuring ... compliance with quality standards, regulatory requirements, and internal procedures throughout ...
... project management involved. Position Summary The Specialist QA is responsible for ensuring ... compliance with quality standards, regulatory requirements, and internal procedures throughout ...
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... project management involved. Position Summary The Specialist QA is responsible for ensuring ... compliance with quality standards, regulatory requirements, and internal procedures throughout ...
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.
This position reports to the Sr. Manager QA Engineering and is part of the Quality Assurance Engineering Team located in Fajardo, Puerto Rico and will be an on-site role. What you will do: * Provide ...
This position reports to the Sr. Manager QA Engineering and is part of the Quality Assurance Engineering Team located in Fajardo, Puerto Rico and will be an on-site role. What you will do: * Provide ...
Communicates with management for Quality Initiatives, Projects, Product Transfers, etc. * Incumbent ... , R&D in pharmaceutical, biologics, device or chemical industry * Must be familiar with use of ...
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Communicates with management for Quality Initiatives, Projects, Product Transfers, etc. * Incumbent ... , R&D in pharmaceutical, biologics, device or chemical industry * Must be familiar with use of ...
This position reports to the Sr. Manager QA Engineering and is part of the Quality Assurance Engineering Team located in Fajardo, Puerto Rico and will be an on-site role. What you will do: Provide ...
This position reports to the Sr. Manager QA Engineering and is part of the Quality Assurance Engineering Team located in Fajardo, Puerto Rico and will be an on-site role. What you will do: Provide ...
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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This position reports to the Sr. Manager QA Engineering and is part of the Quality Assurance Engineering Team located in Fajardo, Puerto Rico and will be an on-site role. What you will do: * Provide ...
This position reports to the Sr. Manager QA Engineering and is part of the Quality Assurance Engineering Team located in Fajardo, Puerto Rico and will be an on-site role. What you will do: * Provide ...
This position reports to the Sr. Manager QA Engineering and is part of the Quality Assurance Engineering Team located in Fajardo, Puerto Rico and will be an on-site role. What you will do: * Provide ...
This position reports to the Sr. Manager QA Engineering and is part of the Quality Assurance Engineering Team located in Fajardo, Puerto Rico and will be an on-site role. What you will do: * Provide ...
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 Engineering Team located in Fajardo, Puerto Rico and will be an on-site role. What you will do: * Provide ...
This position reports to the Sr. Manager QA Engineering and is part of the Quality Assurance Engineering Team located in Fajardo, Puerto Rico and will be an on-site role. What you will do: * Provide ...
QA Specialist-35615
Juncos, PR · On-site
Serve as the QA Manager's designee on the local Change Control Review Board (CCRB). * Review and approve Risk Assessments. * Support automation-related quality activities. * Provide quality support ...
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QA Specialist-35615
Juncos, PR · On-site
Serve as the QA Manager's designee on the local Change Control Review Board (CCRB). * Review and approve Risk Assessments. * Support automation-related quality activities. * Provide quality support ...
Manager Quality Assurance information
What does a manager of quality assurance do?
A manager of quality assurance oversees the development and implementation of quality standards and procedures to ensure products or services meet company and industry requirements. They lead quality teams, analyze data to identify issues, and coordinate testing and inspection processes, often using tools like quality management systems. Strong leadership, communication, and knowledge of industry regulations are essential for this role.
What are the key skills and qualifications needed to thrive as a Manager Quality Assurance?
To thrive as a Manager Quality Assurance, you need a solid background in quality management systems, process improvement, and industry-specific regulations, often supported by a relevant degree and experience in quality roles. Familiarity with tools like Six Sigma, ISO standards, statistical analysis software, and quality audit systems is typically required. Strong leadership, problem-solving, and communication skills help drive continuous improvement and foster a culture of quality within teams. These competencies are crucial for ensuring product or service excellence, regulatory compliance, and operational efficiency.
What are some common challenges faced by a Manager Quality Assurance, and how can they be addressed?
A Manager Quality Assurance often faces challenges such as aligning quality standards across departments, managing tight deadlines, and ensuring regulatory compliance. To address these, it's important to foster clear communication between teams, establish robust quality management systems, and provide ongoing training. Proactively identifying potential issues and encouraging a culture of continuous improvement can also help minimize defects and boost overall team performance.
What are the roles and responsibilities of a Manager Quality Assurance?
A Manager of Quality Assurance oversees the quality control processes within an organization to ensure that products or services meet established standards and customer expectations. They develop and implement quality management systems, lead quality audits, and supervise QA teams. Additionally, they analyze data to identify trends or areas for improvement, work with other departments to resolve quality issues, and ensure compliance with industry regulations and certifications.
Is a quality assurance manager a stressful job?
A quality assurance manager often faces stress related to meeting strict quality standards, tight deadlines, and managing team performance. The role requires attention to detail, problem-solving skills, and sometimes long hours during product launches or audits, which can contribute to job-related stress.
What do quality assurance managers do?
Quality assurance managers oversee the testing and inspection of products or services to ensure they meet quality standards and customer expectations. They develop quality control procedures, analyze data to identify issues, and coordinate with teams to implement improvements, often using tools like quality management systems and industry certifications. Their role involves continuous monitoring and reporting to maintain product consistency and compliance.
What are the most commonly searched types of Quality Assurance jobs in Puerto Rico? The most popular types of Quality Assurance jobs in Puerto Rico are:
What are popular job titles related to Manager Quality Assurance jobs in Puerto Rico? For Manager Quality Assurance jobs in Puerto Rico, the most frequently searched job titles are:
What job categories do people searching Manager Quality Assurance jobs in Puerto Rico look for? The top searched job categories for Manager Quality Assurance jobs in Puerto Rico are:
What cities in Puerto Rico are hiring for Manager Quality Assurance jobs? Cities in Puerto Rico with the most Manager Quality Assurance job openings:
Contractor
Posted 9 days ago
Job description
For Compliance services in the Quality area.
WHAT MAKES YOU A FIT:
The Technical Part:
The Personality Part:
AS A PIECE OF FITS, YOU WILL: (The day-to-day on the job)
WHO WE ARE:
We are a Service Provider company different from the rest. We pride ourselves on how we treat the most important piece of our company's puzzle: you! We integrate Engineering, Construction, Maintenance, Utilities, and Specialized Technical services across the Island (and in the US as well!). Our company is flexible, family-oriented, and focused on our resources' well-being, while providing our Pharmaceutical, Medical Device, and Manufacturing industry clients with top-notch quality talent. We're FITS!
Are you the Next Piece?
WHAT MAKES YOU A FIT:
The Technical Part:
- Bachelor's Degree in Chemical Engineering, Biology, or Microbiology Science & six (6) years of experience in the Pharmaceutical Manufacturing industry.
- Bilingual (English & Spanish)
- Shifts: Administrative, and according to business needs.
- Experience in:
- Quality Assurance & cGMP Compliance
- GMP Document Approval
- Investigation & Root Cause Analysis
- Cross-Functional Collaboration
The Personality Part:
- Our Next Piece is someone who treats everyone they meet like family, especially our resources, clients, and team members. In other words, being a customer service pro is one of your (many) talents. Being the Piece means you're full of bright ideas and eager to innovate, consistently delivering top-quality results. Are you ready to Be The Piece?
AS A PIECE OF FITS, YOU WILL: (The day-to-day on the job)
- Interfaces directly with manufacturing and/or support areas operations to ensure that appropriate procedures are in place, through the execution of thorough reviews of procedures against practice.
- Leads and participates in the critical review of all documents associated with the manufacturing and/or support areas operations, release, packaging, and relevant activities in the operations areas.
- Ensures that deviations in documentation related to OOS or process parameters outside filing or validation are investigated and resolved by thoroughly reviewing timely corrective actions.
- Provides key technical guidance and oversight to manufacturing and/or support area operations (Sterile, Non-Sterile, QC Laboratories, Warehouse, Engineering, Supply Chain, MS&T, IM, among others) to ensure appropriate cGMPs are in place through quarterly, monthly, weekly, or daily operations audits, as applicable.
- Ensures compliance with all procedures (SOP's) to avoid potential regulatory and compliance issues, including GDP and electronic systems compliance.
- Provides scientific input into investigation management to ensure root causes and CAPAs are aligned with the opportunities identified, enabling a systematic approach.
- Supports actively the investigation processes in manufacturing areas (Sterile and Non Sterile) and support areas such as Warehouse, QC laboratories, IT, MS&T, facilities, and utilities, providing coaching from a quality perspective.
- Provides guidance on gaps identified from the review and actively participates in determining potential remediation activities.
- Supports risk analysis process when required per procedures.
- Evaluates product impact and provides lot disposition recommendations when an investigation is completed as needed.
- Manages audit observation, investigations, change control, and CAPAs records in the applicable QMS on timely manner.
- Provides technical guidance and quality assurance support in the transfer of new products and processes to maintain quality standards.
- Participates in Manufacturing Alignment Teams (MAT) and Project Alignment Teams (PAT), department staff, planning, and change control board meetings, as required.
- Evaluates documentation compliance, including data GDP compliance and electronic system data compliance, and its overall management requirements for all manufacturing and support areas, including QC laboratories, such as CR's, SOP's, BR's, Forms, Logbooks, BOM's, WPP's, qualification and validation Protocols, according to government regulations and clients Policies.
- Provides support to the area QA Leader during the budget preparation activities.
- Evaluates department performance indicators and develops the appropriate corrective actions if needed
- Assists management during internal and regulatory agencies inspections (FDA, DEA, MCA, etc).
- Develops sampling plans based on acceptance quality level criteria when additional or special testing is required.
- Performs trend analysis to provide recommendations in order to improve the process and /or the product quality.
- Supports Media Fill activities to ensure that both typical and atypical interventions are performed as established.
- Supports the Annual Product Review elements for Quality events of manufacturing and environmental monitoring.
- Evaluates and approves the instrumentation and equipment calibration records and critical area engineering drawings.
- Reviews and approves equipment, utilities, and facilities qualification, and system life-cycle documentation.
- Reviews and approves all process, product, and computer systems validation protocols and reports, change control documentation, redressing/reprocessing / rework operations, investigation reports related to manufacturing process and microbiology laboratory, and Annual Product Quality Review (APQRs) elements.
- Approves or rejects procedures impacting drug products, raw material, or packaging components.
- Verifies compliance with clients' policies and Guidelines.
- Participates as quality representative or liaison in site projects
- Performs pre-operational review form approval in the manufacturing and packaging area.
- Performs shop floor walk-through audits and challenges adherence to area procedures, providing coaching and Quality Support in alignment with the business unit to optimize compliance and effectiveness.
- Verifies consistency with other site procedures and/or specifications.
- Reviews and approves investigations related to process, products, utilities, microbiology laboratory, and calibrations.
- Approves Corrective and Preventive actions (CAPAs).
- Approves or rejects specifications impacting drug products, raw material, or packaging components.
- Ensures effective systems for equipment maintenance and calibration, and approves calibration requests.
- Ensures the designation and monitoring of storage conditions for quarantine materials and products.
- Reviews and approves procedures for processes, products, utilities, and laboratories.
- Maintains management informed (via frequent written reports) of any problem that might affect the quality and/or timely release of materials
WHO WE ARE:
We are a Service Provider company different from the rest. We pride ourselves on how we treat the most important piece of our company's puzzle: you! We integrate Engineering, Construction, Maintenance, Utilities, and Specialized Technical services across the Island (and in the US as well!). Our company is flexible, family-oriented, and focused on our resources' well-being, while providing our Pharmaceutical, Medical Device, and Manufacturing industry clients with top-notch quality talent. We're FITS!
Are you the Next Piece?