The QA Associate II/III independently conducts quality assurance audits of production records ... SOPs, technical reports, validation documents, QA assessment, APRs, audit documents, change control ...
The QA Associate II/III independently conducts quality assurance audits of production records ... SOPs, technical reports, validation documents, QA assessment, APRs, audit documents, change control ...
This role is responsible for overseeing the QA / QC team and ensuring the organization's products ... Approve, review, and maintain accurate documentation of quality inspections, results, and ...
This role is responsible for overseeing the QA / QC team and ensuring the organization's products ... Approve, review, and maintain accurate documentation of quality inspections, results, and ...
This role is responsible for overseeing the QA / QC team and ensuring the organization's products ... Approve, review, and maintain accurate documentation of quality inspections, results, and ...
This role is responsible for overseeing the QA / QC team and ensuring the organization's products ... Approve, review, and maintain accurate documentation of quality inspections, results, and ...
This role is responsible for overseeing the QA / QC team and ensuring the organization's products ... Approve, review, and maintain accurate documentation of quality inspections, results, and ...
This role is responsible for overseeing the QA / QC team and ensuring the organization's products ... Approve, review, and maintain accurate documentation of quality inspections, results, and ...
This role is responsible for overseeing the QA / QC team and ensuring the organization's products ... Approve, review, and maintain accurate documentation of quality inspections, results, and ...
This role is responsible for overseeing the QA / QC team and ensuring the organization's products ... Approve, review, and maintain accurate documentation of quality inspections, results, and ...
This role is responsible for overseeing the QA / QC team and ensuring the organization's products ... Approve, review, and maintain accurate documentation of quality inspections, results, and ...
This role is responsible for overseeing the QA / QC team and ensuring the organization's products ... Approve, review, and maintain accurate documentation of quality inspections, results, and ...
This role is responsible for overseeing the QA / QC team and ensuring the organization's products ... Approve, review, and maintain accurate documentation of quality inspections, results, and ...
This role is responsible for overseeing the QA / QC team and ensuring the organization's products ... Approve, review, and maintain accurate documentation of quality inspections, results, and ...
Associate Quality Control What you will do Let's do this. Let's change the world. In this vital ... Generate complete, accurate, and concise laboratory documentation using electronic systems and ...
Associate Quality Control What you will do Let's do this. Let's change the world. In this vital ... Generate complete, accurate, and concise laboratory documentation using electronic systems and ...
Associate Quality Control What you will do Let's do this. Let's change the world. In this vital ... Generate complete, accurate, and concise laboratory documentation using electronic systems and ...
Associate Quality Control What you will do Let's do this. Let's change the world. In this vital ... Generate complete, accurate, and concise laboratory documentation using electronic systems and ...
The QA Associate II/III independently conducts quality assurance audits of production records ... SOPs, technical reports, validation documents, QA assessment, APRs, audit documents, change control ...
The QA Associate II/III independently conducts quality assurance audits of production records ... SOPs, technical reports, validation documents, QA assessment, APRs, audit documents, change control ...
The QA Associate II/III independently conducts quality assurance audits of production records ... SOPs, technical reports, validation documents, QA assessment, APRs, audit documents, change control ...
The QA Associate II/III independently conducts quality assurance audits of production records ... SOPs, technical reports, validation documents, QA assessment, APRs, audit documents, change control ...
... quality assurance and quality control program designed to ensure continuous production of ... Create, document and implement inspection criteria and procedures. * Provide and oversee inspection ...
... quality assurance and quality control program designed to ensure continuous production of ... Create, document and implement inspection criteria and procedures. * Provide and oversee inspection ...
... Control, and Facilities/Engineering staff regarding compliance and quality systems ... Author, review, and approve quality documents such as risk assessments, training materials ...
... Control, and Facilities/Engineering staff regarding compliance and quality systems ... Author, review, and approve quality documents such as risk assessments, training materials ...
QA Engineering Technician IV
Newport, RI · On-site
$32.25/hr
Responsibilities: * Quality Assurance support of all programs at the Depot, Hose/Tow Cable ... Specifically, experience using the NATSC Depot Application (NDA) and CMPro document control system.
QA Engineering Technician IV
Newport, RI · On-site
$32.25/hr
Responsibilities: * Quality Assurance support of all programs at the Depot, Hose/Tow Cable ... Specifically, experience using the NATSC Depot Application (NDA) and CMPro document control system.
QA Engineering Technician IV
Newport, RI · On-site
$32.25/hr
Responsibilities: * Quality Assurance support of all programs at the Depot, Hose/Tow Cable ... Specifically, experience using the NATSC Depot Application (NDA) and CMPro document control system.
QA Engineering Technician IV
Newport, RI · On-site
$32.25/hr
Responsibilities: * Quality Assurance support of all programs at the Depot, Hose/Tow Cable ... Specifically, experience using the NATSC Depot Application (NDA) and CMPro document control system.
QA Engineering Technician IV
Newport, RI · On-site
$32.25/hr
Responsibilities: * Quality Assurance support of all programs at the Depot, Hose/Tow Cable ... Specifically, experience using the NATSC Depot Application (NDA) and CMPro document control system.
QA Engineering Technician IV
Newport, RI · On-site
$32.25/hr
Responsibilities: * Quality Assurance support of all programs at the Depot, Hose/Tow Cable ... Specifically, experience using the NATSC Depot Application (NDA) and CMPro document control system.
Quality Assurance Analyst
Carolina, RI · On-site +1
$55K - $65K/yr
Document, investigate, reproduce, track, and validate software defects, enhancement requests, and ... Experience with source control concepts or tools. * Experience with API testing, integration ...
Quality Assurance Analyst
Carolina, RI · On-site +1
$55K - $65K/yr
Document, investigate, reproduce, track, and validate software defects, enhancement requests, and ... Experience with source control concepts or tools. * Experience with API testing, integration ...
Quality Engineer (Assurance)
Westerly, RI · On-site
$72K - $93K/yr
... NAVSEA quality assurance provisions throughout the product lifecycle. Key Responsibilities ... Understanding of controlled documentation and revision control practices. * Awareness of audit ...
Quality Engineer (Assurance)
Westerly, RI · On-site
$72K - $93K/yr
... NAVSEA quality assurance provisions throughout the product lifecycle. Key Responsibilities ... Understanding of controlled documentation and revision control practices. * Awareness of audit ...
Quality Engineer (Assurance)
Westerly, RI · On-site
$70 - $100/hr
... NAVSEA quality assurance provisions throughout the product lifecycle. Key Responsibilities ... Understanding of controlled documentation and revision control practices. * Awareness of audit ...
Quality Engineer (Assurance)
Westerly, RI · On-site
$70 - $100/hr
... NAVSEA quality assurance provisions throughout the product lifecycle. Key Responsibilities ... Understanding of controlled documentation and revision control practices. * Awareness of audit ...
Quality Assurance Manager
Newport, RI · On-site
$92K - $166K/yr
The Quality Assurance Manager will: * Provide Towed Array Depot Quality Assurance oversight and ... Document Management System. If you're looking for comfort, keep scrolling. At Leidos, we outthink ...
New
Quality Assurance Manager
Newport, RI · On-site
$92K - $166K/yr
The Quality Assurance Manager will: * Provide Towed Array Depot Quality Assurance oversight and ... Document Management System. If you're looking for comfort, keep scrolling. At Leidos, we outthink ...
New
Quality Assurance Document Control Associate information
What is a quality assurance document control associate?
A Quality Assurance Document Control Associate is responsible for managing, organizing, and maintaining documentation related to quality assurance processes within an organization. They ensure that all quality documents, such as standard operating procedures (SOPs), work instructions, and records, are accurate, up-to-date, and comply with regulatory requirements. Their role often involves reviewing, issuing, archiving, and tracking documents, as well as supporting audits and ensuring that employees use the correct versions of documents. This position is critical in industries like pharmaceuticals, biotechnology, and manufacturing, where document control is vital for regulatory compliance and quality management.
What are the key skills and qualifications needed to thrive as a quality assurance document control associate?
To thrive as a Quality Assurance Document Control Associate, you need strong organizational skills, attention to detail, and familiarity with regulatory requirements, often supported by a degree in life sciences or a related field. Proficiency with document management systems (DMS), electronic quality management systems (eQMS), and standards such as ISO or FDA regulations is crucial. Effective communication, time management, and the ability to work meticulously under deadlines are valuable soft skills for this role. These competencies ensure the accuracy, compliance, and efficient handling of critical documentation, which is essential for maintaining quality standards in regulated industries.
What are the main challenges quality assurance document control associates face when managing document version control in regulated industries?
Quality Assurance Document Control Associates often encounter challenges ensuring all documents are current, accurate, and accessible to authorized personnel, especially in highly regulated industries like pharmaceuticals or medical devices. Managing version control requires meticulous attention to detail to prevent outdated documents from being used in production or audits. Additionally, coordinating timely reviews and approvals from multiple stakeholders can be complex, making strong organizational and communication skills essential for success in this role.
What is the difference between Quality Assurance Document Control Associate vs Quality Assurance Specialist?
| Aspect | Quality Assurance Document Control Associate | Quality Assurance Specialist |
|---|---|---|
| Primary Role | Manage and maintain quality documentation, ensure document accuracy, control revisions | Develop, implement, and monitor quality assurance processes and procedures |
| Required Credentials | Typically a high school diploma or associate degree; familiarity with document management systems | Bachelor's degree in quality, engineering, or related field; certifications like CQE often preferred |
| Work Environment | Office setting, regulated industries like pharmaceuticals, manufacturing | Laboratory, manufacturing, or quality assurance departments in similar industries |
| Key Focus | Document control, compliance, record keeping | Process improvement, quality audits, compliance management |
While both roles support quality assurance, the Document Control Associate primarily handles documentation and record management, whereas the Quality Assurance Specialist focuses on developing and overseeing quality processes. The Associate role is more administrative, while the Specialist role involves active process improvement and compliance oversight.
What cities in Rhode Island are hiring for Quality Assurance Document Control Associate jobs?
Cities in Rhode Island with the most Quality Assurance Document Control Associate job openings:
Quality Assurance Associate I
Cumberland, RI • On-site
CEDENT •
IT Services • 11 - 50 employees11 - 50 employees
Full-time
Re-posted 8 days ago
Job description
SUMMARY/OBJECTIVE
This position supports activities of the Quality Assurance Department regarding pharmaceutical manufacturing, testing and packaging to ensure compliance with all relevant pharmaceutical regulatory requirements: FDA, GMP. Provides QA oversight to operations under direction of the QA Manager. Provides review, impact/risk assessment analysis, detailed improvement plans for change controls, deviations, investigations and CAPA. Adheres to Client compliance initiatives, including
following all quality and division/company policy requirements. Helps to ensure that all Client products meet quality requirements by supporting all assigned quality aspects of product approval. The QA Associate II/III independently conducts quality assurance audits of production records (manufacturing, analytical and quality control records) and facility records assuring company standards are maintained and product integrity is preserved.
RESPONSIBILITIES
1. Provide support to GMP investigations, validation documentation review and approval, identify gaps within existing Quality Systems and propose solutions for functional management;
2. Participates/leads internal/external audits, prepare and issue audit reports. Recommend remediation actions and follow up on implementation of the plan.
3. Supports resolution of technical and compliance issues/gap analysis.
4. Aides implementation of Quality Systems/System Improvements.
5. Supports and assists with Quality systems-related training, including compliance with cGMP and SOPs.
6. Interface with key quality, manufacturing, customers and coordinate documentation impacting quality areas.
7. Review/approval of all cGMP documents generated across site to include (but not limited to): SOPs, technical reports, validation documents, QA assessment, APRs, audit documents, change control, deviation & document revisions, etc.
8. Participates in activities associated with primary batch record review, non-conformances investigation and CAPA.
9. Work in coordination with regulatory affairs group in support of ANDA submissions.
10. Provides QA review/approval of all cGMP documents associated with manufacture of product.
11. Communicates with contractors and internal manufacturing/technical groups regarding compliance and quality issues (i.e., batch documentation, investigations, timelines and data related issues).
12. Authors or revises SOPs as necessary.
13. Actively engaged in the training of staff with lesser experience or knowledge of quality assurance processes. Educate and instruct QA and plant personnel in quality best practices for sampling, labeling,
good documentation practices, equipment sanitation. Confirm these procedures are being adhered to, taking corrective actions when non-conformances are observed.
14. Routinely provide input to quality and operations management for better operational procedures to improve overall efficiency and regulatory compliance.
15. Assist in development of special department projects and work in conjunction with quality management.
16. Other duties as assigned.
COMPETENCIES
1. Project Management
2. Technical Capacity.
3. Discretion.
4. Problem Solving/Analysis.
5. Decision Making.
6. Communication Proficiency.
7. Collaboration Skills.
8. Learning Agility
9. Managing Changing Priorities
POSITION TYPE/EXPECTED HOURS OF WORK
This is a full-time position requiring 40 or more hours of work per week.
This position supports activities of the Quality Assurance Department regarding pharmaceutical manufacturing, testing and packaging to ensure compliance with all relevant pharmaceutical regulatory requirements: FDA, GMP. Provides QA oversight to operations under direction of the QA Manager. Provides review, impact/risk assessment analysis, detailed improvement plans for change controls, deviations, investigations and CAPA. Adheres to Client compliance initiatives, including
following all quality and division/company policy requirements. Helps to ensure that all Client products meet quality requirements by supporting all assigned quality aspects of product approval. The QA Associate II/III independently conducts quality assurance audits of production records (manufacturing, analytical and quality control records) and facility records assuring company standards are maintained and product integrity is preserved.
RESPONSIBILITIES
1. Provide support to GMP investigations, validation documentation review and approval, identify gaps within existing Quality Systems and propose solutions for functional management;
2. Participates/leads internal/external audits, prepare and issue audit reports. Recommend remediation actions and follow up on implementation of the plan.
3. Supports resolution of technical and compliance issues/gap analysis.
4. Aides implementation of Quality Systems/System Improvements.
5. Supports and assists with Quality systems-related training, including compliance with cGMP and SOPs.
6. Interface with key quality, manufacturing, customers and coordinate documentation impacting quality areas.
7. Review/approval of all cGMP documents generated across site to include (but not limited to): SOPs, technical reports, validation documents, QA assessment, APRs, audit documents, change control, deviation & document revisions, etc.
8. Participates in activities associated with primary batch record review, non-conformances investigation and CAPA.
9. Work in coordination with regulatory affairs group in support of ANDA submissions.
10. Provides QA review/approval of all cGMP documents associated with manufacture of product.
11. Communicates with contractors and internal manufacturing/technical groups regarding compliance and quality issues (i.e., batch documentation, investigations, timelines and data related issues).
12. Authors or revises SOPs as necessary.
13. Actively engaged in the training of staff with lesser experience or knowledge of quality assurance processes. Educate and instruct QA and plant personnel in quality best practices for sampling, labeling,
good documentation practices, equipment sanitation. Confirm these procedures are being adhered to, taking corrective actions when non-conformances are observed.
14. Routinely provide input to quality and operations management for better operational procedures to improve overall efficiency and regulatory compliance.
15. Assist in development of special department projects and work in conjunction with quality management.
16. Other duties as assigned.
COMPETENCIES
1. Project Management
2. Technical Capacity.
3. Discretion.
4. Problem Solving/Analysis.
5. Decision Making.
6. Communication Proficiency.
7. Collaboration Skills.
8. Learning Agility
9. Managing Changing Priorities
POSITION TYPE/EXPECTED HOURS OF WORK
This is a full-time position requiring 40 or more hours of work per week.
About Cedent
Sourced by ZipRecruiter
CEDENT strives to attract and retain the best people and provide an environment where they can all develop professionally and build a rewarding career. As a result, we create an inclusive environment that is rich in diversity, acknowledges each individual's uniqueness and promotes respect, personal achievement and stewardship. Our clients are global and so is CEDENT. We build and maintain a global workforce that includes people from different backgrounds, with a vast range of skills and experience all united by a common culture and commitment to help our clients achieve high performance. Cultivating a diverse workforce and inclusive work environment makes business sense. Our peoples varied skills are the talent engine that powers CEDENT, enabling it in turn to deliver the innovative solutions that help our clients outperform competitors.
Industry
It services
Company size
11 - 50 Employees
Headquarters location
Plano, TX, US
Year founded
2008