Top 6 Quality assurance associate Jobs in Coventry, Ri

Quality Assurance Associate I
CEDENT —Cumberland, RI
- Full-time
- Mid-level
- Communication skills
Senior Associate Manufacturing Deviation Owner Environmental and Contamination Control
Amgen —West Greenwich, RI
- $86,048.05 - $116,417.95 a year
- Bachelor of Science
- Master's degree
- High school diploma or GED
- Disability insurance
- Health insurance
Quality Associate
Composite Energy Technologies —Bristol, RI
- Full-time
- Microsoft Word
- Microsoft Excel
- Microsoft Outlook
- Health insurance
- Dental insurance
Quick Apply

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Quality Assurance Associate I

CEDENT -
Cumberland, RI

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Job Details

Full-time

Qualifications

FDA submissions
Investigations regulatory compliance
Quality records maintenance
Audit report preparation
Laboratory document review
Document control experience within pharmaceutical industry
Labeling
Preventive action implementation
Production deviation management
Compliance audits & assessments
Gap analysis
Quality control preventive actions
Corrective and preventive actions (CAPA)
Mid-level
Technical report writing
Improving operational efficiency
Internal investigations
Quality control audit
Quality reports
Manufacturing standard operating procedures
Quality risk management
Task prioritization
Decision making
System validation
Quality assurance experience within pharmaceutical industry
Quality improvement
Compliance documentation
Internal compliance assessments
Regulatory/legal compliance standards in production
Collaboration with manufacturing teams

Full 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.

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quality assurance associate jobs in coventry, ri

Quality Assurance Associate I

Senior Associate Manufacturing Deviation Owner Environmental and Contamination Control

Quality Associate

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