Quality Assurance Coordinator
2 weeks ago
QUALITY ASSURANCE COORDINATOR - Sample Room
A Vital Role in the Quality Assurance Division
SUMMARY: The Quality Assurance Coordinator is responsible for managing all Standard Operating Procedures (SOPs) for the manufacturing site. Key duties include updating the internal documentation site, overseeing the SOP training database, and conducting Annual Product Reviews for pharmaceutical and cosmetic items. This role also entails maintaining and evaluating quality data for reporting, performing failure analysis, and promptly addressing customer inquiries.
Key Responsibilities:
- Ensure adherence to Good Manufacturing Practices (GMPs) by accurately processing all SOPs
- Manage the SOP and GMP training database for the facility
- Identify and report training requirements to management
- Deliver necessary training as needed
- Compile and oversee Annual Product Review data, coordinating investigations for customer inquiries
- Support Quality Metrics, General Quality reporting, Audit Support, and Master Data activities
- Assist in special projects for Quality Assurance leadership
- Conduct mock recalls, participate in audits, and perform other assigned responsibilities
Experience: A minimum of 2 years of experience in a cGMP regulated environment is preferred. Proficiency in Microsoft Office applications and ERP systems is essential.
Skills:
- Exhibit teamwork, professionalism, energy, and initiative
- Comply with safety regulations and promptly report any issues
Physical Demands: The position involves various physical activities, including walking, talking, climbing, and lifting. Clear vision, color differentiation, and the ability to adjust focus are essential.
Knowledge Base: Basic literacy in reading, writing, and mathematics is required.
Licenses/Certifications: Not applicable
Equipment Utilization: Utilize standard office equipment and production tools.
Work Environment: A balance between office and production settings, with exposure to noise and physical conditions.
QUALITY ASSURANCE COORDINATOR - Sample Room
A Vital Role in the Quality Assurance Division
JOB REQUIREMENTS
EDUCATION: High school diploma or equivalent.
EXPERIENCE: A Bachelor's degree in a related field is preferred. Proficiency in Microsoft Office products and experience with computer software applications.
SPECIAL KNOWLEDGE: Working proficiency in Microsoft Word, Excel, Access, and SAP, along with technical writing and data analysis skills.
TECHNICAL SKILLS: Proficient in computer usage, technical writing, data analysis, and problem-solving.
NON-TECHNICAL SKILLS: Strong writing and organizational capabilities.
PHYSICAL REQUIREMENTS: Essential activities include standing, walking, sitting, lifting, and effective communication.
ESSENTIAL JOB FUNCTIONS
- Prepare samples for presentations with meticulous attention to detail
- Coordinate supplies and maintain organization within the sample room
- Inspect incoming shipments for quality assurance
- Ensure compliance with shipping standards
- Maintain and update inventory records
- Support the Quality Assurance Director with assigned projects
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