Title:  Quality Associate

Job Summary

Essential Duties and Responsibilities

• Provide guidance on documentation structures and format to ensure compliance to procedures, relevant regulations and standards
• Manage and maintain traceable, accountable, password protected, documentation system in compliance with Corporate guidelines.
• Inspects in-process production by confirming specifications, conducting Visual, Dimensional and Functional tests, and communicating required adjustments to required personnel. May lead the process for raw materials acceptance activities including issuance of Certificate of Compliance.
• Support batch release by completing batch card review and provide quality document control oversight on documentation and reports
• Approve batch records against approved specifications, quality standards, company procedures and regulatory filings for release of product to market
• Collaborate with teams on the development of product development DHF documents, specifically in regard to facilitating document control activities
• Contribute to and support the development of product development QMS procedures and work instructions
• Calibrates all equipment gauges, measuring devices, weighing devices and hand-held gauging devices.
• Identify, define, monitor, track, and report on documentation metrics (e.g., documentation release rates, documentation rejection rates, etc.)
• Responsible for identification, front line management and appropriate escalation of major and critical incidents.
• Generate associated OOS/Deviation/Non-Conformances
• Work collaboratively with internal customers to refine and optimize analysis and reporting criteria as well as manage expectations around analysis delivery timelines and output capabilities
• Leading the process of the approval of all graphic and label related raw material.
• Establish routine communication strategies for project tracking and prioritization
• Drive continuous quality improvement efforts to reduce scrap, cycle times, improve efficiency, and eliminate waste.
• Responsible for conducting Production floor GEMBA walks
• Compliance to all Environmental, Health and Safety regulations.
• Compliance to all company policies, procedures, and corporate policies.

Additional Responsibilities

Education

• Bachelor's Degree Vocational, technical training or degree with emphasis in Quality Control preferred

Work Experience

• Minimum 3 years of experience in regulated Quality Assurance / Quality Control required
• Minimum 3 years of experience in medical devices or pharmacy industry preferred

Preferred Knowledge, Skills and Abilities

• Ability to work independently, multi-task and thrive in fast-paced environment
• Experience with managing Document Control activities within a regulated industry
• Excellent written and verbal communication skills
• Proficient in Windows OS, Microsoft Office Suite including Word, Excel, and Power Point
• Familiarity with Master Control, SAP/ERP system and SharePoint
• Must have effective problem solving and interpersonal skills

License and Certifications

Travel Requirements

Physical Requirements

Additional Requirements

• Adaptable to changes in the work environment, manage competing demands and deal with frequent change, delays or unexpected events
• Must maintain the ability to work well with others in a variety of situations
• Specific vision abilities required by this job include close vision, distance vision, color vision, depth perception and the ability to adjust focus.
• Ability to perform basic mathematical tasks like counting, adding, subtracting, and rounding and to record, balance and check for accuracy.
• Effectively communicate and interface with various levels internally and with customers