Quality Assurance Associate

Quality Assurance Associate Document Control Training and Asset Management

Job Purpose

The Quality Assurance Associate supports the effective operation of the Quality Management System through accurate and timely administration of document control training equipment calibration/preventive maintenance and related quality records. The position is responsible for executing established quality system processes maintaining required logs and records monitoring routine due dates and escalating issues in accordance with approved procedures.

The QA Associate works collaboratively with the QA Specialist and Sr. Quality Systems Engineer. The roles are expected to coordinate closely and provide cross-training and backup support for assigned processes; however the QA Associate does not report to the QA Specialist. The position operates under departmental management and escalates quality decisions requiring independent technical or compliance judgment.

Document Control & Records Administration

• Administer day-to-day document control activities including processing document change requests routing documents for review and approval issuing effective documents maintaining controlled copies and archiving superseded records in accordance with approved procedures.
• Perform document quality control checks for formatting required approvals metadata references and completeness; promptly communicate irregularities and coordinate correction prior to release.
• Maintain controlled Quality System documents and records including SOPs Work Instructions forms specifications drawings batch records protocols reports and other applicable technical documentation.
• Support authors and process owners with document templates document numbering routing requirements and document control procedures.
• Maintain external standards and regulatory reference records applicable to manufacturing quality and design activities.
• Support document migration and data verification activities associated with implementation and maintenance of the electronic Quality Management System (eQMS).

Training Administration

• Administer the training system including assignment of required training maintenance of training curricula and records tracking of completion and follow-up on overdue training.
• Coordinate training assignments resulting from new or revised controlled documents and verify completion before or following document effective dates as required by procedure.
• Support preparation of training status reports and escalate overdue or incomplete training to responsible managers and Quality management.
• Provide routine user support for the training system and assist with eQMS training administration.

Asset Management Calibration & Preventive Maintenance

• Administer the equipment calibration and preventive maintenance program including maintenance of the asset database scheduling due-date tracking and coordination with internal personnel and outside service providers.
• Collect and maintain calibration preventive maintenance qualification and service records and perform defined administrative/documentation checks for completeness.
• Monitor upcoming and overdue calibration and preventive maintenance activities and escalate overdue missing or potentially non-conforming equipment records to the QA Specialist Sr. Quality Systems Engineer or Quality management as appropriate.
• Support equipment status labeling and other routine asset-control activities in accordance with approved procedures.

Quality System Support

• Maintain quality system logs and trackers and support collection of data used for quality metrics and Management Review.
• Provide administrative support for NCMR deviation CAPA complaint audit and other quality system records including record initiation routing tracking filing and follow-up as assigned.
• Support batch release activities through record compilation document verification and other assigned activities performed in accordance with approved procedures and authorization levels.
• Retrieve records and documentation in support of internal external customer Notified Body and FDA audits or inspections.
• Support implementation migration testing and ongoing administration of eQMS workflows in coordination with the QA Specialist and Sr. Quality Systems Engineer.
• Identify recurring administrative issues or opportunities for process improvement and communicate them to process owners and Quality management.
• Provide backup support for defined QA Specialist activities when trained and authorized.
• Perform other duties and quality projects as assigned.

Skills / Qualifications

• Bachelors degree in a scientific technical business or related discipline preferred; relevant education and experience may be accepted in lieu of a degree.
• 02 years of experience in Quality Assurance document control regulated manufacturing or a related function preferred. Medical device or pharmaceutical experience is desirable.
• Basic knowledge of or ability to learn ISO 13485 and 21 CFR Part 820 (Quality Management System Regulation/QMSR). Exposure to 21 CFR Parts 210/211 and Part 4 for combination products is desirable.
• Strong attention to detail and demonstrated ability to maintain accurate records manage multiple due dates and follow established procedures.
• Strong written and verbal communication skills and ability to coordinate effectively with employees at all organizational levels.
• Proficiency with Microsoft Word Excel PowerPoint and electronic document or quality management systems; eQMS experience preferred.
• Ability to recognize and escalate discrepancies overdue activities or situations requiring Quality review.
• Positive collaborative and dependable working style with willingness to cross-train and provide backup support across Quality Assurance activities.

Required Experience:

IC