Administrative Skills, Meeting Minutes, Quality Management, Document Control, Quality Control, ISO 9001, ISO 14001, Continuous Improvement, Cross-Functional, Customer Support/Service, Document Management, Documentation, Process Improvement, Quality Assurance, Quality Metrics, Regulations, Regulatory Compliance, Regulatory Requirements, Safety/Work Safety, Source Code/Configuration Management (SCM),
- High School Graduate or GED required. Associates (2 year college or technical school) or Bachelor’s Degree (4 year college or technical school) preferred in a related field, or relevant experience in document control / auditing.
- 1-3 years experience in document control specialization including experience with internal and external audits. Experience working with MasterControl a plus.
- Proficiency in Microsoft Office Suite and using document control based systems.
- Experience in schedule coordination. Knowledge of ISO and RBA a plus.
- Coordinate and facilitate ISO9001, ISO14001, and customer audits. Coordinate scheduling with internal/external groups, complete pre-audit requirements with stakeholders, facilitate audits, and provide additional support for internal groups during the audit process. Own closing the audit including communicating results to stakeholders, ensuring findings are suitably completed, and preparing the final report.
- Manage document control processes, including creation, review, approval, distribution, revision, retention, and archiving quality documents, courses/curriculum and records. Responsible for the initiation of training for new and revised documents and then distributing / maintaining the department reference binders for master policies, procedures, and forms where applicable.
- Serve as the subject matter expert for internal document management system (Master Control) and provide support and training for the company including use of best practices within the system.
- Facilitate weekly cross-functional meetings to align Change Controls and CAPAs, ensuring deadlines are met and interdepartmental awareness is maintained.
- Proactively monitor and apply updated auditing standards, regulations, and internal policies to guarantee precise, compliant audits. Coordinate periodic review of procedures and forms. Maintain the archives and historical files for mastered documents and records.
- Support the maintenance of training database, training records, historical files on training programs and signature files.
- Perform new user set up in the data management system and train new hires on effective system use.
- Ensure that proper procedures are being followed in making database changes, additions and deletions.
- Complete other job-related tasks as assigned.
Paid Time-Off, Gym Membership, Life Insurance, Tuition Reimbursement, 401K, Prescription Drug Coverage, 401K Match, Paid Sick Days, Parking, Professional Development, Flexible Spending Accounts, Medical, Dental, Vision
The Quality Assurance Specialist is responsible for ensuring that products, services, processes, and quality records meet established quality standards, regulatory requirements, and customer expectations. This role develops and implements quality control and document control procedures, coordinates and facilitates audits, and collaborates with cross-functional teams to drive continuous improvement. The QA Specialist maintains the integrity of quality documentation, ensures accurate document version control and record retention, and supports compliance with customer requirements and industry regulations to maintain high levels of quality, safety, and operational excellence.