This position is focused equally on Document Control Responsibilities as well as Auditing and General Quality at the facility. This position does not include laboratory or production floor inspection responsibilities.

Job Summary

The Quality Specialist role will manage document control activities. In addition, the role will also provide the support, guidance, and leadership to production sites. This includes ensuring compliance with ISO 9001 standard and company procedures, as well as tracking performance trends, implementing improvements to existing procedures, performing inspections and training. This position has no supervisory responsibilities.

Essential Job Functions

· Controls, organizes, and maintains documented information according to the Company procedures.

· Classifies and files new documents following the established process.

· Fulfills document requests from authorized users and tracks the retrieval and disposition of documents.

· Reviews and analyzes proposed changes to controlled documents, routes them for approval, and publishes though Share Point Automate in a timely manner.

· Facilitates process consistency and adherence to quality system requirements.

· Manages training records and matrices for the plants.

· Performs plant inspections and audits as needed (Company procedures, ISO 9001 requirements, and other applicable standards and regulations).

· Follows company quality and safety procedures 100%.

· Participates and contributes to the development quality initiatives.

· Supports continual improvement in the company and shares best practices across the sites.

· Participates in investigations for complaints and internal non-conformities to ensure timely 100% completion.

· Assists in writing instructions and procedures as needed.

· Assists with ensuring compliance with applicable standards and regulations (ISO 9001, etc.).

· Assists in training and certifications of plant personnel.

· Assist in the supplier management.

· Ability to travel up to 25%.

· Other duties assigned by supervisor.

Educational and Skills Requirements

· BS degree or equivalent

· Minimum two-year work experience in quality and/or document control role in fast-paced manufacturing environment

· Well organized and systematic problem solver

· Self-starter who can prioritize tasks and works with minimal to moderate supervision

· Demonstrated attention to detail

· Strong communication skills in English both verbal and written

· Ability to prioritize multiple tasks and work independently with minimum supervision as well as in a team environment with peers and across cross-functional teams.

· Computer proficient with a variety of computer software applications in word processing, spreadsheets, database, and other software utilized in operations.

· Excellent working knowledge of Office 365 applications

· Bi-lingual a plus (Spanish, Portuguese)

Physical Demands and Work Environment

· This description reflects management’s assignment of essential functions, and it does not proscribe or restrict the tasks that may be assigned as per needed basis.

· The role requires 25% travel, 25% work in the production area and the rest of the assignments are performed in an office setting with moderate noise level.

· Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.