POSITION SUMMARY
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.
ESSENTIAL FUNCTIONS
- 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.
POSITION QUALIFICATIONS
Competency Statement(s)
Oral Communication
Ability to communicate effectively with others using the spoken word.
Written Communication
Ability to clearly and concisely communicate using the written word.
Detail Oriented
Ability to pay attention to the minute details of a project or task.
Initiative
Ability to make decisions or take actions to solve a problem or reach a goal.
Motivation
Ability to inspire oneself and others to reach a goal and perform to the best of their ability.
Problem Solving
Ability to find a solution for or deal proactively with work-related problems.
Strategic Planning
Ability to develop a vision for future and create a culture in which the long-range goals can be achieved.
Training Time Management
Ability to teach, coach, and develop specific skills in others so they can meet established work performance standards. Ability to effectively manage time with fluctuating priorities and deadlines.
Intrapersonal Skills
Ability to work effectively with all levels of people.
Organized
Possessing the trait of being organized or following a systematic method of performing a task.
SKILLS & ABILITIES
Education
High School Graduate or GED required. Bachelor’s Degree (4 year college or technical school) preferred in a related field, or relevant experience in document control / auditing.
Experience
1-3 years experience in Quality Assurance Specialist and document control including experience with internal and external audits. Experience working with MasterControl a plus.
Computer Skills
Proficiency in Microsoft Office Suite and using document control based systems.
Certifications & Licenses
Other Requirements
Experience in schedule coordination. Knowledge of ISO and RBA a plus.
PHYSICAL DEMANDS
N (Not Applicable)
Activity is not applicable to this position.
O (Occasionally)
Position requires this activity up to 33% of the time (0 – 2.5+ hrs/day)
F (Frequently)
Position requires this activity from 33% – 66% of the time (2.5 – 5.5+ hrs/day)
C (Constantly)
Position requires this activity more than 66% of the time (5.5+ hrs/day)
Frequently: Sit, manually manipulate, reach outward, grasp items, speak.
Occasionally: Stand, walk, reach above shoulders, squat or kneel. Occasionally will lift/carry up to 20 pounds and push/pull up to 100 pounds (with assist or equipment for weights greater than 50 pounds).
Not Applicable: This position does not lift or carry more than 20 pounds.
Other Physical Requirements: Ability to wear Personal Protective Equipment (PPE) including but not limited to Safety Glasses and Hearing Protection.
WORK ENVIRONMENT & CONDITIONS
Works primarily in an office environment with occasional exposure to manufacturing and warehouse areas.
MENTAL OR VISUAL DEMAND
Continuous visual attention required in process of reviewing, handling and processing documents and their associated change requests and other clerical tasks. Requires ability to think critically to coordinate efficient planning and scheduling of audits and times to meet with internal stakeholders related to document control requests, updates and other tasks. Requires constant awareness of standardized processes, personnel training assignment changes, audit schedules. Results oriented with a sense of urgency and motivation to drive results.
ATTENDANCE
Regular attendance is essential to the smooth operation of our company and shows respect for the department personnel, including team members and your manager who may do your job in your absence. It is necessary for you to report to work regularly and on time.
SAFETY
Be active participant in the company’s safety culture by following safe practices and performing duties in accordance with acceptable, safe work procedures and Fujimi approved operating standards.
FLSA STATUS
Non-Exempt
EEO CLASSIFICATION
Administrative Support Workers
The company has reviewed this job description to ensure that essential functions and basic duties have been included. It is intended to provide guidelines for job expectations and the employee’s ability to perform the position described. It is not intended to be construed as an exhaustive list of all functions, responsibilities, skills and abilities. Additional functions and requirements may be assigned by supervisors as deemed appropriate. This document does not represent a contract of employment, and the company reserves the right to change this job description and/or assign tasks for the employee to perform, as the company may deem appropriate.
EEO Statement
Fujimi Corporation provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws. This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation and training.
Reasonable Accommodations Statement
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. Reasonable Accommodations may be made to enable qualified individuals with disabilities to perform the essential functions.
