Quality System Specialist

The Quality Systems Specialist supports the execution and maintenance of the Quality Management System (QMS). This role focuses on document control, formatting and compliance review of records, and coordination of QMS activities including deviations, CAPA, and change control. The position provides day-to-day operational support to ensure quality systems are maintained in a compliant and efficient manner under the direction of Quality Management.

ESSENTIAL DUTIES AND RESPONSIBILITIES:

Execute document control activities including issuance, formatting, routing, version control, and archival of SOPs, Work Instructions, forms, logbooks, protocol, batch records and all other controlled records. Format, edit, and perform compliance-based reviews of controlled documents to ensure consistency with company standards and regulatory requirements. Coordinate document workflows to ensure timely review, approval, and training assignment. Review completed records for preventative maintenance, calibration, pest control, and other GxP-related services for accuracy, completeness, and compliance. Document and elevate discrepancies identified during record review to Quality Management. Provide administrative and coordination support for core QMS processes, including: Deviations (initiation support, tracking, documentation completeness checks) CAPA (tracking, follow-up, and documentation support) Change Control (workflow coordination, completeness review, tracking) Lab investigation (tracking, follow-up, and documentation support) Ensure QMS records are complete, accurate, and maintained in the eQMS in a timely manner. Maintain and update data within the electronic Quality Management System (eQMS). Support QA, production, warehouse, R&D and analytical team as needed basis for quality documents for core QMS processes Support training coordination by assigning, tracking, and maintaining training records related to controlled documents. Assist with audit preparation by organizing documentation and retrieving records for internal and external audits. Compile and track basic quality metrics (KPIs) for reporting purposes. Support / generate data for quality review board and quality management system review meeting. Support continuous improvement initiatives by identifying inefficiencies in document control and QMS processes. Collaborate cross-functionally to support compliance with internal procedures and regulatory requirements. Perform other quality system support activities as assigned by Quality Management.

QUALIFICATIONS AND EXPERIENCE:

Bachelor’s degree in a scientific or related discipline preferred; equivalent experience may be considered. 3–5 years of experience in Quality Systems, Quality Assurance, or related GxP environment. The candidate needs to be highly motivated, well-organized, and detail-oriented who can work effectively in a fast-paced and multi-disciplinary environment. Experience of GMP document control systems, change control, non-conformances, CAPAs, and Quality Management System maintenance Understand the requirements and procedures related to Quality Assurance and Compliance. Demonstrated knowledge of industry regulations and best practice standards including but not limited to the following: 21 CFR Part 210 & 211, 21 CFR Part 11, 21 CFR Part 820, 21 CFR 1300, EU Annex 11, EudraLex Volume 4, ISO 13485, ISO 14971, ISO 9001 etc.

COMPETENCIES/SKILLS:

Strong attention to detail, particularly in document formatting and record review. Highly organized with strong administrative and coordination skills. Ability to follow defined procedures and elevate issues appropriately. Effective communication skills with the ability to work across departments. Ability to manage multiple tasks and meet deadlines in a structured environment. Ability to work independently and collaboratively within cross-functional teams. Proficient in Microsoft Office Suite (Word, Excel, PowerPoint, Outlook) and general computer systems. Enter data into computer using software applications for data entry, data analysis, statistical analysis, and word processing. Team-oriented with a willingness to support broader quality initiatives. Ability to work flexible hours as needed. Ability to work under pressure and meet deadlines. Basic knowledge of six sigma and quality tools.

SUPERVISORY RESPONSIBILITIES:

Not Applicable

WORK ENVIRONMENT:

Standard office environment Occasional overtime may be required to support creating documents and review and project deadlines.

SCHEDULE:

Mon – Fri, Hybrid – 4 days on site, 1 day WFH

SALARY RANGE:

$80,000 - $100,000

PHYSICAL DEMANDS:

While performing the duties of this job, the employee is frequently required to stand, walk, use hands to touch, handle or feel, and talk or hear. The employee is occasionally required to sit and reach with hands and arms. Ability to lift and/or move up to 20 pounds frequently preferred. The employee is occasionally required to sit and reach with hands and arms. Specific vision abilities required by this job include close vision, distance vision, color vision, peripheral vision, depth perception and ability to adjust focus.

TRAVEL:

Domestic travel will be required less than 10% of the time. This job demands described here are representative of those that must be met by an employee to successfully perform the functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. This job description is not intended and should not be construed to be an exhaustive list of all responsibilities, skills, efforts, or working conditions associated with the job. It is intended to be a reflection of those principal job elements essential for recruitment and selection, for making fair job evaluations and for establishing performance standards. The percentage of time spent performing the various job duties is not absolute. The incumbent shall perform all other functions and/or be cross trained as shall be determined by the sole discretion of management, who has the right to amend, modify, or terminate this job in part or in whole. This document is not a contract for employment. EXPERIC is an Equal Opportunity Employer, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law. #J-18808-Ljbffr Experic