Quality Control Specialist

JOB SUMMARY

The Document Control Coordinator is responsible for executing and providing leadership to the document control process and documentation of company records. This role focuses on optimizing document hierarchy and organization structure, consolidation of documentation to reduce confusion and compliance risks, as well as driving change controls processes. The coordinator will also support document retrieval and record keeping during audits, assist in completing training record keeping, and support calibration as needed. The position plays a key role in reviewing compliance in records and documentation processes.

ESSENTIAL DUTIES & RESPONSIBILITIES

• Leads the reviewing of documentation, documentation workflows, and documentation processing for continuous improvement and compliance to standards.
• Supports Internal and External Audits with documentation retrieval and preparation. Support Lead Auditor with execution of Internal Audits.
• Supports and review the calibrated tools system, record keeping and documentation of calibration in compliance with industry standards.
• Trains, mentors, and develops team members.
• Leads the maintenance and updates Document Matrices and Master Document Lists.
• Collaborates with departments’ leads to streamline knowledge management and SOP development.
• Performs Project management or project execution.
• Delivers training on documentation updates.
• Ad-hoc projects as needed.

QUALIFICATION REQUIREMENTS

• To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

EDUCATION AND/OR EXPERIENCE

• Bachelor's degree in quality management, Business Administration, Information Management, or a related field preferred.
• 3+ years of experience in document control, quality management, or compliance, preferably in a regulated industry.

KNOWLEDGE, SKILLS, AND ABILITIES

• In-depth knowledge of document control principles, quality management systems, and industry regulations (ISO, FDA, GMP).
• In-depth knowledge of required Quality System areas for compliance to ISO standards.
• Strong analytical and problem-solving skills with a process improvement mindset.
• Proficiency in Microsoft Office Suite and document management systems; experience with electronic quality management systems (eQMS) preferred.
• Excellent project management skills, with the ability to manage multiple priorities.
• Strong communication and training abilities to educate staff on quality system requirements.

TRAVEL

• Up to 10% for audits, training, or regulatory meetings.

PHYSICAL DEMANDS & WORK ENVIRONMENT

This role is office-based with occasional exposure to manufacturing environments.

The physical demands for this role include standing for extended periods, frequent walking, and performing repetitive motions such as bending, lifting, and reaching. There may be times that involve prolonged periods of sitting at a desk, using a computer, and engaging in repetitive hand movements for tasks like typing or writing. Employees must be able to lift and move objects up to 50 pounds regularly and occasionally heavier items with assistance. The role may involve operating machinery, using hand tools, and maintaining precise hand-eye coordination. Good vision, hearing, and manual dexterity are essential for safely performing tasks and ensuring product quality.

The work environment for this role is in a manufacturing facility with machinery, tools, and materials, requiring adherence to safety protocols and the use of personal protective equipment (PPE). Noise levels can be high, and tasks may involve lifting or moving parts. Minimal time will be spent in wet or humid conditions, and near caustic or toxic chemicals.

Pay: $68,006.00 - $86,141.00 per year

Benefits:

• 401(k)
• 401(k) matching
• Dental insurance
• Flexible spending account
• Health insurance
• Health savings account
• Paid time off
• Parental leave
• Vision insurance

Work Location: In person