Job Title: Document Control Specialist

Department: Quality

Position Type: Full-Time

Location: Onsite (Salt Lake City) / Hybrid

POSITION OVERVIEW:

Performs document control activities for Quality Management Systems (QMS) records and documentation that include maintenance of all quality records, obtaining signatures for change control, tracking, copying distribution of controlled documents and compliance with current Good Manufacturing Practices (cGMP) and Good Documentation Practices (GPD).

-> To be considered, please apply on our website: https://blackrockneurotech.com/careers/

QUALIFICATION REQUIREMENTS

• High School diploma required. Associate degree or above preferred or equivalent education in quality-related courses
• Certification(s) is preferred
• Minimum 5 years of combined document control and quality assurance experience
• Must have minimum 3 years of experience in quality assurance methodologies and product development processes
• Must be familiar with internal auditing and FDA/ISO facility inspections
• Must be able to work independently with little supervision and have problem-solving skills
• Must be able to handle stressful situations, have people skills, and effectively interface with all company departments
• Must have good organizational skills, detail oriented, and excellent editing skills
• Must be proficient in computer skills
• Must be knowledgeable with either ISO 9001 and/or ISO 13485

IDEAL COMPETENCIES

• Operational experience with electronic Quality Management Systems, like MasterControl, preferred
• Experience monitoring and managing organizational training records a plus

ESSENTIAL JOB DUTIES

• Creation and revision of change control documentation including technical reviews for process change, change notifications, change orders, temporary deviations, and batch record validations
• Controls and files all manufacturing and quality records
• Controls, routes, and files deviations, material review board documents (MRB’s)
• Works with all departments to ensure good documentation practice (GDP)
• Responsible for routing documents and change control forms for approval
• Responsible for maintaining approved supplier list, responsible for sending out and maintaining supplier questionnaire files
• Responsible for maintaining and updating our calibration registry
• Maintains and updates other controlled documents as assigned
• Trains document users on document control practices
• Supports project management team to ensure timely delivery of documentation for projects
• Performs other duties as assigned

Physical and other requirements

• Stooping: Bending body downward and forward by bending spine at the waist
• Reaching: Extending hand(s) and arm(s) in any direction
• Mobility: The person in this position needs to occasionally move between work sites and inside the office to access file cabinets, office machinery, etc.

The above information within this job description is designed to present the most essential job duties and responsibilities necessary to achieve the job's end results. It is not intended to be a comprehensive list of all duties, responsibilities, and qualifications.

Job Type: Full-time

Pay: $50,000.00 - $70,000.00 per year

Benefits:

• 401(k)
• 401(k) matching
• AD&D insurance
• Dental insurance
• Disability insurance
• Employee assistance program
• Flexible schedule
• Flexible spending account
• Health insurance
• Health savings account
• Life insurance
• Paid time off
• Parental leave
• Referral program
• Tuition reimbursement
• Vision insurance

Schedule:

• Monday to Friday

Experience:

• ISO 9001 and/or ISO 13485: 1 year (Preferred)
• quality assurance: 1 year (Preferred)
• document control: 1 year (Preferred)

Work Location: Hybrid remote in Salt Lake City, UT 84108