Job Description
PURPOSE:
Maintain document control systems and activities; administration of the electronic Quality Management Systems (eQMS); manage support activities for eQMS; manage training within the Learning Management System (LMS). Manage Document Control functions and activities. GENERAL RESPONSIBILITIES
: System Administrator for the electronic Quality Management Systems (eQMS); Manage support activities for eQMS; Manage all document control activities per procedure; Responsible to ensure that the ACC document control system and training program is in compliance with all applicable standards and guidelines; Manage training within the Learning Management System (LMS); Maintain document control databases such that they are up to date and accurate at all times; Perform training as required; Review, approve and release Quality Records such as product history records and manufacturing records and certificates as needed; Prepare for and participate in customer, regulatory and internal audits; Support the generation monthly metrics and reports as needed; Participate in project teams and change controls as the Document Control representative Participate in change management process; Other duties as assigned. KNOWLEDGE AND SKILL REQUIREMENTS
Working knowledge of cGMP, ISO
13485, IVDD, IVDR and other international standards and guidances and principles of document control Detail oriented and excellent organizational skills Ability to work in a fast-paced team environment Ability to work on multiple tasks and meet deadlines Excellent oral and written communication skills Proficiency in all office-based software EDUCATION
5 years' experience working within a quality system and regulated environment. 3+ years working in a Documentation Control function preferred. A minimum of a Bachelor's degree or equivalent combination of experience and/or education required. GENERAL COMPETENCIES
Communicates well (written and verbal), delivers presentations, and has good listening skills Perform tasks with a computer. Email, research, interaction with others via the internet. Creating and editing documents typically utilizing MSOffice; word documents, spreadsheets and create a slide presentation (PowerPoint). The level of proficiency is defined by the requirements of the position held. Good listener, committed to finding solutions to problems, works well with difficult people Works well with internal and external customers, promotes a positive image of the company, and strives to solve issues raised by customers. Meet deadlines, works independently, accountable, maintains focus, punctual, good attendance record. Honest, accountable, maintains confidentiality. Information, organized and accessible, maintains efficient workspace, manages time well. Pursues everything with energy, drive, and a need to finish; seldom gives up before finishing, especially in the face of resistance or setbacks. Manages workload, works efficiently, and meets goals and objectives. Strives to eliminate errors, accurate work is a priority, seeks opportunities to improve product/services, compliant with quality system requirements. PHYSICAL REQUIREMENTS
Constantly sit, occasionally stand, and frequently walk. Occasionally use hands to finger, handle or feel. Occasionally reach with hands or arms, occasionally climb or balance, stoop, kneel, crouch or crawl. Constantly talk. Lift 11 to 25 lbs, 1-33% of the time. Carry 11 to 25 lbs, 1-33% of the time. SALARY:
$65,000-$91,000 a year PAY RANGE DETAILS
The pay range listed on each job posting at acc represents the anticipated compensation range for new hires. Actual compensation will be determined based on several factors, including the candidate's work history, experience, skills, and education. This range does not include the value of the total benefits package (if applicable), which includes, among other benefits, healthcare, dental, vision, and retirement benefits. Annual salaries are based on full-time employment. BENEFITS
401(k) 401(k) matching Dental insurance Employee assistance program Flexible schedule Flexible spending account Health insurance Life insurance Paid time off Parental leave Professional development assistance Referral program Tuition reimbursement Vision insurance
