Document Control Specialist
Responsible for administration of quality management system documents and records required for Clients Life Sciences processes. Responsible for initiation of document changes, distributions, notifications and fulfilling internal and external document distribution.
Description of Work:
Generates, reviews, and maintains quality system documents including procedures, work instructions, job aids, certificate of conformances, etc. in compliance with ISO 13485, ISO 9001, and 21 CFR 820 standards.
Initiates Change Controls and Document Change Requests to update procedures and processes.
Works within departments and with various departments to update processes and procedures.
Assists in managing the document review and retention processes.
Supports or leads continuous improvement initiatives for document control related processes.
Supports other Quality Assurance functions as needed (internal audit, CAPAs, etc.)
Other duties as required
Minimum Qualifications:
Associate or bachelor's Degree, 2+ years of work equivalent experience (work in a manufacturing environment is preferred).
Skills/Experience:
Previous experience using ETQ or other Document Management software preferred
Proficiency in Microsoft office
Experience in ISO 9001 or other Quality System standards
ISO 13485 and 21 CFR 820 Quality Management Systems knowledge highly preferred
Must be detail oriented and accurate in execution of work
Able to work well both independently and in a group setting
...Poly (unarmed) Location : Aurora, CO Interview Process: 1-Round; Virtually via Microsoft Teams Pay Rate : $35/hour (max) Start date : 2-4 weeks following offer Shift : Monday - Thursday 5:45am - 4:00p MST OT available weekly; Fri/Sat are...
...LHH Recruitment Solutions is seeking an Accountant/ Financial Analyst. This role is ideal for a finance professional with a strong foundation in accounting, public accounting experience (audit & assurance), and ideally, exposure to the manufacturing industry. The position...
...continuous improvement initiatives Proficiency using various IT devices and programs, Laptop PCs, tablets, MS Office OSHA 10-hour course Participate in field quality control Complete Standards of Excellence quality checklists at appropriate times The above...
...Are you looking for a Meaningful and Fulfilling Career? A.G. Rhodes Care Solutions is currently hiring Registered Nurse (RN) Care partners to work at our three Metro Atlanta communities, and we would love the opportunity to work with you!! We are proud to be one...
.... VitalCore Health Strategies (VCHS), an industry leader in Correctional Healthcare, has an opening for a Medical Director / Physician at Charles B. Webster Detention Center in Augusta, GA for Part-Time (20 hours/week)! At VitalCore we pride ourselves on retaining...