document control specialist.

The Document Control Specialist is responsible for administration of quality management system documents and records required for companies Life Sciences processes. Responsible for initiation of document changes, distributions, notifications and fulfilling internal and external document distribution.  This position is needed to assist with a major project with changes to the documentation system and preparing for an audit.  Must be able to work 100% ONSITE.   Qualifications:

• Associates or Bachelors and minimum of 2 years relevant work experience, preferably in a manufacturing environment
• 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
• Extremely organized with ability to use multiple resources in comparing documentation
• Must be detail oriented and accurate in execution of work
• Able to work well both independently and in a group setting

salary: $28 - $32.07 per hour
shift: First
work hours: 8 AM - 5 PM
education: Bachelors

Responsibilities

• 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

Skills

Technical

Document Control

ETQ

Document Management

ISO 9001

Quality Systems

Qualifications

Years of experience: 2 years

Experience level: Experienced

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Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.

At Randstad, we welcome people of all abilities and want to ensure that our hiring and interview process meets the needs of all applicants. If you require a reasonable accommodation to make your application or interview experience a great one, please contact HRsupport@randstadusa.com.

Pay offered to a successful candidate will be based on several factors including the candidate's education, work experience, work location, specific job duties, certifications, etc. In addition, Randstad offers a comprehensive benefits package, including health, an incentive and recognition program, and 401K contribution (all benefits are based on eligibility).

This posting is open for thirty (30) days.