A Document Control Specialist is needed for a manufacturing company considered one of the world's leading innovators in materials science in the Kennebunk, ME area. This role is crucial for maintaining the integrity and compliance of the company's quality management system documentation, ensuring that all records are accurate, up-to-date, and accessible as required.
location: Kennebunk, Maine
job type: Contract
salary: $18.32 - 29.28 per hour
work hours: 8am to 4pm
education: Associates
responsibilities:
- Generate, review, and maintain quality system documents, including procedures, work instructions, job aids, and certificates of conformance, ensuring compliance with ISO 13485, ISO 9001, and 21 CFR 820 standards.
- Initiate Change Controls and Document Change Requests to update procedures and processes.
- Collaborate with various departments to update processes and procedures.
- Assist in managing the document review and retention processes.
- Support or lead continuous improvement initiatives for document control-related processes.
- Support other Quality Assurance functions as needed, such as internal audits and Corrective and Preventive Actions (CAPAs).
- Perform other duties as required.
- Previous experience using ETQ or other Document Management software is preferred.
- Proficiency in Microsoft Office, particularly Excel.
- Experience with ISO 9001 or other Quality System standards.
- Knowledge of ISO 13485 and 21 CFR 820 Quality Management Systems is highly preferred.
- Must be detail-oriented and accurate in the execution of work.
- Ability to work well both independently and in a group setting.
- An Associate or Bachelor's degree in life sciences, engineering, or a related field is preferred.
- A minimum of 2 years of related experience.
- Prior experience in a manufacturing environment is preferred.
qualifications:
- Experience level: Experienced
- Education: Associates
skills:
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.
