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location: Sanford, North Carolina
job type: Contract
salary: $35.00 - 42.16 per hour
work hours: 9 to 5
education: High School
responsibilities:
- Reporting to the Associate Director, Quality Assurance (QA) Document Control (DC) and Data Integrity, the DC Associate, QA will have responsibilities for the technical and administrative support of the GxP regulated functional departments and their clients.
- Activities will include, but are not limited to:
- assessment of sitewide procedures
- documents and records to support compliant GMP operations at the Sanford, NC manufacturing facility.
- ensuring adherence to agency regulations (GxP) and guidance, industry best practices, local regulations, and internal policies and procedures.
qualifications:
- Facilitate the life cycle of master documents (including but not limited to SOPs, Batch Records, Test Methods, Protocols, Reports, Specifications, etc.) by functioning as a document workflow coordinator
- Review, edit, format master documents according to approved procedures and templates, maintains document properties (metadata), monitor document status and approval notifications, distributions and archiving
- Collaborate with cross-functional departments to ensure timely implementation of document change requests and change control associated tasks
- Issue effective documents including logbooks, procedures, test methods, specifications, batch documentation and labels and maintain issuance logs
- Execute duties associated with controlled document change requests (i.e., document formatting, approvals, effectiveness, and distribution)
- Assist with and provide on-going user support for electronic document management system
- Provide day-to-day operation support for departments (e.g. scheduling, reporting, records archiving)
- May also support the preparation and assisting as needed, during internal audits and/or regulatory inspections.
skills: Quality control, SOP, Quality Assurance, GLP (Good Laboratory Practice), GCP (Good Clinical Practice), GMP (Good Manufacturing Practice)
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.
