The Associate, Quality Assurance Documentation, will assist in maintaining and administering all aspects of the GMP document control system compliant with international cGMP expectations and Company policies and procedures.
location: Marlborough, Massachusetts
job type: Contract
salary: $24 - 29 per hour
work hours: 9 to 5
education: Bachelors
responsibilities:
- Document Issuance Support: Assist with the issuance of GxP documentation utilizing the Veeva Document Management System.
- Document Reconciliation Support: Assist with the reconciliation of returned GxP in the Veeva Document Management System and final disposition of reconciled documents.
- Document Control Support: Provide assistance with document control-related activities, including procedure creation and revision, as needed.
- Training Documentation Support: Provide assistance with creation of training folders and filing for associated training documentation in the Document Control room.
- Collaboration with Department Stakeholders: Assist with implementation of document change requests to ensure GxP documents are provided in a timely manner to stakeholders after creation or revision of a document.
- Documentation Discrepancy Resolution: Assist with investigating discrepancies related to missing or misplaced documentation.
qualifications:
Required:
- A relevant Master's degree and no industry experience
- If no Master's, would accept a BA/BS degree and 1+ years of relevant experience
- Proficiency with Microsoft Word
- An ability to collaborate and communicate effectively
- Prior experience with Document management software within a regulated industry (Example: Veeva Vault)
- Proficiency with Excel, PowerPoint or Visio proficiency
- Prior experience with FDA, GLP and cGMP
skills: MS-WORD, MS-EXCEL, MS-Powerpoint, GLP (Good Laboratory 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.
It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.
