The Quality System Document Control (QSDC) Administrator is responsible for handling all Quality System controlled documents (Standard Operating Procedures (SOPs), Work Instructions (WIs), Forms, Policies, Knowledge Assessments (KAs), among others). The QSDC Administrator will circulate and track the documents through the review, approval and distribution process. The QSDC Administrator will upload and link the documents into the Document and Training System.
location: Ridgefield, New Jersey
job type: Contract
salary: $20 - 35 per hour
work hours: 9 to 5
education: Associate
responsibilities:
- Assist Batch Release with the review/scan and archive of Autoclave chart, EM package, etc
- Assist batch record on review /release of intermediates process
- Maintain all controlled documents and assist company personnel with the creation and revision of all controlled documentation (i.e. SOPs, Forms, Scanning to SharePoint, etc.).
- Initiate the periodic review process for controlled documents by their due dates and associated metrics.
- Ensure adherence to established templates and procedures.
- Verify document change requests, perform review of documents for accuracy and consistency before circulating for approval.
- Scan, image, organize, and maintain documents.
- Archive inactive records in accordance with the records retention schedule.
- Assist with audit preparation and audit support as required.
- Maintain curricula, learning plans, and training records, record training and learning events via the internal Training Management System.
qualifications:
Required Qualifications
- Education: Associate's Degree.
- Experience: 0-3 years of experience in the pharmaceutical or a related regulated industry.
- Compliance: Basic understanding of FDA, ICH, EMA, and GCP guidelines.
- Communication: Fluency in written and spoken English with strong interpersonal and diplomacy skills.
- Attention to Detail: High level of accuracy in detecting errors or deficiencies during document review.
- Technical Literacy: Proficiency in using electronic document templates.
- Organization: Ability to manage workload priorities and work effectively within a team.
- Mentorship: Ability to act as a trainer or mentor to other staff members.
- Operational Knowledge: Working knowledge of biostatistics, data management, and clinical operations procedures.
- Influence: Strong team-building and influencing skills to support internal stakeholders.
- Technical Support: Experience providing direct guidance and assistance to document authors.
skills: SOP Development, Good Clinical Practice (GCP), European Medicines Agency (EMA), International Council for Harmonization (ICH)
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: medical, prescription, dental, vision, AD&D, and life insurance offerings, short-term disability, and a 401K plan (all benefits are based on eligibility).
This posting is open for thirty (30) days.
