Quality Systems Documentation Specialist - Onsite

Aptask Global Workforce (AGW) is seeking a Quality Systems Documentation Specialist for an Onsite position with a Global Pharmaceutical Company located in Durham, NC. This is a 6+ month contract opportunity.

This role is responsible for managing quality systems documentation, including document issuance, reconciliation, and archiving within a GMP biopharmaceutical environment. The ideal candidate will utilize an electronic document management system (Veeva) and ensure adherence to Good Documentation Practices (GDP).

Responsibilities:

• Perform document issuance and reconciliation using an electronic document management system (Veeva)
• Provide archiving assistance in the High Density Storage Room (HDSR)
• Assist system owners to keep the site inspection ready
• Update a Record Inventory Management System (PRIMS) for archived paper documents, including archiving documents and completing check-out requests
• Help organize paper batch records from SAP for issuance
• Ensure appropriate Good Documentation Practices (GDP) when entering data into the system
• Guide others on Quality System procedures and processes

Requirements:

• Associate degree or High School Diploma with 2+ years of related GMP Biopharma experience (Bachelor's degree is preferable)
• Knowledge of electronic document management systems, such as Veeva
• Experience with archiving or organizing physical documents
• Proficient data entry computer skills
• GMP experience
• Excellent written and verbal communication skills
• Strong organizational and detail-orientation skills
• Ability to be collaborative and escalate issues when necessary

Desired skills:

• SAP/ERP experience
• Experience in the Biotech, Pharmaceutical, or Medical Device industry

Pay range: up to $29.25 per hour

Only candidates available and ready to work directly as Aptask Global Workforce (AGW) employees will be considered for this position.

If you have the described qualifications and are interested in this exciting opportunity, apply today!

Aptask Global Workforce (AGW)

ApTask Global Workforce (AGW) is a certified Minority and Veteran workforce solutions company. AGW delivers operational, clinical, lab and professional talent with a strong focus on healthcare and life sciences. The company supports clients with reliable staffing, program expertise and a commitment to quality, speed and consistent delivery.

Benefits of working with ApTask Global Workforce include:

• Medical
• Dental
• Vision
• Sick Pay (for applicable states/municipalities)

Our team stays close to the process and is here to guide you every step of the way. To learn more, please visit our website

ApTask Global Workforce is an Equal Opportunity Employer. Candidates will receive consideration without regard to their race, color, religion, sex, sexual orientation, gender identity, national origin, disability or status as a protected veteran.

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