QA Documentation Specialist Position Available In Rensselaer, New York

QA Documentation Specialist Job Employer Name:

ND Global Consulting Services Inc

SpiderID:

14010109

Location:

East Greenbush, New York

Date Posted:

6/9/2025

Wage:

$40/hr

Category:

Biotech

Job Code:

Number Of Openings:

1

Job Description:

A QA Documentation Specialist is needed to perform the following duties:

• Manage Quality Events related to GMP manufacturing Training, Own the Training Curriculum for this process. Train and support to new associates joining this position.
• Create, Review, and organizing documentation, inclusive of Standard Operating Procedures (SOPs), Work Instructions (child document of the SOP) and Protocols which are utilized for performing tasks utilizing the machinery.
• Perform Investigations into quality incidents and deviations related towards product manufacturing processes, by performing root cause analysis and implement corrective & preventive actions to prevent the deviation from reoccurring.
• Participate in risk assessment exercises and support the implementation of risk mitigation strategies.
• Implement a robust document control system using Veeva Vault, resulting in improved efficiency and reduced errors. To conduct document audits to identify gaps and areas for improvement and implemented corrective actions as necessary.
• Effectively oversaw change controls, emphasizing quality considerations, and spearheaded the implementation of more efficient procedures.
• Teamed up with Subject Matter Experts (SMEs) to evaluate and execute change controls, fostering feedback loops and enabling ongoing enhancements.
• Engaged with Chief Manufacturing Officers (CMOs) and external vendors, fostering smooth collaboration and adeptly resolving challenges.
• Collaborate actively within the team, conduct quality reviews and championing continuous process enhancements.
• Implement document control processes using Veeva Vault, overseeing document lifecycles from creation to archival.

Collaborate with cross-functional teams to gather information and ensure accuracy and completeness of documentation.

Job Requirements:

Bachelor’s Degree in Mechanical Engineering.

Job Criteria:

Start Date:

10/1/2025

Position Type:

Full-Time Permanent

Years of Experience Required:

2

Education Required:

Bachelors

Overnight Travel:

Vacation Time:

Job Benefits:

Health/Dental Benefits, Paid Holidays, Vacations, and Sick Leave Contact Information:

Contact Name:

Rashmi Kumari

Company Type:

Staffing Agency

Company:

ND Global Consulting Services Inc City:

Tampa, Suite 250

State:

Florida Zip:

33647