Quality Assurance (QA) Documentation Specialist I

Description

Company Overview

Creating a Healthier World through Accessible Biologics:

Kashiv BioSciences, LLC is a fully integrated biopharmaceutical company. Kashiv BioSciences, LLC in the United States, and its subsidiary, Kashiv BioSciences Private Limited in India (together “Kashiv BioSciences”), operate together with robust infrastructure and highly skilled teams that provide global R&D, clinical, manufacturing, regulatory, and IP capabilities. We believe our people, partners, and shared purpose fuel our work to advance patient care and access to important medicines.

Position Summary

The Documentation Specialist I is a regular employee in a full-time position at Kashiv BioSciences, LLC, in Chicago, IL. The employee is responsible for assisting with the review, issuance, control, formatting, reconciliation, and archival of procedures, forms, test methods, and related controlled documents throughout the organization. The Documentation Specialist I will also support maintenance of employee training files and training curricula to help ensure employees remain current in assigned training.

Essential Duties & Responsibilities 

• Assist with issuing and controlling, but not limited to, Master Batch Records, Controlled Forms, Logbooks, Test Methods, Protocols, and Reports. 
• Assist with issuing and routing Document Change Requests (DCRs) in the Electronic Document System. 
• Scan batch records, validation documentation, calibration information, and supporting documentation, and post to the company portal as needed. 
• Assist with auditing issued Controlled Forms, Master Batch Records, and Logbooks to support reconciliation and timely return of documents for final archival. 
• Receive documentation and ensure documents are properly archived and easily retrievable. 
• Ensure documents are properly formatted. 
• Assist with template management to support harmonization among documents within the organization. 
• Assist with tracking lead times for Document Change Requests. 
• Provide routine status updates for pending document reviews in the Electronic Document System, as requested. 
• Provide basic user support for the documentation system, including creation and monitoring of incident tickets requiring help desk support from the Electronic Document System Administrator. 
• Assist change originators with coordination of document releases. 
• Support implementation of efficiency improvements to the overall document control process. 
• Assist the training team by tracking training files and completion of training modules. 
• Upload PDF versions of procedures to the corporate portal. 
• Support assigned projects and activities to meet the needs of Quality Management. 
• Perform other duties and responsibilities as delegated by Quality Management. 

Requirements

Position Requirements and Qualifications

Minimum Qualifications:

Education: 

• An associate degree or bachelor’s degree in life science, computer science, or other related field; or 1–2 years of experience in a training and/or document control capacity, preferably in a cGMP-regulated industry.

Preferred Qualifications: 

Experience: 

• Previous experience working in document control in training or a similar capacity is preferred. 
• Previous experience with electronic document management systems is preferred. 
• Previous work in a cGMP industry is preferred.

Certifications, Licenses, etc.: 

• MasterControl™ Electronic Document Management System Operation certification is preferred.  

Compensation:

• Quality Assurance (QA) Documentation Specialist I – Base Salary Range and Yearly Bonus (0–2 years or more of manufacturing biologics/biosimilars Quality Assurance experience) - $60,000 to $65,000 (dependent on years of experience and fit for the position) with up to an 8% yearly (discretionary) cash bonus

Benefits/Perks:

• Medical Insurance - Aetna
  • Prescription Drug Converge | Rx
  • Virtual Visits - Aetna/Teladoc
  • Health Savings Accounts (HSA)
  • Flexible Spending Accounts (FSA)
• Dental Insurance - Aetna
• Vision Insurance - VSP
• Life and AD&D Insurance
• Disability Benefits
• Supplemental Benefits
  • Legal Services
  • ID Theft Protection
  • Travel Assistance
• Value Added Benefits & Services
  • Health Advocate
  • Life Assistance Program (LAP)
  • Student Loan Assistance Program
• 401K
• Monthly Cell Phone Allowance
• Free Parking (Company Paid)
• Conveniently located next to the Metra, Green and Red Line
• One block east of the Chicago White Sox Stadium
• Less than 10 minutes away from Downtown Chicago

Hours:

This position is onsite 5 days a week from 9 AM EST to 5:30 PM EST

Work Environment & Physical Demands: 

General work environment and physical demands as required to successfully perform the essential functions of this job. Ability to work flexible hours as needed. Ability to work under pressure and meet deadlines.  

Supervisory Responsibility, if any: No

This position description is not a complete list of all responsibilities, duties or skills required for the job and is subject to review and change at any time, with or without notice, in accordance with the needs of the organization.

L10 minutes away from Downtown Chicagont opportunities (EEO) to all employees and applicants for employment without regard to race, color, religion, sex, national origin, age, disability, or genetics. In addition to federal law requirements, Kashiv BioSciences, LLC complies with applicable state and local laws governing nondiscrimination in employment in every location in which the company has facilities. This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, and transfer, leaves of absence, compensation, and training.