Quality Management System (QMS) Specialist I, Quality Assurance (QA)

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 QMS Specialist I, QA is responsible for maintaining Kashiv BioScience’s quality management system. This role demands knowledge of laboratory practices, including testing, OOS investigations, and QMS systems such as Deviations, CAPAs, and Change Controls, and Market complaint. Key responsibilities include ensuring quality control and manufacturing operations have proper QA oversight, managing Nonconformances, OOS Investigations, and Deviations. The incumbent will oversee all Quality Assurance team functions, providing guidance for late-stage clinical and commercial biosimilar products, cGMP-compliant laboratories, and manufacturing operations. 

Essential Duties & Responsibilities 

• Administer, track, and maintain Quality Management System records including Deviations, Nonconformances, CAPAs, Change Controls, OOS/OOT Investigations, Complaints, and Risk Assessments.
• Ensure quality events are initiated, investigated, and closed in a timely manner in compliance with established procedures.
• Coordinate cross-functional investigations and facilitate timely completion of action items.
• Supports in review of investigations for completeness, scientific rationale, data integrity, root cause determination, and effectiveness of corrective and preventive actions.
• Support quality risk management activities using applicable risk assessment tools.
• Monitor and analyze Quality System performance metrics.
• Participate in the collection of data, maintain quality database, information retrieval, and documentation management to optimize data management processes.
• Utilize expertise in information management to ensure accurate and efficient management of information generated within the organization.
• Prepare trending reports and management review data related to Deviations, CAPAs, Change Controls, Complaints, OOS investigations, and other quality indicators.
• Support Quality Review Board (QRB) meetings and follow-up activities.
• Draft, revise, review, and maintain SOPs, forms, work instructions, and quality system documents. 
• Ensure controlled documents are maintained in accordance with document management procedures. 
• Maintain accurate, complete, and inspection-ready documentation.
• Review qualification and validation protocols, reports, and associated change control documentation. 
• Support assessment of quality system impacts related to facility, equipment, utility, process, computer system, and analytical method changes. 
• Verify that quality system requirements are incorporated into validation and qualification activities as applicable.
• Participate in regulatory inspections, customer audits, internal audits, and quality assessments. 
• Maintain inspection readiness through continuous monitoring of quality systems and compliance activities.
• Collaborate with Manufacturing, Quality Control, Validation, Engineering, Regulatory Affairs, Supply Chain, and other departments to resolve quality and compliance issues. 
• Provide guidance and support to personnel regarding quality system requirements and GMP expectations. 
• Promote a culture of quality, compliance, and continuous improvement.
• Perform other duties as assigned. 
• Comply with all company policies, procedures, safety requirements, and regulatory standards.

Requirements

Position Requirements and Qualifications 

Minimum Qualifications:

Education

• Bachelor / master’s degree (preferred) in Life Science or biotechnology or pharmacy or microbiology other scientific related discipline.

Experience

• Minimum of 1-3 years of relevant experience in Quality Assurance, Quality Systems, or GMP-regulated pharmaceutical/biotechnology environments.
• Experience managing or supporting Deviations, CAPAs, Change Controls, OOS Investigations, Complaints, and Quality Risk Management.
• Understand the requirements and procedures related to document control and Quality Assurance.

Preferred Qualifications: 

KNOWLEDGE, SKILLS, AND ABILITIES

• Working knowledge of FDA regulations, 21 CFR Parts 210, 211, and 11.
• Understanding of ICH guidelines, data integrity principles, and cGMP requirements.
• Knowledge of investigation methodologies, root cause analysis, and CAPA management.
• Strong technical writing, documentation, and communication skills.
• Ability to manage multiple priorities and meet established timelines.
• Strong analytical and problem-solving skills.
• Proficiency with Microsoft Office applications and quality management software systems.
• Ability to work independently and collaboratively in a cross-functional environment.

Compensation:

• QMS Specialist I – Base Salary Range and Yearly Bonus (10 or more years 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. Flexibility to work additional hours and weekends as needed to support business operations and meet organizational commitments.

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. Ability to remain seated and work at a computer for extended periods of time. Ability to work extended hours as needed to meet business commitments.

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.

Kashiv BioSciences, LLC provides equal employment 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.