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

Kashiv BioSciences, LLC is a fully integrated biopharmaceutical company with robust infrastructure and highly skilled teams providing 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.

About the role

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, Change Controls, and Market Complaints. Key responsibilities include ensuring quality control and manufacturing operations have proper QA oversight, managing Nonconformances, OOS Investigations, and Deviations.

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.
• Support 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

• Bachelor’s or master’s degree (preferred) in Life Science, Biotechnology, Pharmacy, Microbiology, or other scientific-related discipline.
• 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.
• Understanding of requirements and procedures related to document control and Quality Assurance.

Skills

• 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.

Pay

Base salary range: $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

• Medical Insurance - Aetna
• Prescription Drug Coverage | 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)

Additional perks: Conveniently located next to the Metra, Green and Red Line, one block east of the Chicago White Sox Stadium, and less than 10 minutes away from Downtown Chicago.

Schedule

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.