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

Kashiv BioSciences, LLC•Chicago, IL

4d•$60,000 - $65,000•Onsite

About The Position

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.

Requirements

Bachelor / master’s degree (preferred) in Life Science or biotechnology or pharmacy or microbiology 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.
Understand the requirements and procedures related to document control and Quality Assurance.

Nice To Haves

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.

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.