Manufacturing Quality Assurance (MQA) Specialist I, II, & III

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 Manufacturing Quality Assurance (MQA) Specialist I, II, and III is responsible for supporting and ensuring compliance with current Good Manufacturing Practices (cGMP), Company procedures, and regulatory requirements across manufacturing, laboratory, warehouse, engineering, validation, and quality systems activities. This role provides quality oversight for manufacturing operations, raw material release, batch record review, facility audits, and quality event management to ensure products are manufactured, tested, and released in accordance with established quality standards. The MQA Specialist partners closely with cross-functional teams to promote a culture of quality, drive continuous improvement initiatives, and support the successful manufacture of biologics and biosimilar products. The level of responsibility, technical expertise, and independent decision-making will vary based on the MQA Specialist level (I, II, or III) and corresponding experience.

Essential Duties & Responsibilities

• Performs inspection, sampling, and testing where applicable on all incoming materials, packaging components, and returned goods following detailed written procedures.
• Ensures smooth flow of raw material and critical material testing through routine follow-up with internal and external laboratories.
• · Perform the cleaning and sanitization of the ISO 7 area and the ISO 5 Laminar flow hood, as per written procedures. 
• Assigning and verification of expiry date and retest date for all the GMP raw materials through vendor COA and/or in-house COA. 
• Perform review and release of Raw Materials and Critical Materials.
• Review of documentation supporting batch, laboratory, warehouse, metrology, engineering, and validation activities to ensure they are complete and in compliance with company policies and procedures and cGMP requirements.
• Review of documentation supporting quality event system investigations (e.g., change control, deviations, out of specifications, complaints, etc.) prior to final disposition.
• Assist with quality assurance procedures governing the facility quality event system and ensure compliance with cGMP regulations, customer expectations, and company policies.
• Ensure quality events are appropriately cross-referenced and that completed events are included in batch documentation prior to final disposition.
• Perform quality assurance walk-through audits of manufacturing, laboratory, and warehouse areas to ensure compliance with cGMP’s and company procedures.
• Provide backup for other Quality Assurance Specialist responsibilities.
• Assist and provide input as part of a project team to resolve quality and manufacturing issues and identify and implement corrective and preventive actions in a timely manner.
• Assist on a broad spectrum of projects to support the needs of Quality Management.
• Perform other duties and responsibilities as delegated by Quality Management.

Requirements

Minimum Qualifications:

Education:

• A 4-year Bachelor's degree, preferably in a science or engineering discipline

Experience:

• Previous experience for MQA I (0 to 2 years or more), MQA II (2 to 5 years or more), and MQA III (5 plus years) in a cGMP biologics/biosimilars manufacturing laboratory environment is required.
• Working knowledge of cGMP regulations (21 CFR210/211/820) is desired.
• Working knowledge of Deviation, CAPA, Change Control, and Validation/Qualification (IQ/OQ/PQ) is desired.
• Certification from professional organizations such as ASQ and ISPE is desired but not required.  

Preferred Qualifications: 

SPECIALIZED KNOWLEDGE AND SKILLS: 

• Ability to work independently or in teams both within the department and cross-functionally. Must be able to organize, plan, and manage assigned tasks to bring projects to completion.
• Strong communication skills, both written and verbal.
• Excellent organizational skills and detail-oriented. Must have excellent time management skills and the ability to effectively prioritize assignments.
• Must be able to coordinate projects and activities with other quality assurance staff.
• Excellent computer skills in Microsoft Office applications.
• Experience authoring technical reports and creating templates.
• Must be able to utilize technical information appropriately to ensure documents produced are consistently clear, concise, accurate, and complete.

Compensation:

• MQA I Specialist – Base Salary Range and Yearly Bonus (0–2 years or more of manufacturing biologics/biosimilars Quality Assurance experience) - $70,000 to $75,000 (dependent on years of experience and fit for the position) with up to an 8% yearly (discretionary) cash bonus
• MQA II Specialist - Base Salary Range and Yearly Bonus (2-5 years or more of manufacturing biologics/biosimilars Quality Assurance experience) - $80,000 to $85,000 (dependent on years of experience and fit for the position) with up to an 8% yearly (discretionary) cash bonus
• MQA III Specialist - Base Salary Range and Yearly Bonus (5 plus years or more of manufacturing biologics/biosimilars Quality Assurance experience) - $90,000 to $95,000 (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

Hours:

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

WORKING ENVIRONMENT/PHYSICAL REQUIREMENTS:

• Typing, desk work, and plant auditing.
• Must be able to read, write, and understand English.
• Manufacturing clean rooms. Some brief and/or minimal exposure to hazardous chemicals may occur, requiring personal protective equipment.
• Safety alertness is required due to working around hazardous equipment and conditions.
• 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.

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, transfer, leaves of absence, compensation, and training.