Quality Assurance (QA) Specialist I, II, & III

Position Summary

Kashiv BioSciences, LLC is a fully integrated biopharmaceutical company operating in the United States and India. The Quality Assurance Specialist supports the Quality Assurance management in ensuring overall product and process quality, compliance with cGMP requirements, and company policies.

Essential Duties & Responsibilities

• Manage a broad spectrum of projects to support Quality Management.
• Issue, assemble, and review documentation supporting batch, laboratory, warehouse, metrology, engineering, and validation activities.
• Interface with cross-functional departments and perform quality assurance walk-through audits.
• Support environmental/quality monitoring and release of controlled systems and environments.
• Aid in resolving quality and manufacturing issues and implementing corrective and preventive actions.
• Perform raw material, water, and gas sampling, in-process, and finish product sampling, and coordinate sample submissions.
• Quality release of raw materials and finished products.
• Provide backup for other Quality Assurance Specialist responsibilities.
• Ensure adherence to GMP good documentation practices.

Position Requirements and Qualifications

• Minimum Qualifications:
• Education: A 4-year Bachelor's degree, preferably in a science or engineering discipline.
• Experience: Previous experience for QA I (0 to 2 years or more), QA II (2 to 5 years or more), and QA 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:
• Good communication skills, both written and verbal.
• Good organizational skills and detail-oriented. Must be able to effectively manage time to complete assignments.
• Excellent computer skills in Microsoft Office applications.
• 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.
• Direct experience in manufacturing QA support (sampling, room/line clearance, cleaning verification) preferred.
• Understand the requirements and procedures related to document control and Quality Assurance.
• Experience in GMP document control.
• Must be able to utilize technical information appropriately to ensure documents produced are consistently clear, concise, accurate, and complete.
• Compensation:
• QA 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 a 8% yearly (discretionary) cash bonus.
• QA 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 a 8% yearly (discretionary) cash bonus.
• QA 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 a 8% yearly (discretionary) cash bonus.
• 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:
• No

EEO Statement

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.