Sterling Engineering, Inc. https://cdn.haleymarketing.com/templates/63335/logos/square_logo.png https://www.sterling-engineering.com https://www.sterling-engineering.com USD 32.45 HOUR true
Piscataway, NJ 08854 US
2023-03-15 2023-04-29 Employment Type: Contract Job Category: Chemist/ Lab Job Number: NA3671186314 Compensation: 32.45
VISA SPONSORSHIP NOT AVAILABLE
The Quality Management System ( QMS ) Specialist is responsible for the maintenance of Kashiv’s Quality Management System. The role requires a thorough knowledge of laboratory practices, including testing and OOS investigations, and Quality Management Systems such as Deviations, CAPAs, and Change Controls. This person will be responsible for ensuring that quality control and manufacturing operations have appropriate QA oversight in terms of QMS System, including identification and management of Nonconformances, OOS Investigations, and Deviations. The Quality Management System ( QMS ) Specialist will be expected to drive continuous improvement initiatives and be capable of assessing and improving existing systems. The incumbent will be responsible for Quality Management System functions of Quality Assurance, including providing guidance in support of both late-stage clinical and commercial biosimilar and novel Biologic products, cGMP-compliant laboratories, and manufacturing operations.
The candidate needs to be highly motivated, well-organized, and detail-oriented Quality personnel who can work effectively in a fast-paced and multi-disciplinary environment.
Essential Duties & Responsibilities
- Oversee thorough, timely and compliant closure of Change controls, OOS investigations, Deviations and CAPAs. Review progress and mentor department owners throughout the process to ensure the investigational process is logical, scientific, clear and supported by evidence, and in compliance with company procedures.
- Develop, initiate, manage, and implement improvements to quality systems and processes.
- Ensure that all operations are compliant with cGMPs regulatory requirements.
- Write, review, and approve SOP system documents to ensure cGMP compliance, as required.
- Reviews and approves protocols and reports.
- Supports regulatory inspections as a quality compliance representative.
- Monitors effectiveness of Quality Systems, developing event metrics such as number and type of batch record errors, training deviations, etc., and trend analysis for management review, escalates issues and drives resolution.
- Ensure proper root-cause analysis and implement corrective and preventive actions.
- Planning and implementation of Quality Review Board meetings.
- Interface with all levels of technical team to resolve issues.
- Performs other functions as required or assigned
- Complies with all company policies and standards
- Bachelor (required) /master’s degree in Life Science or other related discipline.
- Minimum of 10 years of relevant experience in a pharmaceutical quality assurance/control environment.
- Minimum of 3 years in a direct supervisory role.
- Experience of GMP document review, Quality Management System maintenance.
- Understand the requirements and procedures related to document control and Quality Assurance.
- Experience working with electronic quality system, preferred experience with Veeva and Master control, Blue Mountain RAM
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.