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26 days old

Senior GMP Quality Specialist (Dayton, NJ)

Kelly Services
Dayton, NJ 08810
**Senior GMP Quality Specialist (Dayton, NJ)**


**Pay: $68.00-$69.00/Hour**


**Full-Time Contract Position**


**The Senior Quality Specialist Job Description:**


+ Responsible and accountable for quality tasks and provides guidance on operational activities. He/She will lead the development of a GMP program in the lab.

+ This individual must possess broad knowledge of Quality principles, practices, and procedures. This person will also be involved in the Change Control process, Corrective and Preventive Action (CAPA) system, nonconforming material process, supplier qualification process, internal audit process and third-party audit process. Leads cross-functional teams and track projects to completion.

+ Requires experience in cGMP and GLP environments plus demonstrated familiarity with standard quality concepts, practices, and procedures.


The responsibilities of a Senior GMP Quality Specialist includes, but is not limited to:


+ Lead the cGMP program development

+ Coordinate and perform auditing of suppliers.

+ Manage supplier qualification process ensuring procedures are executed accordingly and all suppliers are approved prior to purchasing from them.

+ Coordination and resolution of supplier quality issues. Includes investigation, resolution, follow-up and corrective actions.

+ Coordinate and approve client and/or supplier quality agreements.

+ Proactively initiate the development of streamlined systems to effectively identify and resolve quality problems and process improvement opportunities.

+ Act as the Audit Leader and coordinate internal audits and inspections of various departments/processes.

+ Able to identify cGMP gaps and work with process owners to resolve.

+ Coordinate CAPA program by managing priorities and overcoming obstacles. Provide support on root cause analysis and development of corrective and preventive actions.

+ Develop and improve content for cGMP site-wide training.

+ Write, revise, and review SOPs, controlled forms and related documents as needed to ensure best practices and current operations. Review and approve documents through the change control process.


Qualifications:


Experience and/or Education:


o Bachelors degree required


o 8 years related experience required:


Experience in a FDA regulated environment: Pharmaceutical and Medical Devices.


Knowledge of GLP requirements for a laboratory.


Experience in training, investigations, root cause analysis, Corrective Action Preventive Action (CAPA), auditing (internal and suppliers), leading process improvement, customer complaints, leading regulatory audits, and product quality reviews


**You should know:** Your safety matters! Vaccination against COVID-19 may be a requirement for this job in compliance with current client and governmental policies. A Kelly recruiter will confirm and share more details with you during the interview process.


**Why Kelly** **** **?**


Kelly Science & Clinical is your connection to premier scientific and clinical companies looking to hire talented people just like you. Every day, we match science professionals with dream jobs that fit their skills and interestsits the way we think job searching should be. Nearly 100 percent of our science recruiters have a professional background/education in science, so we know a thing or two about the science market and how to get you noticed.


**About Kelly** ****


At Kelly, were always thinking about whats next and advising job seekers on new ways of working to reach their full potential. In fact, were a leading advocate for temporary/nontraditional workstyles, because we believe they allow flexibility and tremendous growth opportunities that enable a better way to work and live (plus, did we mention we provide a ton of benefits ?). Connecting great people with great companies is what we do best, and our employment opportunities span a wide variety of workstyles, skill levels, and industries around the world.


Kelly is an equal opportunity employer committed to employing a diverse workforce, including, but not limited to, minorities, females, individuals with disabilities, protected veterans, sexual orientation, gender identity. Equal Employment Opportunity is The Law. (https://www.dol.gov/ofccp/regs/compliance/posters/ofccpost.htm)
Posted: 2022-04-25 Expires: 2022-05-26

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Senior GMP Quality Specialist (Dayton, NJ)

Kelly Services
Dayton, NJ 08810

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