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Records Review Associate 1st Shift

2 months ago

Raynham, United States Kelly Services Full time

Kelly Science and Clinical FSP is currently seeking a Records Review Associate 1st shift or a long-term engagement with one of our Global Pharmaceutical/Medical Device clients.  This position is onsite in Raynham, MA and pays 22/HR. This person will join our Kelly FSP (Functional Service Provider) division, a managed solution provider and business unit of Kelly Services, Inc. This role is full-time and is offering full benefit options. As a Kelly FSP employee you may be eligible for Medical, Dental, Vision, 401K and a variety of other benefits to choose from. You may also be eligible for paid time off, including holiday, vacation, and sick/personal time.

Responsibilities:
Responsible for ensuring company products comply with internal and external specifications by performing a variety of routine and non-routine inspections and evaluations. This includes activities related to Inspection and Testing, Batch Release and Records Management.

Position Duties And Responsibilities 3rd Shift:
Batch Release and Records Management

Audits batch records to ensure compliance with policies, procedures and regulations.

Ensures batch records are complete and accurate, with all NC’s dispositioned prior to release.

Identifies, records and reports on batch non- conformances and product holds.

Stores and maintains batch files either physically or electronically based on established guidelines.

General Responsibilities
Applies principles of Good Documentation Practices.

Executes assigned NR actions within the applicable software application.

Provides metrics and updates on executions.

Maintains training records up-to-date.

Use of computer-based applications to manage:


Inventories,
Batch records
Down time
Communication
Inspection equipment
Inventory equipment


Education: High School/Secondary Education or Equivalent.


Requires (1 year +) years related experience.

Interpersonal skills / characteristics:


Quality-oriented mindset
Flexibility
Team environment; collaboration
Service Oriented


 



 




As part of our promise to talent, Kelly supports those who work with us through a variety of benefits, perks, and work-related resources. Kelly offers eligible employees voluntary benefit plans including medical, dental, vision, telemedicine, term life, whole life, accident insurance, critical illness, a legal plan, and short-term disability. As a Kelly employee, you will have access to a retirement savings plan, service bonus and holiday pay plans (earn up to eight paid holidays per benefit year), and a transit spending account. In addition, employees are entitled to earn paid sick leave under the applicable state or local plan. Click here for more information on benefits and perks that may be available to you as a member of the Kelly Talent Community.Why Kelly® Science & Clinical? Kelly Science & Clinical is your connection to premier scientific and clinical companies looking to hire industry experts just like you. Our team creates expert talent solutions to solve the world’s most critical challenges. Every day, we match science professionals with dream jobs that fit their skills, interests, and career goals—it’s the way we think job searching should be. Nearly 100 percent of our science recruiters have a professional background and education in science, so we know a thing or two about the science market and how to get your expertise noticed.






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