Job Description

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

9521547

Job Tags

Holiday work, Full time, Night shift, Day shift,

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