Senior Batch Record Review Specialist (Sun-Th night shift)

Are you energized by a quality assurance role that allows you to accelerate compliance in a state-of-the-art manufacturing environment?  If so, this Senior Batch Record Review Specialist role could be an ideal opportunity to explore.

As a Senior Batch Record Review Specialist, you will be responsible for providing effective and efficient support to the Local Operating Country (LOC) Quality Manager to maintain effective Quality Management System (QMS) and perform LOC Quality Operation activities in compliance with GSK Policies, QMS and local regulations.

This role will provide YOU the opportunity to lead key activities to progress YOUR career, these responsibilities include some of the following:

• Primarily responsible for review, release, and second check of batch record documentation for compliance to cGMPs, SOPs and internal and regulatory requirements.
• Coordinates investigations associated with production deviations, as needed. Closes Planned Notifications, as needed.
• Assists with issues of NRFT for batch documents.
• Provides quality guidance to production operations, completes work order assessments, and completes atypical comments.
• Communicates effectively with team members, escalates issues to production and quality team/lead, and provides on-call support, as needed.
• Supports self-inspections, internal audits and regulatory inspections.
• Provides end user support for GMP related documentation corrections. Supports continuous improvement processes.
• Responsible for certificate creation (C of A, C of M, C of C) in alignment with market requirements (TTS / Quality Agreements) along with review and second check verification.
• Agree personal objectives from the quality strategy and develops oneself.

Why you?

Basic Qualifications:

We are looking for professionals with these required skills to achieve our goals:

• High School Diploma and 4+ years relevant experience in the pharmaceutical industry, with a production or quality background -or- associate degree with 2+ years relevant experience in the pharmaceutical industry -or- BS/BA degree with 2+ years relevant experience in the pharmaceutical industry.
• 1+ years' Experience with batch document review and supporting in inspections and audits.
• 3+ years' Experience working in a pharmaceutical environment with exposure to production processes and GMP principles related to Oral Solid Dose or Metered Dose Inhaler Manufacturing.

Preferred Qualifications:

If you have the following characteristics, it would be a plus:

• Demonstrated serious commitment to accuracy, integrity, and quality.
• Must be able to work independently but also be a strong team player.
• Entry level experience of MERP.
• To be able to identify, monitor and report documentation errors.
• To give advice to production staff, and others, on quality related issues and to promote GMP awareness by liaison with manufacturing and production staff.
• Knowledge of cGMP - FDA and other Regulatory requirements.
• Understanding of continuous improvement tools.
• Understanding of IT applications, i.e., MERP, Microsoft office, LIMS.
• Good communication skills.
• Good organizational skills.
• Knowledge of Pharmaceutical Processes

About the Zebulon Site

GSK’s Zebulon site is a global supplier of Respiratory and Solid Dose medicines to patients around the globe and the largest GSK Pharmaceutical secondary manufacturing site in North America.  The site is located less than 30 minutes from downtown Raleigh, Wendell, Knightdale, Rocky Mount and Wake Forest.

Key differentiators about GSK and Zebulon:

* Our commitment to inclusion and diversity – we see diversity as a critical advantage of ours

* Our focus on cultivating a positive work environment that cares for our employees

* Demonstrated opportunities for continued career growth driven by individual ambition

* Leaders that care about their teams and growth of both individuals and the company

* A priority focus on Safety and Quality

* Clean and GMP compliant work environment   

* Onsite cafeteria                                                 

* Onsite gym                                                           

* Temperature-controlled                                  

* Licensed onsite Health & Wellness clinic     

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