GSK is currently looking for an Associate QA Document Control Specialist in Rockville, MD. This position requires a thorough understanding of cGMP regulations and compendia requirements. The individual must demonstrate the ability to handle multiple priorities and interface with individuals from various departments. Must demonstrate strong interpersonal skills, ability to attention to detail, and to perform with minimal supervision.

Key Responsibilities:

• Provide support to projects pertaining to document control management systems.
• Provide administrative support to document control related activities e.g. document filing, binding, and retrieval.
• Manage and ensure the provision of administrative support to internal/ external customers to ensure that all documents are maintained in accordance to the records retention requirements
• Manage documentsin Veeva QualityDocs (VQD) or equivalent electronic Document Management System according to the relevant procedures and standards.
• Draft, compile, review and update appropriate policies and procedures relevant to documentation management and archival on site to comply with the regulatory requirements.
• Maintaining electronic and hardcopy Documentation through its' lifecycle according to the QMS and GRS.
• Maintaining electronic and hardcopy versions of GxP Documentation from retention to archive
• Responsible for archiving and destruction of all Site Batch documentation in accordance with regulatory, QMS and GRS requirements
• Ensure master copies of documents are held in secure storage, archived, retrievable and reviewed/destroyed according to GRRS and company processes and policies
• Issue notification of Document changes to site (e.g. new issues, withdrawals, version updates)

Why you?

Basic Qualifications:

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

• Associates Degree

• Minimum of 1 year of GMP experience

Preferred Qualifications:

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

• Proficient knowledge of Microsoft applications
• Appreciation of the products manufactured on site so that administration support can be achieved efficiently
• Knowledge of Microsoft Office software e.g. Word, Excel and PowerPoint
• Good communication skills
• People interaction skills
• Good Organization skills
• Experience in quality systems, including validation, documentation, compliance department preferred
• Knowledge and understanding of cGMPs. Follows established procedures.
• Strong QA background.
• Can look for improvements and/or provide solutions to a variety of problems of moderate scope and complexity.
• Works well with members within and outside of the group.
• Can influence the team positively by participating with others in group improvement activities.

Why GSK?

At GSK, we have already delivered unprecedented change over the past four years, improving R&D, becoming a leader in Consumer Healthcare, strengthening our leadership, and transforming our commercial execution. Now, we’re making the most significant changes we’ve made to our business in over 20 years. We’re on track to separate and create two new companies in 2022: New GSK with a leading portfolio of vaccines and specialty medicines as well as R&D based on immune system and genetics science; and a new world-leading consumer healthcare company of loved and trusted brands.

With new ambition comes new purpose. For New GSK, this is to unite science, talent, and technology to get ahead of disease together – all with the clear ambition of delivering human health impact; stronger and more sustainable shareholder returns; and as a new GSK where outstanding people thrive.

Getting ahead means preventing disease as well as treating it. How we do all this is through our people and our culture. A culture that is ambitious for patients – so we deliver what matters better and faster; accountable for impact – with clear ownership of goals and support to succeed; and where we do the right thing. So, if you’re ready to improve the lives of billions, join us at this exciting moment in our journey. Join our challenge to get Ahead Together.

• LI-GSK

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