Quality Control Project Specialist - Marietta, United States - GSK

GSK

Verified Company

Marietta, United States

2 weeks ago

Posted by:

Mark Lane

beBee recruiter

Description

Site Name:
USA - Pennsylvania - Marietta

Posted Date:
Apr

Are you looking to enhance your technical capability by working in a global manufacturing environment that allows you to leverage best in class systems and technologies? If so, this Quality Control Project Specialist role could be an ideal opportunity to explore.

The Quality Control Project Specialist will manage the successful lifecycle of QC projects and programs in accordance with timelines, budgets, scope and quality standards.

The QC Project Specialist will be responsible for the complete lifecycle management of QC projects as well as the following:

Define and determine project scope (In-and out-of-scope), responsibilities, and stakeholders.
Demonstrated familiarity and compliance with cGMP's, EHS procedures and regulations, facility regulatory guidelines, and standard operating procedures.
Decide project resource requirements and resourcing strategy for project to be completed.
Influence key stakeholders for embedded local resources.
Establish team roles and responsibilities and time commitments for all team members

(Examples include:

automation, validation, EHS, procurement, etc.)

Manage project finances, contracts and vendors in accordance with budget and ensure adherence to government reporting requirements.
Develop detailed project schedules, including but not limited to activities such as; vendor selection and management, material provisioning, master data changes, QC test method transfer/validation, IQ/OQ/PQs, validation of equipment, protocols/reports/VMP, Automation updates, LSOP creation/revision, Change Control, engineering runs, and handover/training local operational team
Execute project according to plan and maintain critical path.
Monitor and communicate progress and ensure project outcomes meet project objectives.
Proactively identify project risk areas or production impact and recommend appropriate mitigation or contingencies.

_ Why you?_:

Basic Qualifications:

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

Bachelor's degree
Minimum of 1 year of experience in cGMPregulated laboratory environment.

Preferred Qualifications:

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

Previous experience in project management a plus.
Working knowledge of pharmaceutical facilities and processes.
The ability to communicate both verbally and in writing with all levels both inside and outside of the organization.
The ability to clearly write technical documentation as necessitated by regulatory agencies and internal policy.
Ability to establish and maintain working relationships with staff and the ability to analyze data and implement changes.
Must be able to address complex problems associated with assessing deviations, determination of root cause, and implementation of change and improvement to validated and/or FDA approved production systems.
Must have an aptitude for facilitating a team environment and working independently toward the goal of completing product investigations.
Participate in crossfunctional department needs, as required.
Must have strong organizational skills

LI-GSK

MariettaGSC

Please visit GSK US Benefits Summary to learn more about the comprehensive benefits program GSK offers US employees.

Why Us?

GSK is a global biopharma company with a special purpose - to unite science, technology and talent to get ahead of disease together - so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns - as an organization where people can thrive.

Getting ahead means preventing disease as well as treating it, and we aim to positively impact the health of 2.5 billion people by the end of 2030.

Our success absolutely depends on our people.

While getting ahead of disease together is about our ambition for patients and shareholders, it's also about making GSK a place where people can thrive.

We want GSK to be a workplace where everyone can feel a sense of belonging and thrive as set out in our Equal and Inclusive Treatment of Employees policy.

We're committed to being more proactive at all levels so that our workforce reflects the communities we work and hire in, and our GSK leadership reflects our GSK workforce.

GSK is an Equal Opportunity Employer and, in the US, we adhere to Affirmative Action principles.

This ensures that all qualified applicants will receive equal consideration for employment without regard to race, color, national origin, religion, sex, pregnancy, marital status, sexual orientation, gender identity/expression, age, disability, genetic information, military service, covered/protected veteran status or any other federal, state or local protected class.

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