Are you looking for a position as a Compliance Specialist? The Compliance Specialist position exists to extend the scope and effectiveness of the compliance program. The Compliance Specialist will support the organization in increased alignment with the GSK Quality Management System and cGMP at Zebulon.

As a Compliance Specialist, you will be responsible for extending the scope and effectiveness of site operational programs.

This role will fully support the Production Department regarding operational compliance in the following areas:

• Audits (including Self-Inspections): Specialist will be responsible for establishing the L1 audit universe and supporting the capability build (development and training) of the value stream in conducting and reviewing L1 audits. Specialist will also lead take the lead, where appropriate, on CAPAs originating from L2-L4 audits.

• Effective Deviation Management/Investigations: Specialist will support and lead selected root cause analysis investigations ensuring that effective problem-solving tools/templates are used, and appropriate Corrective and Preventive Actions are identified.

• Risk Management: Specialist will facilitate (and document) the monthly functional area risk management review and support the capability build (development/training) of the value stream in proactively managing risk mitigation. 

• Documentation (SOPs, CPFs, Forms, Logbooks, OJTs, etc.): Specialist will lead document updates (author, solicit input from operational team and supporting partners, and route for approval).

• Training: Specialist will support training, as necessary, on changes associated with production processes (batch document and procedural changes).

Why you?

Basic Qualifications:

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

• Bachelor’s degree in business or Scientific Discipline Experience in cGMP environment

• 3 years of experience in (Clinical Good Manufacturing Practices) cGMP environment

• Experience in a Compliance role authoring and/or revising technical documents (SOPs, Work Instructions, Forms).

• Proficient in Microsoft Office Suite.

Preferred Qualifications:

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

• Bachelor's of Science degree preferred.

• Experience assessing individual and team performance.

• Auditing experience preferred.

• Excellent presentation and facilitation skills

• Strong problem solving/root cause analysis, reasoning skills, interpersonal and organizational skills.

• Strong interpersonal, and excellent written and oral communication skills

• Ability to Comply with all local, state, federal laws and regulations.

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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, Wilson, 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 climate                                  

* Licensed, onsite Health & Wellness clinic 

Why GSK?

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 impact the health of 2.5 billion people around the world in the next 10 years.

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 place where people feel inspired, encouraged and challenged to be the best they can be. A place where they can be themselves – feeling welcome, valued and included. Where they can keep growing and look after their wellbeing. So, if you share our ambition, join us at this exciting moment in our journey to get Ahead Together.

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.

If you require an accommodation or other assistance to apply for a job at GSK, please contact the GSK Service Centre at 1-877-694-7547 (US Toll Free) or 1 801 567 5155 (outside US).

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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