Operational Quality Assurance Specialist

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 Operational QA Manager role could be an ideal opportunity to explore.

This position is responsible for the deviation management and change control processes at the site and supports all functional areas that assess, investigate, write, manage, and approve deviations and change control projects. They assist in root cause analysis, problem solving, mentoring, corrective and preventative action development, and coaching of Excellence in Deviation Management (eDM) principles of investigation. They drive change through assessment of proposed change projects, provide guidance for compliance, and lead the local change panel.  They interface routinely with the Batch Release team to meet scheduled release targets. The purpose of this role is to drive performance and compliance in investigations by increasing early detection and preventing quality issues in addition to performance and compliance in change management. In doing so, they will achieve transformational reduction of total and repeat deviation, timeline compliance and target deliverable release dates, and site operational change improvement.

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

• Drive adherence to local and corporate procedures for Deviation, CAPA, and Change Control
• Champion, train, coach, and facilitate application of eDM tools (Rapid Response, 5W+1H, Gap Analyses, Fishbone, RCA, 5-Why, Line of Site, SMART-AR, Solution Specification)
• Liaise with internal/external experts and peers to share and adopt best practices
• Maintain the site maturity matrix and drive continuous improvement for eDM
• Work with departments to time-manage site deliverables and track performance/compliance metrics
• Support CAPA creation and assessment; Support Change Control creation and assessment
• Promote and exercise GEMBA and walk through of areas and processes to drive improvement and RCA; utilize GPS as an advocate for change
• Monitor Trackwise or applicable computerized system, for assigned activities related to batch release; provide trending of issues, deviation metrics, and quality culture
• Assist with audits, investigations, projects as requested
• Assist with data support and batch disposition through SAP or applicable computerized system
• Comply with and support the GSK Environmental, Health and Safety policies and procedures.

Why you?

Basic Qualifications:

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

• Associate degree
• Experience in a regulated Pharmaceutical, Consumer Healthcare, and/or health care related industry.
• Experience in investigational writing, problem solving and other duties within the Quality organization.
• Experience addressing technical business solutions, assuring compliance with regulations

Preferred Qualifications:

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

• Bachelor’s degree
• Expert knowledge of computer systems especially Microsoft Excel, Word, TrackWise, and SAP (preferred)
• Strong communications and interpersonal skills
• Presence and approachability; proactive engagement of personnel

Why GSK?

Our values and expectations are at the heart of everything we do and form an important part of our culture.

These include Patient focus, Transparency, Respect, Integrity along with Courage, Accountability, Development, and Teamwork. As GSK focuses on our values and expectations and a culture of innovation, performance, and trust, the successful candidate will demonstrate the following capabilities:

• Operating at pace and agile decision-making – using evidence and applying judgement to balance pace, rigour and risk.
• Committed to delivering high quality results, overcoming challenges, focusing on what matters, execution.
• Continuously looking for opportunities to learn, build skills and share learning.
• Sustaining energy and well-being.
• Building strong relationships and collaboration, honest and open conversations.
• Budgeting and cost-consciousness.

*This is a job description to aide in the job posting, but does not include all job evaluation details.

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.

Important notice to Employment businesses/ Agencies

GSK does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact GSK's commercial and general procurement/human resources department to obtain prior written authorization before referring any candidates to GSK. The obtaining of prior written authorization is a condition precedent to any agreement (verbal or written) between the employment business/ agency and GSK. In the absence of such written authorization being obtained any actions undertaken by the employment business/agency shall be deemed to have been performed without the consent or contractual agreement of GSK. GSK shall therefore not be liable for any fees arising from such actions or any fees arising from any referrals by employment businesses/agencies in respect of the vacancies posted on this site.

Please note that if you are a US Licensed Healthcare Professional or Healthcare Professional as defined by the laws of the state issuing your license, GSK may be required to capture and report expenses GSK incurs, on your behalf, in the event you are afforded an interview for employment. This capture of applicable transfers of value is necessary to ensure GSK’s compliance to all federal and state US Transparency requirements. For more information, please visit GSK’s Transparency Reporting For the Record site.