The Associate QC Scientist will ensure that the QC testing of all products is performed to GMP and company standards. This involves analytical/microbiological testing (as applicable), analyzing samples, recording, evaluating and reporting data using prescribed procedures with limited or no supervision.

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

• Conduct routine analytical testing of raw materials, packaging materials, finished products and environmental samples using approved methods and various instrumentation, (e.g., HPLC, Vitek, GC, UV, Microscope, Gram Stainer, and Robotics) while adhering to cGMP and established policy.
• Generate valid data at expected levels of productivity while adhering to cGMP.
• Interpret validity of own test data and generate accurate results.
• Advise immediate supervisor or designee of all important aspects of analytical testing including deviations.
• Accurately document analytical data and review official laboratory documents (e.g., SOP’s, Technical reports, Methods, and specifications).
• Maintain and troubleshoot laboratory instruments.
• Maintain appropriate documentation of training activities and conduct training of laboratory personnel on methods, instrumentation, and computer systems
• Participate in interdepartmental project teams or committees.
• Assist in analytical method development, validation, revision and transfer including automated methods.
• Provide technical support by executing protocols, and evaluation results for non-routine testing

Why you?

Basic Qualifications:

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

• Bachelor’s Degree or equivalent OR Associates Degree w/ 2 years of pharmaceutical experience OR High School Diploma w/ 4 years of pharmaceutical experience.
• Experience of providing QC testing support to at least one value stream. • Developing knowledge and application of the Quality Management System (QMS)

Preferred Qualifications:

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

• Knowledge of company products and quality impact as it relates to those products.
• Demonstrated ability to participate in product projects - command of ICH guidance (ICHQ), GMP requirements and FDA/EMEA regulations. Ensuring stability protocols are designed to be acceptable to regulators, maximise data generation and also utilize resources as efficiently as possible.
• Understanding of products, data and statistical tools to enable the construction of through life specifications and shelf-life specifications • Experience of working in teams to improve processes or resolve problems using OE tools.
• Operational knowledge of analytical chemistry/microbiology (as applicable), complex laboratory equipment, including ability to diagnose problems and identify appropriate actions.
• Full understanding of the requirements and application of GMP principles in a laboratory environment.
• Effective verbal and written communication on an individual and group basis targeted to appropriately audiences of several levels within GMS.
• Assist/participate in the installation and validation analytical equipment.
• Assist/participate in validation and transfer test methods.
• Developing leadership skills with an ability to form strong win/win partnerships. A demonstrated willingness to collaborate with colleagues to share best practices and /exchange ideas. Supports other teams when required.
• Technical expertise in a broad range of analytical methodologies from core HPLC techniques, sample preparation techniques (including automation) spectroscopy, dissolution testing, physical testing, hardness etc. and understands training methods and practices to ensure that staff are trained to employ these techniques to a high standard (as applicable).
• Technical expertise in a broad range of microbiological methodologies from microbial challenges, identification, sample preparation techniques, facility monitoring/response etc and understands training methods and practices to ensure that staff are trained to employ these techniques to a high standard (as applicable).

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.

At GSK, the health and safety of our employees are of paramount importance. As a science-led healthcare company on a mission to get ahead of disease together, we believe that supporting vaccination against COVID-19 is the single best thing we can do in the US to ensure the health and safety of our employees, complementary workers, workplaces, customers, consumers, communities, and the patients we serve. 

GSK has made the decision to require all US employees to be fully vaccinated against COVID-19, where allowed by state or local law and where vaccine supply is readily available. The only exceptions to this requirement are employees who are approved for an accommodation for religious, medical or disability-related reasons.

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