Senior Scientist QC

GlaxoSmithKline • Zebulon, NC

258d

About The Position

Are you interested in working with cutting-edge laboratory technology to improve quality and accelerate regulatory compliance? If so, this Senior Scientist QC role could be an exciting opportunity to explore. As a Senior Scientist QC, you will ensure that the QC testing of all products is performed to GMP and company standards. This involves analytical Chemistry testing in a Pharmaceutical Respiratory laboratory, 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.

Requirements

• Bachelor's degree in chemistry or other scientific degree and 5+ years' relevant pharmaceutical experience or Master's degree and 2+ years' pharmaceutical experience.
• Experience of providing QC testing support to at least one value stream.

Nice To Haves

• Knowledge/experience with internal and external audits (cGMP and FDA).
• Ability to lead and encourage continuous improvement.
• Operational knowledge of laboratory equipment, including ability to diagnose problems and identify appropriate actions e.g. HPLC, GC, UV or FTIR Spectrometers.
• Full understanding of the requirements and application of GMP principles in a laboratory environment.
• Knowledge/experience in performing user acceptance testing for LIMS systems.
• Effective verbal and written communication on an individual and group basis targeted to appropriately audiences of several levels within GMS.
• Understanding of installation and validation of analytical equipment.
• Understanding of validation and transfer of 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.
• Developing knowledge and application of the Quality Management System (QMS).
• Demonstrated ability to participate in product projects - command of ICH guidance (ICHQ), GMP requirements and FDA/EMEA regulations.
• Develop/design lab studies and protocols to be acceptable to regulators, as applicable.
• Good understanding of products, data and statistical tools, to be able to discuss and understand the state of the laboratory in relation to the business metrics.

Responsibilities

• Provide technical support and leadership pertaining to analytical testing.
• Verify that results are accurate and complete.
• Recognize deviations in analytical test procedures and SOP's.
• Evaluate product trends and perform analytical testing when necessary.
• Coordinate and direct the use of laboratory resources to meet manufacturing/packaging schedules, distribution and market requirements, stability commitments, and validation/process engineering initiatives.
• Assess the training needs of the staff to coordinate training as necessary.
• Release (approve/reject) analytical data from the laboratory for purposes such as manufacturing, product release to the commercial market, and stability reporting.
• Serve as a site representative for specialized technology in interdepartmental and international project teams (e.g., new product development, CAPs, USP).
• Review and provide input into the development of analytical methods, specifications, testing protocols, SOPs, and regulatory documents (NDAs, sNDAs, MAAs, etc.).
• Ensure compliance to regulated procedures.
• Troubleshoot methods and instrumentation.
• Participate/assist in laboratory investigations for out of specification or atypical results.
• Notify and participate with management and interdepartmental teams concerning expanded investigations (external to the laboratory).

Benefits

• Onsite cafeteria
• Onsite gym
• Temperature-controlled climate
• Licensed, onsite Health & Wellness clinic

What This Job Offers

• Career Level: Senior
• Industry: Chemical Manufacturing
• Education Level: Bachelor's degree