QC Analyst I
Location:
Posted:
October 27, 2016
Reference:
WD94429
Basic qualifications:
Associate's Degree in Science or Relevant Field
2+ years experience in an FDA regulated environment

Preferred qualifications:
Bachelor's Degree in Science or Relevant Field.
Pharmaceutical quality experience preferred.
Knowledge of general cGMP requirements.
Demonstrates attention to detail and organizational skills.
Excellent communication and interpersonal skills (oral and written).
Ability to maintain good housekeeping, order, and safety in workplace.

Details:
GSK is a science-led healthcare company. Our mission is to improve the quality of human life by enabling people to do more, feel better and live longer. As the world's largest manufacturer of over-the-counter products, reaching more than 1 billion consumers, GSK's Consumer Healthcare business is on an exciting journey. We're passionate about building the world's best fast-moving consumer healthcare company with a focus on quality, backed by science.

Preventing and treating disease is challenging and inspiring work. At GSK, we support, develop and reward the people who make up our talented workforce. Our Consumer Healthcare facility in Lincoln, Neb., proudly manufactures household names such as Theraflu, Excedrin, Benefiber and Prevacid. We're proud of our heritage and success in the Lincoln area ... and our impact on patients' lives around the world.

The Quality Control Analyst I develops knowledge
of functional area policies and procedures, and performs routine analytical testing functions in at least one QC laboratory. Develops an understanding of applicable Quality System modules, cGMP requirements, laboratory processes and procedures, and other regulatory authority requirements. Develops operational proficiency using analytical techniques and instrumentation to support testing for applicable products and raw materials. Contributes to projects as assigned and participates in continuous improvement efforts. Understands established internal and external customer expectations and maintains effective communication pathways.

General Responsibilities:

Develops a working knowledge of applicable departmental policies and procedures.
Performs routine analytical testing in cGMP laboratory environment according to written procedures and test methods.
Develops thorough knowledge as a data checker and reviewer accountability.
Develops a thorough knowledge of regulations and requirements of applicable cGMP's, Quality System modules, FDA Guidance Documents, and other regulatory authority requirements.
Maintains effective communication processes with key customers and project managers and provides periodic project progress reports.
Works independently and/or in a team environment to meet or exceed established objectives, applicable Key Performance Indicators (KPI's) and Quality Performance Indicators (QPI's).

Functional Area Responsibilities:

Analytical Chemistry Product Testing Laboratory
• Develops operational proficiency for analytical test methods for finished product and intermediates.
• Develops proficiency using analytical chemistry wet methods and instrumentation according to the defined training program.

Analytical Chemistry Raw Materials Laboratory
• Develops operational proficiency for analytical test methods for raw materials.
• Develops proficiency using analytical chemistry wet methods and instrumentation according to the defined training program.
• Develops a clear understanding of USP compendia, and proprietary test methodology.

Analytical Technical Services Laboratory
• Develops operational proficiency for analytical test methods for raw materials, finished product and intermediates.
• Develops proficiency using analytical chemistry wet methods and instrumentation according to the defined training program.

Microbiology Laboratory
• Develops operational proficiency for microbiological test methods for raw materials, finished product and intermediates.
• Develops proficiency using microbiological methods and instrumentation according to the defined training program.

Laboratory Support/Sample Administration
• Develops operational proficiency for physical test methods for finished product and intermediates.
• Develops operational proficiency for managing the flow of raw materials, finished product and intermediates from the point of origin to the testing teams.
• Develops operational proficiency for managing the physical inventory of raw materials, finished product and intermediates as required by departmental policies and procedures.

Laboratory Support/Laboratory Trainer
• Develops thorough knowledge of laboratory training plans.
• Provides basic GMP and orientation training for new associates.
• Develops proficiency in managing the training of new associates for the testing teams.

Contact information:

You may apply for this position online by selecting the Apply now button.
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GSK is an Equal Opportunity/Affirmative Action Employer. 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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A little about us:
We are a science-led global healthcare company on a mission to help people to do more, feel better and live longer.

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