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QC Scientist

ProClinical Zebulon Full-Time
Highly Competitive Salary
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Proclinical is currently recruiting for a QC Scientist for a pharmaceutical company located in Zebulon, NC. Successful candidate will conduct routine microbiological testing of raw materials, packaging materials, finished products and environmental samples using approved methods, and established policy and various instrumentation while adhering to cGMP and established policy.

Job Responsibilities:

  • Coordinate and participate in site projects, analytical/microbiological method development, validation, revision and transfer, and keep immediate supervisor informed of important aspects of projects and assignments.
  • Design and perform experiments to develop, validate, revise and transfer new analytical/microbiological methods including automated and robotic methods.
  • Provide technical support and leadership as pertains to analytical/microbiological testing; verify that results are accurate and complete, recognizing deviations in test procedures, and/or SOPs.
  • Appropriately document QCl data and investigations. Write laboratory documents such as technical reports, analytical/microbiological test methods, specifications, SOPs validation documents, and transfer documents.
  • Train analysts in operation of equipment, GSKs analytical/test methodology, computer applications and safety procedures. Review and revise training materials. Identify training needs within staff.
  • Provide technical support to group members, including integration techniques and calculations. Use technical expertise and skills to independently solve problems, including method and instrument troubleshooting.
  • Release analytical data from the laboratory for purposes such as manufacturing, product release to the commercial market. Demonstrate proficiency on most test methods within QC.
  • Provide technical support and leadership as pertains to Perform microbiological testing; verify that results are accurate and complete, recognizing deviations in test procedures, and/or SOP's.

Skills and Requirements:

  • BS or equivalent experience.
  • Developing knowledge and application of the Quality Management System (QMS) 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.
  • 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.
  • Capability to assist with installation and validation of analytical equipment.
  • Capability to assist with validation and transfer test methods as applicable.
  • Technical expertise in a broad range of microbiological methodologies from microbial challenges, identification and understands training methods and practices to ensure that staff are trained to employ these techniques to a high standard.

To Apply:

Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.

In case you have difficulty in applying or if you have any questions, please call Sarah Beshara at (+1) Phone number blocked - click to apply or upload your resume on our website - www.proclinical.com.

A full job description is available on request.

Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

Proclinical Staffing is an equal opportunity employer.

#LI-SB4
#Scientific

BS or equivalent experience. Developing knowledge and application of the Quality Management System (QMS) 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. 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. Capability to assist with installation and validation of analytical equipment. Capability to assist with validation and transfer test methods as applicable. Technical expertise in a broad range of microbiological methodologies from microbial challenges, identification and understands training methods and practices to ensure that staff are trained to employ these techniques to a high standard.

Recommended skills

Product Quality Assurance
Quality Management Systems
Installations (Computer Systems)
Good Manufacturing Practices
Methodologies
Microbiology
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Job ID: SC.SB.24902

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ProClinical is a leading international life sciences recruitment company with a proven track record of having filled thousands of permanent and contract vacancies at pharma, biotech and medical device companies, contract research organisations (CROs) and other life sciences companies in Europe, Asia and the USA.

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