Proclinical is advertising a vacancy for a QC Lab Tech position with a top 10 global pharmaceutical company that develops a broad range of products across a variety of therapy areas, including cardiovascular, oncology, and respiratory. This position will be based in the organization's Nebraska-based office on a full-time basis. The vacancy is an exciting opportunity to work with a company that specialises in providing extensive therapies across multiple ranges of the healthcare industry.
The QC Lab Tech will be responsible for ensuring that the QC testing of all products is performed to GMP and company standards. They will perform analytical/microbiological testing (as applicable), analyze samples, record, evaluate, and report data using prescribed procedures with limited or no supervision.
Job Responsibilities:
- Conducting routine analytical/microbiological testing of raw materials, packaging materials, finished products and environmental samples using approved methods, and established policy and various instrumentation (e.g., HPLC, Vitek, GC, UV, microscope, gram strainer, robotics) while adhering to cGMP and established policy.
- Coordinating and participating in site projects, analytical/microbiological method development, validation, revision and transfer, and keeping immediate supervisor informed of all-important aspects of projects and assignments.
- Designing and performing experiments to develop, validate, revise, and transfer new analytical/microbiological methods, including automated and robotic methods.
- Providing technical support and leaderships as pertains to analytical/microbiological testing; verifying that results are accurate and complete, recognising deviations in test procedures, and/or SOPs.
- Appropriately documenting QCI data and investigations.
- Writing laboratory documents such as technical reports, analytical/microbiological test methods, specifications, SOP validation documents, and transfer documents.
- Training analysts in operating equipment, analytical/test methodology, computer applications, and safety procedures.
- Reviewing and revising training materials. Identifying training needs within staff.
- Participating in the evaluation and selection of new instrumentation and assisting with implementation.
- Providing technical support to group members, including integration techniques and calculations.
- Using technical expertise and skills to independently solve problems, including method and instrument trouble-shooting.
- Releasing (approving/rejecting) analytical data from the laboratory for purposes such as manufacturing and product release to the commercial market.
- Demonstrating proficiency on most test methods within QC methods and practices to ensure that staff are training to employ these techniques to a high standard.
- Developing knowledge and applying the Quality Management System (QMS), along with knowledge of company products and quality impact as it relates to those products.
- Ensuring stability protocols are designed to be acceptable to regulators, maximise data generation, and utilize resources as efficiently as possible.
- Assisting with installation and validation of analytical equipment.
- Assisting with validation and transfer test methods as applicable.
Skills and Requirements:
- A B.Sc. Degree in Chemistry/Biology or a related physical science. Sufficient technical experience will be accepted.
- Demonstrable experience providing QC testing support to at least one value stream.
- Demonstrable ability to participate in product projects, along with a strong command of ICH guidance (ICHQ), GMP requirements, and FDA/EMEA regulations.
- A thorough understanding of products, data, and statistical tools to enable construction through life specifications and shelf-life specifications.
- Experience of working in teams to improve processes or resolve problems using OE tools.
- Thorough operational knowledge of analytical chemistry/microbiology (as applicable) and complex laboratory equipment, as well as the ability to diagnose problems and identify appropriate actions.
- A 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.
- 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.
- Technical expertise in a broad range of microbiological methodologies from microbial challenges, identification, sample preparation techniques, facility monitoring/response etc., as well as an understanding of training methods and practices to ensure that staff are trained to employ these techniques to a high standard (as applicable).
- An understanding of understands training methods and practices to ensure that staff are trained to employ these techniques to a high standard (as applicable).
- Demonstrable multitasking, project management, and execution skills.
- Good interpersonal skills, including communication, presentation, persuasion, and influence.
- Good organisational skills, including efficiency, punctuality, and collaboration in a team environment.
- Proficiency with computer skills, such as MS Office.
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 contact Sarah Beshara at +267-477-3355 or upload your CV 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.
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