QC Scientist Job

QC SCIENTIST needed for a CONTRACT opportunity with Yoh's client located in Rockville, MD.

THE BIG PICTURE - TOP SKILLS SHOULD YOU POSSESS:

- HPLC
- ELISA
- qPCR
- cGMP environment

WHAT YOU'LL BE DOING:

- To ensure that the QC testing of all products is performed to GMP and company standards.
- This involves analytical/microbiological testing (as applicable), analysing samples, recording, evaluating and reporting data using prescribed procedures with limited or no supervision.
- Conduct routine analytical testing of finished and in-process protein drug products using approved methods, and established policy and various instrumentation (eg, HPLC, CGE, GC, UV, ELISA, qPCR) while adhering to cGMP and established policy.
- Coordinate and participate in site projects, analytical method development, validation, revision and transfer, and keep immediate supervisor informed of all important aspects of projects and assignments.
- Design and perform experiments to develop, validate, revise and transfer new analytical methods.
- Provide technical support and leadership as pertains to analytical testing; verify that results are accurate and complete, recognizing deviations in test procedures, and/or SOP's. Appropriately document data and investigations.
- Write laboratory documents such as technical reports, analytical test methods, specifications, SOP's validation documents, and transfer documents.
- Train analysts in operation of equipment, analytical/test methodology, computer applications and safety procedures. Review and revise training materials. Identify training needs within staff.
- Participate in evaluation and selection of new instrumentation and assist with implementation.
- 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 (approve/reject) analytical data from the laboratory for purposes such as manufacturing, product release to the commercial market.

WHAT YOU NEED TO BRING TO THE TABLE:

- Sc. Degree in Chemistry/Biology or related science or equivalent experience
- Technical expertise in a broad range of analytical methodologies from core HPLC techniques, sample preparation techniques spectroscopy, residuals testing etc and understands training methods and practices to ensure that staff are trained to employ these techniques to a high standard (as applicable).
- Experience of providing QC testing support to at least one value stream.
- 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.
- Understanding GMP principles in a laboratory environment.
- Ensuring stability protocols are designed to be acceptable to regulators, maximize 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.
- Capability to assist with installation and validation of analytical equipment.
- Capability to assist with validation and transfer test methods as applicable.
- 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.
- 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.

OPPORTUNITY IS CALLING, APPLY NOW!

RECRUITER:Hannah Cihlar

Yoh, a Day & Zimmermann company, is an Equal Opportunity Employer, M/F/D/V.

J2W: HC, CLINICAL, MONJOB

TAXTERM: CON_W2J2WMIDATL

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SFSF: LS