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Job Information

Cogent Infotech Scientist I in St. Louis, Missouri

Job Description

Hours: 8A - 5P

Location/Division Specific Information

This position supports the QC Analytical team for our Biologics Division in St. Louis, MO.

How will you make an impact?

The Scientist I(QC Analytical )will be responsible for Quality Control in support of Commercial and Clinical Biopharmaceutical Manufacturing. He/She will be responsible for following Current Good Manufacturing Practices (cGMP) and carrying out a variety of functions related to Quality Control methods, scheduling, deviations and CAPAs. Functions may include, but are not limited to: Managing QC needs for clients and the preparation and revision of documents per ICH guidelines for Biopharmaceutical Drug Substance (such as product specifications, validation protocols and reports).

What will you do?

  • Work directly with client site QC Leads to direct assess and direct work related to the Quality Control team.

  • Data location and upload to client specific folders

  • Liaise between internal and client teams to drive QC projects and process solutions.

  • Carries out duties in compliance with all local, state and federal regulations and guidelines including FDA, EPA, and OSHA.

  • Complies with all company and site policies and procedures. Reports any non-conformances. Initiates and/or leads resolution efforts and laboratory investigations.

Education

  • Bachelor's Degree in a Biological Science related field

Experience

  • 5+ years related experience in biopharmaceutical or pharmaceutical industry.

  • Experience with authoring documents for qualification/validation of QC assays.

Knowledge, Skills, Abilities

  • Extensive knowledge of GMP regulations in a cGMP manufacturing environment.

  • Working knowledge of scientific principles for a wide range of analytical techniques strongly preferred.

  • Routine use of MS Excel, MS PowerPoint, and MS Word is essential

  • Ability to understand customer requirements related to Quality control, including processes and equipment.

  • Outstanding technical writing skills.

  • Strong interpersonal skills including actively listening, conflict resolution and the ability to effectively influence diverse stakeholders for positive outcome.

  • Ability to build strong relationships with client while instilling trust and confidence

  • Highly organized with attention to detail

  • Familiar with standard project management concepts, tools and responsibilities (objectives, scope, deliverables)

  • Knowledge of Qualification and Validation requirements for analytical methods

  • Ability to manage client needs related to QC scheduling and visits in support of site departments (Program Management, Operations, QA

  • Strong organizational skills in monitoring QC qualification, validation and release activities in progress

  • Excellent communication skills - Coordinate and communicate with Program Managers for project related needs and issues

Working knowledge of cGMPs and Quality Control regulatory requirements

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