Job DescriptionThe QC Analyst III position supports the Quality Control group. The role requires knowledge and understanding of scientific concepts, practices and procedures within the biopharmaceutical field and a cGMP environment. The role is responsible for daily routine testing and laboratory maintenance tasks such as Environmental Monitoring of the GMP area, and sampling and testing of water, compressed air, nitrogen and bioburden testing samples. Individuals should be able to work independently and participate in cross functional teams for Operation Excellence, Root Cause analysis, and risk assessments. In this role, Individuals will use soft skills, to work on QC schedules and to work with internal customers (EHS, Manufacturing and QA)Role and Responsibilities:
- Assist the Manager, QC Micro / Analytical with feasibility assessment of client projects
- Perform microbiological / analytical work per method transfer/ validation programs.
- Perform environmental monitoring and utility testing of the facility.
- Inform supervisor/manager upon observing OOS, OOL, or generation of deviations.
- Participate in investigations of OOS results and other related studies.
- Write, review, and revise SOP's and Testing Standards as necessary.
- Train additional employees in methods transfers and techniques
- Review, analyze, interpret, and report data.
- Resource for technical knowledge of current assays
- Apply analytical knowledge to support change and risk management
- Review record keeping and documentation of laboratory equipment maintenance.
- Support department compliance and productivity goals.
- May require work on weekends and nights, travel, or work with 3rd party vendors.
- Able to complete required tasks and associated documentation with minimal error.
- Maintain a positive attitude in a changing work environment.
- Effectively communicate with all levels of manufacturing and support staff.
Background and Experience:
- Escalates issues through the proper channels.
- BS in Microbiology/Biology or related field
- 3-5 years in Pharmaceutical or Biotechnology with emphasis in aseptic processing, QC microbiology, environmental monitoring, water system, quality control, validation and manufacturing processes. .
- Track record of achievement and sustained performance in a cGMP/GLP environment.
- Strong technical and communication skills: oral/written and listening.
- Creative and Flexible
- Knowledge of MS Word, Excel and PowerPoint.
Company DescriptionHere at Medix, we are dedicated to providing workforce solutions to clients throughout multiple industries. We have been named among the Best and Brightest Companies to Work For in the Nation for two consecutive years. Medix has also been ranked as one of the fastest growing companies by Inc. Magazine.
Our commitment to our core purpose of positively impacting 20,000 lives affects not only the way we interact with our clients and talent, but also with our co-workers! The goal is lofty, but it is made attainable through the hard work and dedication of our teams and their willingness to lock arms together. Are you ready to lock arms with us?