Quality Control Analyst (Bioscience)

I. JOB SUMMARY

The QC Analyst II, position supports the Quality Control group at Rockville Campus. 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.

II. ESSENTIAL FUNCTIONS

Reasonable accommodations will be made to enable individuals with disabilities to perform the essential functions.

• Basic understanding of compliance/guidance/regulation pertaining to assigned are.
• Perform routine testing following written procedures and limited non-routine testing including validation studies with supervisory oversight.
• Perform environmental monitoring during fill operations.
• Perform daily checks on equipment.
• Stock the lab on a regular basis.
• Inform Manager upon observing OOS, OOT, or deviations.
• Participate in investigations of OOS results and other related studies.
• Verifies and enter results in LIMS.
• Practice Good Documentation per the Standard Operating Procedures.
• Review record keeping and documentation of laboratory equipment maintenance.
• Support department compliance and productivity goals.
• Track time worked per project.
• Detailed oriented – Able to complete required tasks and associated documentation with minimal error.
• Adaptability – Maintain positive attitude in a changing work environment.
• Communication – Effectively communicates with all levels of manufacturing and support staff.
• Escalates issues through the proper channels.

Requires vaccination against different viruses including Vaccinia virus.

The above statements are intended to describe the nature of work performed by those in this job and are not an exhaustive list of all duties. Nothing in this job description restricts managements right to assign or reassign duties and responsibilities to this job at any time which reflects management’s assignment of essential functions.

III. MINIMUM EDUCATION, EXPERIENCE, SKILLS

Education: BS in Microbiology/Biology or related field

Experience: 2-4 years in the Pharmaceutical or Biotechnology with emphasis in aseptic processing, QC microbiology, environmental monitoring, water system, Quality Control, validation and manufacturing processes.

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