What are the responsibilities and job description for the Quality Control Microbiologist position at Unicon Pharma Inc?
Description:
- The Quality Microbial Control Analyst V will act as a team member of the Quality Microbial Control department to support production of in-process and final product drug lots for customers.
- Also participate in quality testing for ongoing customer stability studies.
- Provide on-time, high quality results to meet Manufacturing demands.
- Applies job skills and company's policies and procedures to complete a variety of tasks of increased scope.
- May be assigned to work on special projects.
- Also may provide support to others in the absence of the supervisor.
- Works on assignments that are semi-routine in nature where ability to recognize deviation from accepted practice is required.
- Works on problems of moderate scope in which analysis of situation or data requires a review of identifiable factors.
- Acts as an area SME providing technical support within the department and throughout the facility.
- Applies job skills and company's policies and procedures to complete a variety of tasks.
- Running test samples for In-Process, Lot Release and Stability studies.
- Support Utility and HVAC monitoring and sampling throughout the facility
- Reviewing assays.
- Training others.
- Writing- Quality Records (Deviations, CAPA, Change Control) and Test Methods.
- Projects – such as method transfers, new instruments, method qualifications.
- Use of Microsoft Suites (Word, Excel, PowerPoint).
- Use of Laboratory computer systems.
- Potential previous use of GMP Quality Systems such as: TrackWise, LIMS.
- Works on assignments that are semi-routine in nature where ability to recognize deviation from accepted practice is required.
- Works on problems of moderate scope in which analysis of situation or data requires a review of identifiable factors.
- Apply Data Integrity principles in all aspects of work, in compliance with client's DI policies, guidelines and procedures.
- Perform other duties as assigned.
- Back-up to Supervisor – Independently making quality decisions with input
- Bachelor's Degree - Microbiology, Biochemistry or Related Science Fields
- 5-10 years’ experience