USA - Quality Control Analyst I

Pay range: 25-28/hr
*depending on experience

Summary:
• Conduct environmental monitoring of ISO 5, 7, 8, and 9 cleanrooms at manufacturing facilities along with Water collection. Support Microbiology analysis such as raw materials, in-process and finished goods products samples at manufacturing facility.
• Conduct Microbiological analysis on raw materials, initial, in-process and final products, and samples collected from the environmental monitoring programs at manufacturing facility.
• Testing as required supporting Endotoxin testing, Bioburden analysis, growth promotion, Will be required to read microbial plates and interpret test results.
• QC Data entry in Sample manager- LIMS
• Complete all testing, including special project / protocol testing in a timely and appropriate manner.
• Perform equipment maintenance and calibrations as required.
• Maintain data integrity and ensure compliance with company SOPs and specifications, FDA, GLP, QSR and cGMP regulations.
• Perform/or support all NCRs, CAPAs, and LIRs and be the point of contact for other departments for updates.
• Participate in functions involving teams, which impact production, increase efficiency, solve problems, generate cost savings, and improve quality.
• Perform laboratory and manufacturing audits as required. Audit and update, as required, plant/lab SOPs.
• Ensure Environmental Monitoring area is always maintained in a GMP state while following all EHS and 6S guidelines.
• Flexibility in performing other duties, as assigned, or as business needs require.
• Works and communicates effectively and professionally with others inside and outside the company.
• Weekend work may be required as needed to meet production timeline schedules.

Qualifications
Ability to handle multiple tasks concurrently and complete tasks in a timely
manner.
• Effective organizational skills and ability to plan and suggest resolutions
to technical problems.
• Demonstrates some knowledge of assays/equipment in functional
area. Computers literate and competent with a general knowledge of
word processing and spreadsheets (such as Microsoft Office).
• Proficient use of laboratory equipment and tools. Must be detail oriented, conscientious, and responsible. Must have effective verbal and
written communication skills. Some knowledge of applicable CTP/SOPs,
EHS requirements, FDA Regulations application of CGMP/GDPs.
• Must be able to learn about new computer systems and programs in a timely
manner. Must be able to learn new computer systems and programs in a
timely manner.

Education and/or Experience
• B.S. degree in Microbiology, Biology; minimum 1-2-year experience in Pharmaceutical/Medical Device industry preferred.