USA - Quality Control Analyst I

2 weeks ago

Hayward, California, United States Planet Pharma Full time $131,200 - $142,400 per year

Job Description
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.

The Planet Group of Companies is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees.

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