What are the responsibilities and job description for the QC Analyst position at Biomat USA Inc?
Do you want to join an international team working to improve the future of healthcare? Do you want to improve the lives of millions of people? Grifols is a global healthcare company which, since its foundation in Barcelona in 1909, has been working to improve the health and well-being of people all over the world. Our four divisions - Bioscience, Diagnostic, Hospital and Bio Supplies - develop, produce and market innovative medicines, solutions and services in more than 100 countries and regions.
QC Analyst
SUMMARY:
Perform quality control testing of Plasma and Pools, processing Red Blood Cells Units with minimal supervision. Uses knowledge of cGMP and corporate policies to resolve routine problems.
ESSENTIAL JOB FUNCTIONS:
- Perform quality control testing for plasma and processing Red cells units according to approved Standard Operating Procedures and cGMP regulations.
- Complete testing documentation and data entry as required for procedures and tests performed.
- Apply knowledge of analyzes issues and uses judgment to make decisions.
- Utilize cGMP practices in documentation and execution of job functions.
- Perform instrument calibration or qualification according to written procedures.
- Write and revise SOPs and/or Validation Protocols.
- Perform testing as needed to generate data for Validation and Special Projects.
- Fulfill requests from management for assistance in other matters as needed.
- Accountable for following Standard Operating Procedures (SOPs) and adhering to cGMP guidelines.
- Review documentation on trained tasks as assigned by Lab Supervisor.
QUALIFICATIONS/EXPERIENCE:
- B.S. in Microbiology, Chemistry, Biochemistry, Biology, or related science discipline.
- At least two years of experience in a laboratory setting. Work in a regulated environment (FDA, EPA, etc). is preferred, but not required.
- Familiarity with chemical, biochemical, and/or microbiological testing is necessary. The individual should have experience in one or more of the following analytical instrumentation: HPLC, GC, UV/Vis Spectrophotometer, IR spectroscopy, and/or total airborne and viable airborne particulate counters. Good communication skills, detailed-oriented, and able to work well with others are necessary qualities. The individual should be flexible and be able to handle multiple priorities. Able to use personal computer for data entry. Perform math calculations involving dilutions, fractions, decimals, and percentages. Understand and follow instructions, record information, find solutions to practical problems or request assistance.
WORK ENVIRONMENT/PHYSICAL DEMANDS/TRAVEL:
- Internal – Frequent contact with Manufacturing, Facilities, and Receiving personnel. Frequent contact with management.
- External – Frequent contact with technical service representatives. Contact with vendors may be required.
- Direct Work of Others: None.
- Decision Making: Analyses issues and exercises judgment within defined procedures to determine appropriate resoltion to problems. Escalates non-standard problems to more experienced analysts or area management. Prioritization of work with direction of Manager.
- Physical Demands: Occasional exposure to infectiour materials (human source products), toxic chemicals, chemical fumes and odors, electrical hazards, temperature extremes when going to and from coolers and freezers.
- Stressors: Position may be assigned to one of three eight-hour shifts (e.g., 4 AM – noon, noon – 8 PM, 8 PM – 4 AM). If so, shift work may be required during manufacturing of immunotherapy products. In addition, long or unusual work hours may be required for quality control testing during manufacturing of immunotherapy products.
EEO Minorities/Women/Disabled/Veterans
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Location: NORTH AMERICA : USA : FL-Boca Raton:USBOCLA - RPSTO
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