I am interested in lab–related activities
| Microbiology Quality Control Technician | Chemistry Quality Control Technician | |
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| Microbiological testing finished products |  |
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| Laboratory test methods & microbiol data analysis | |
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| Calibrate/maintain testing equipment/inventory control | |
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| Aseptic techniques & good laboratory practices (GLP) | |
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| Quality assurance concepts/techniques | |
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| Quality improvement tools | |
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| Industry regulatory guidances & good documentation practices | |
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| Product testing & inspection | |
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| Environmental monitoring & good laboratory practices (GLP) | |
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| Validate data with written reports | |
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| Apply good manufacturing practices | |
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| Continuous improvement techniques | |
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| Apprentice earns 2 or more of these Industry Recognized 3rd Party Credentials | ||
| CQIA, Certified Quality Improvement Associate from the American Society of Quality | |
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| OSHA 30, 30-hour General Industry from the Occupational Safety & Health Administration | |
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| OSHA HAZWOPER 40-hour Hazardous Waste Operations and Emergency Response Standard from the Occupational Safety & Health Administration | |
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| RAC, Regulatory Affairs Certification from the Regulatory Affairs Professionals Society | |
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| Microbiological testing finished products |
| Laboratory test methods & microbiol data analysis |
| Calibrate/maintain testing equipment/inventory control |
| Aseptic techniques & good laboratory practices (GLP) |
| Quality assurance concepts/techniques |
| Quality improvement tools |
| Industry regulatory guidances & good documentation practices |
| Product testing & inspection |
| Environmental monitoring & good laboratory practices (GLP) |
| Validate data with written reports |
| Apply good manufacturing practices |
| Continuous improvement techniques |
| Apprentice earns 2 or more of these Industry Recognized 3rd Party Credentials |
| CQIA, Certified Quality Improvement Associate from the American Society of Quality |
| OSHA 30, 30-hour General Industry from the Occupational Safety & Health Administration |
| OSHA HAZWOPER 40-hour Hazardous Waste Operations and Emergency Response Standard from the Occupational Safety & Health Administration |
| RAC, Regulatory Affairs Certification from the Regulatory Affairs Professionals Society |
I am interested in clinical–related activities
| Clinical Data Coordinator | Clinical Research Coordinator | Clinical Trial Associate | Drug Safety Associate | |
|---|---|---|---|---|
| Industry regulatory guidances & good documentation practices | |
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| Clinical trial team support & operational/logistical assistance | |
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| Collect essential clinical trial data applying good clinical practices (GCP) | |
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| Data entry, maintenance, queries/resolutions, verification | |
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| Electronic data capture | |
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| Clinical trial data oversight & support | |
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| Laboratory & medical terminology | |
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| Collect, maintain, & file clinical trial documentation | |
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| Clinical trial oversight & support | |
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| Trial master file oversight & support | |
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| Drug safety management support | |
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| Medical monitoring support | |
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| SOP & regulatory compliance | |
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| Triage incoming reports (complete, legible, valid) | |
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| Safety & adverse event reporting | |
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| Investigator, sponsor, monitor roles/responsibilities | |
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| Apprentice earns 2 or more of these Industry Recognized 3rd Party Credentials | ||||
| CQIA, Certified Quality Improvement Associate from the American Society of Quality | |
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| CCDM, Certified Clinical Data Manager from the Society for Clinical Data Management | |
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| CRCC, Certified Clinical Research Coordinator from the Association of Clinical Research Professionals | |
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| Industry regulatory guidances & good documentation practices |
| Clinical trial team support & operational/logistical assistance |
| Collect essential clinical trial data applying good clinical practices (GCP) |
| Data entry, maintenance, queries/resolutions, verification |
| Electronic data capture |
| Clinical trial data oversight & support |
| Laboratory & medical terminology |
| Collect, maintain, & file clinical trial documentation |
| Clinical trial oversight & support |
| Trial master file oversight & support |
| Drug safety management support |
| Medical monitoring support |
| SOP & regulatory compliance |
| Triage incoming reports (complete, legible, valid) |
| Safety & adverse event reporting |
| Investigator, sponsor, monitor roles/responsibilities |
| Apprentice earns 2 or more of these Industry Recognized 3rd Party Credentials |
| CQIA, Certified Quality Improvement Associate from the American Society of Quality |
| CCDM, Certified Clinical Data Manager from the Society for Clinical Data Management |
| CRCC, Certified Clinical Research Coordinator from the Association of Clinical Research Professionals |
I am interested in management–related activities
| Quality Assurance Associate GXP Auditor | Regulatory Affairs Specialist | Regulatory Compliance Associate | |
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| Industry regulatory guidances & good documentation practices | |
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| Quality improvement tools | |
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| Apply good manufacturing practices (GMP) & continuous improvement techniques | |
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| Inspect vendor products (stds/specs compliance) | |
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| Inspect vendor facilities (stds/specs compliance) | |
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| Submit audit reports (compliance, correctives) | |
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| Coordinate & document internal regulatory processes | |
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| Assist in compile/prepare submission docs | |
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| Regulatory pathways/operations | |
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| Regulatory submissions/review process | |
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| Manage/integrate quality management program | |
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| Manage/integrate quality improvement program | |
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| Guidance/tech support for quality programs | |
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| Strategic planning for recalls | |
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| Apprentice earns 2 or more of these Industry Recognized 3rd Party Credentials | |||
| CQIA, Certified Quality Improvement Associate from the American Society for Quality | |
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| OSHA 30, 30-hour General Industry from the Occupational Safety & Health Administration | |
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| OSHA HAZWOPER 40-hour Hazardous Waste Operations and Emergency Response Standard from the Occupational Safety & Health Administration | |
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| CQA, Quality Auditor from the American Society for Quality | |
| Industry regulatory guidances & good documentation practices |
| Quality improvement tools |
| Apply good manufacturing practices (GMP) & continuous improvement techniques |
| Inspect vendor products (stds/specs compliance) |
| Inspect vendor facilities (stds/specs compliance) |
| Submit audit reports (compliance, correctives) |
| Coordinate & document internal regulatory processes |
| Assist in compile/prepare submission docs |
| Regulatory pathways/operations |
| Regulatory submissions/review process |
| Manage/integrate quality management program |
| Manage/integrate quality improvement program |
| Guidance/tech support for quality programs |
| Strategic planning for recalls |
| Apprentice earns 2 or more of these Industry Recognized 3rd Party Credentials |
| CQIA, Certified Quality Improvement Associate from the American Society for Quality |
| OSHA 30, 30-hour General Industry from the Occupational Safety & Health Administration |
| OSHA HAZWOPER 40-hour Hazardous Waste Operations and Emergency Response Standard from the Occupational Safety & Health Administration |
| CQA, Quality Auditor from the American Society for Quality |
FOR MORE INFORMATION CONTACT
LEWIE CASEY, CQIA,
Apprentice Program Logistics Coordinator
RX Research Services Foundation
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