apprenticeships in quality
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Preparing the Next Workforce
Rosemarie Christopher
October 12, 2017
Apprenticeships in Quality
Clinical Research Regulatory Quality Drug
Safety Biostats
Caregivers
Graduates
Veterans
Quality Improvement Associate Certificate
Building Quality From Ground Up
• Perfect documentation is required for Regulatory approvals
• Certifications insure industry best practices are followed: important to Clients (Internal & External)
• There are multiple career paths for Apprentices
• 87% of Apprentices are offered full time positions, much higher rate than interns
• Candidates with certifications and 1-6 years of experience are the most difficult to uncover & recruit
Professional Growth for Senior Staff
Profess. Growth
Mentorship
Delegation
Training
Build A Happy Team (Drive by Dan Pink) • Autonomy– opportunity to
manage someone • Contribution – make a
difference in someone else’s career
• Mastery – training packages available through our Foundation
Professional Growth for Senior Staff
Profess. Growth
Mentorship
Delegation
Training
Additional benefits • Mentorship – learn
material better by teaching • Delegation – unload
routine tasks • Retention – make the job
more interesting
Benefits of Delegation
False choice:
“I don’t have time to train!”
Give Receive
Story 1
Video Stories – Mentors & Apprentices
https://meirxrs.com/2017/09/12/video-case-studies-how-apprentices-are-solving-problems-in-pharma-and-food/
Questions For You:
• Do you have projects that require a large amount of routine work?
• Are there projects you are behind schedule on?
• Do you have projects that need to be checked for completeness and accuracy?
Wrap Up
• Use Quality Control Apprentices to build quality from the ground up.
• Foundation covers cost of ASQ CQIA Body of Knowledge, CQIA exam, and mentorship.
• Delegation of low-level work also improves job satisfaction for higher-level staff.
Rosemarie Christopher Cell 213-999-0138 rchristopher@meirxrs.com https://meirxrs.com/apprentices/
Appendix
Your Questions For Me
Reporting Requirements
• Apprentice has bi-weekly call with logistics coordinator • Apprentices submit bi-weekly timesheets and task
reports • Manager reviews and signs off • Manager submits quarterly performance survey • Mentor submits monthly progress report (checklist) • Foundation ensures program compliance
Responsibilities
• Accounts payable will be billed for wages, employer taxes and benefits, which account for 1.46X hourly pay according to Bureau of Labor Statistics (http://bit.ly/1tuDHWA)
• Foundation covers 8 hours training/week, certification materials and exam
• Rx Research processes timesheets, ensuring the apprentice stays on track with trainings and experiential requirements
• Rx Research ensures compliance with federal, state and employment laws and program requirements
Responsibilities
Base Pay
Supplemental pay
Retirement
Paid leave
Legally required benefits Insurance
Base pay
Other W2 requirements
Example
1 year Base Pay $15.00 $31,200
Employer Taxes and W2 Benefits* $7.25 $15,070
Contribution** $1.00 $2,080
Total Employment Cost (before Foundation support) $48,270
8 hours /week training -($4,555)
Certification materials and exam $644 Paid by Foundation
Mentorship stipends $3,000 Paid by Foundation
Total Foundation Contribution $7,799
Host Company Costs $40,471
*6.2% Social Security + 6% Federal Unemployment + 6.2% State unemployment + 1.45% Medicaid + $1.18/hour Worker’s Compensation + $2.85/hour contribution to health insurance **Search, drug testing, background checks, general liability insurance, errors and omissions insurance, payroll processing
Training topics/outcomes
Microbiology Quality Control Technician
Chemistry Quality Control Technician
Clinical Data Coordinator
Clinical Research Coordinator
Clinical Trial Associate
Drug Safety Associate
Quality Assurance Associate GXP Auditor
Regulatory Affairs Specialist
Regulatory Compliance Associate
Microbiological testing finished products Analyze microbiological test data Calibrate/maintain testing equipment Aseptic techniques Inventory control Quality assurance concepts/techniques Laboratory test methods Quality improvement tools Apply good documentation practices Industry regulatory guidances Product testing & inspection Environmental monitoring Validate data with written reports Apply good manufacturing practices Continuous improvement techniques Clinical trial team support Collect essential clinical trial data Data entry, queries/resolutions, verification Data maintenance Clinical trial operational/logistical assistance Apply good clinical practices Electronic data capture Clinical trial data oversight & support Laboratory & medical terminology Collect, maintain, & file clinical trial documentation iClinical 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 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 Industry-recognized 3rd party certification*
CQIA RAC GLPOSHA 30 OSHA HAZW OPER CRCC GCP SCDM
*Depending on the apprenticeship, 2 or more of the 3rd party Certifications will be obtained
Apprenticeships in Quality
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