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