Summary
Overview
Work History
Education
Skills
References
Timeline
Generic

Crystal Shirriff

Abington ,MA

Summary

Results-driven Senior Quality Control Specialist with extensive experience at Moderna, excelling in GMP compliance and change control management. Proven ability to enhance quality metrics through effective cross-functional collaboration and analytical skills. Adept at problem-solving and leading strategic initiatives, ensuring timely delivery of high-quality clinical and commercial products.

Overview

30
30
years of professional experience

Work History

Certified Pilates Instructor

Club Pilates
08.2024 - Current
  • Built and continually expanded knowledge and expertise on latest fitness trends and programs and kept class content fresh and interesting.

Senior Quality control Specialist

Moderna
Norwood, MA
01.2022 - 12.2023
  • Supported review/approval of GMP documents such as specifications, stability protocols, validation protocols analytical methods for IPC and drug substance for clinical and commercial products
  • Performed QC review and approval of analytical testing for IPC, drug substance, drug product and stability testing
  • Collaborated and tracked with CTL and global CMO on testing turnaround times to meet tight deadlines
  • Wrote and/or supported/approved OOT/OOS, deviations, CAPAs, and change controls for external sites
  • Managed/approved work order and change orders related to stability studies and sample testing conducted at multiple global CMO sites and CTL
  • Collaborated virtually with cross-functional teams to identify quality issues and develop effective solutions
  • Communicate clinical and commercial product information effectively to superiors and cross-functional team
  • Provide regular updates to leadership team on quality metrics KPIs with CMO and CTL for quality performance
  • Created stability budget plan for leadership to have a planned budgeted forecast
  • Created stability trackers for multiple global CMO’s sites for tracking commercial and clinical material for organization purposes and ease for other cross-functional access
  • Review/approval of stability protocols and managed stability testing performed at multiple CMO and CTL sites for clinical and commercial material
  • Managed change control lifecycle, presented at change review boards, opened change report follow through to closure

Senior Quality Control Chemist

Sebela Pharmaceuticals
Holbrook, MA
11.2005 - 12.2022
  • Experience includes perform testing using dissolutions, titrations, auto-titration, extractions, UV/Vis, TOC, Karl Fischer moisture testing, particle size, high performance liquid chromatography (HPLC), Ion chromatography, and FTIR
  • Supporting QC activities for early to late-stage clinical/ commercial programs
  • Knowledgeable of laboratory methods and techniques used in analytical chemistry, including USP methods
  • Creations of reagents and solutions including standardizing solutions
  • Verification of scales and pH meters
  • Calibrate, perform maintenance, troubleshooting laboratory instruments, and performed IQ, PQ, and OQ on new or loaner instruments
  • Write and/or approve investigations OOT/OOS internal
  • Follow all standard operating procedures and standard test methods
  • Ordering chemicals, supplies for the QC department, and tracked accounts
  • Train and mentor new and seasoned chemists
  • Weekly scheduling /coordination of testing for 11 chemists
  • Revising SOP’s and STM’s
  • Designee for senior QC laboratory manager
  • Attend/participate in daily and weekly production and quality update meetings
  • Coordinate pick up of samples for outside vendors for micro testing and generate sample submission forms
  • Approve certificates of analysis for in house and outside testing for release to document control

Clinical Associate Orthodontics

Dr Herb R. Nachtrab III
Weymouth
01.1995 - 12.2005
  • Dental lab retainers, mouth guards, consolation prep, X-Rays, scheduling clients, ordering

Education

Bachelor - Chemistry

Bridgewater State College
Bridgewater, MA
01.2003

Skills

  • Attention to detail
  • Math skills
  • Cross-functional collaboration
  • High volume Data Trends
  • Lead Planning Meetings
  • Develop strategic plans
  • Ability to adapt to new procedures and technology
  • Analytical skills
  • Compliance and meeting the needs of the company
  • Client assessment
  • Effective communication
  • Problem-solving abilities
  • Self motivation
  • Analytical thinking
  • GMP compliance
  • Change control management
  • Deviation management
  • Document management
  • Team leadership
  • Problem solving
  • Time management
  • Communication skills

References

References available upon request.

Timeline

Certified Pilates Instructor

Club Pilates
08.2024 - Current

Senior Quality control Specialist

Moderna
01.2022 - 12.2023

Senior Quality Control Chemist

Sebela Pharmaceuticals
11.2005 - 12.2022

Clinical Associate Orthodontics

Dr Herb R. Nachtrab III
01.1995 - 12.2005

Bachelor - Chemistry

Bridgewater State College

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Crystal Shirriff