Tiffanie Knobloch
Summerville ,SC
Summary
Detail-oriented Quality Assurance/Regulatory Affairs professional with 15+ years of experience in overseeing the successful execution of labeling projects ensuring all quality standards are achieved. Highly competent in directing and coaching project teams to improve efficiency and productivity. Exceptional organizational skills leveraged in managing various administrative functions to streamline business procedures and achieve daily objectives.
Overview
18
18
years of professional experience
1
1
Certification
Work History
Estimating Coordinator
Construction Services Group, Inc..
10.2023 - Current
- Participated in pre-bid meetings to gain insights into client priorities while building rapport among key stakeholders.
- Reviewed and approved invoices and payments, verifying accuracy.
- Attended project meetings to provide updates and insights on project costs.
- Prepared bids and proposals to submit to clients and secure new business.
- Developed and maintained database of cost information to use most up-to-date and relevant data in estimates.
- Streamlined communication lines between departments through the creation of a centralized database for relevant project information.
- Collaborated with project managers and contractors to obtain necessary information for preparing cost estimates.
Quality Assurance Manager
PAI Pharma
07.2007 - 08.2023
- Provided input and assessed change controls by providing an independent QA/RA review for labeling and components
- Created, revised and approved cGMP documentation for PAI Pharma and private label companies ensuring high levels of accuracy for artwork proofs, standard operating procedures (SOPs) and work instructions
- Provided technical writing for labeling, prepare and compile electronic regulatory labeling submissions in accordance with internal business processes and regulatory requirements for ANDAs, e-labeling supplements, Prior Approval Supplements, Changes Being Effected Supplements
- Managed the release of commercial labeling products through close collaboration with cross-functional departments resulting in successful product launches
- Maintained paper and electronic master label files for labeling and component compliance
- Supported commercial products launches by working cross-functionally with Regulatory Affairs, Quality Assurance, Product Development, Tech Services, Business Development, Supply Chain, Sales and Marketing and Operation to ensure all departments are fully supported by providing guidance and training on regulatory and cGMP requirements
- Coordinated and hosted FDA and on-site vendor audits as an audit scribe or document coordinator in the backroom for documentation requested during an audit.
Office Administrator
FLUOR (Government Group)
01.2006 - 07.2007
- Responsible for all administrative responsibilities during the bid proposal which included but not limited to ordering supplies, accepting, coordinating travel arrangements for candidates and management, excepted deliveries and other duties to ensure a successful business operation
- Stored, controlled, versioned, and edited all confidential bid documents
- Confirmed and documented security clearances for all personnel on-site during bid proposal.
Education
Paraprofessional -
Nicholls State University
Leadership Development Certificate -
Greenville Technical College
Skills
- Plant Management
- CGMP
- CFRs
- Quality Assurance
- Project Management
- Team Leadership
- Administrative Skills
Certification
OSHA 30
Hazwoper 40
Confined Space Entry
Timeline
Estimating Coordinator
Construction Services Group, Inc..
10.2023 - Current
Quality Assurance Manager
PAI Pharma
07.2007 - 08.2023
Office Administrator
FLUOR (Government Group)
01.2006 - 07.2007
Paraprofessional -
Nicholls State University
Leadership Development Certificate -
Greenville Technical College