Delores Van Schaick
Cobleskill,NY
Summary
Highly motivated Quality Professional proficient in Quality Systems: Internal Auditing, Supplier Auditing, Document Control, Risk Management, Training, Investigations, RCA, CAPA, Change Control. Demonstrating excellent customer service through strong leadership, organizational and analytical skills. Self-starter/self-motivated, ability to work with little supervision. Flexibility with work schedule. Effective communication skills both verbal and written. Ability to analyze and problem solve. Working knowledge of Microsoft office, Excel, SAP Highly-motivated employee with desire to take on new challenges. Strong work ethic, adaptability, and exceptional interpersonal skills. Adept at working effectively unsupervised and quickly mastering new skills.
Overview
27
27
years of professional experience
Work History
Quality Compliance Specialist
Haleon
Oak Hill, NY
01.2012 - Current
- Management of Quality Systems (QMS) including Risk Management, Quality Council, CAPA Management, Quality Key Performance Indicators, Document Control (SOP editor/author roles), Internal and Supplier Auditing
- System owner for the Self Inspection, Internal Monitoring Audits and Supplier Management programs
- Facilitator for Risk Management and Compliance Board and site delegate for Risk Management Process Owner (RMPO)
- Supporting the Deviation process
- Provide Good Manufacturing Practice (GMP) training to onboarding new hires
- Provide Quality Coaching to Operation personnel
- Received GMP By the Sea training and Global (FDA seminar)
- Managed the Self Inspection Program - increased site awareness through continuous training initiatives and process improvements allowing a 194% increase in Self Inspection Observations and the closure of the site Risk for auditor capability while increasing the site’s Risk Model Scorecard
- Managed the Internal Auditing Program – Capability training, schedule development and adherence, trending and metrics, recruitment of auditors, increased the site’s Risk Model Scorecard
- Led the Oak Hill Site in receiving a “GOOD” rating from a Compliance Audit Group audit as the Self Inspection Audit Program was noted as strong and equated to Quality being owned by the site
- Led desktop and onsite Supplier Quality Audits
- Managed the sites GMP Gowning project, including the development of gowning stations and the revision of the GMP Hygiene and Dress Requirements procedure
- Volunteered to support the Training department in delivering site wide trainings
- Selected as a Facilitator for the Auditing Community of Practice (CoP) and facilitating the North America CoP
- Identified gaps in the Supplier Management Program and reduced vendor complaints by 50% and initiated reimbursement discussions with vendors resulting in savings of ~433,000 while in the position for 4 months
- Manage site suppliers through the vendor complaint process, working across boundaries with Quality Control Laboratory, Operations, Planning, and Logistic departments, and above site groups to ensure quality of vendor materials
- Received company auditor certification and achieved the highest score across the network for a 3-year recertification while on an Electronic Batch Record project for 2.5 years
- Received extensive experience with the Business Change Lead Role for the Electronic Batch Record project and ensured its success and delivered sitewide training.
Administrative Manager
Haleon
Oak Hill, NY
01.2008 - 01.2012
- Performed Document review of Internal and External production records
- Cross functionally served as a liaison for Laboratories, Logistics, Production, and Quality Assurance managing department workload to obtain a 100% customer service level
- Approved master documentation and released packaging records
- Proactively attended daily meetings with production to ensure their needs were met
- Reduced the turnaround time of bulks and finished goods by assuring a seamless process flow from manufacturing and packaging to the customer
- Performed resource management to support production in achieving the weekly schedule at 100%
- Selected to serve as a team member for the Operational Excellence program and reduced Laboratory Investigation Reports by 30% through process improvements.
Microbiology Analyst
Haleon
Oak Hill, NY
01.1997 - 01.2008
- Performed USP Microbial Limits and AET testing for production and stability studies with conformance to Good Laboratory Practices (GLP)
- Managed the department workload
- Proficient in analysis of bioburden, identification of microorganisms, media preparation, equipment calibration, temperature data loggers, clean room environment, and autoclave validation
- Authored Work Instructions and updated Standard Operating Procedures for increased efficiencies as a member of the Internal Quality Assurance committee
- Increased productivity with the ability to recognize individual personalities and capabilities along with mentoring and a reward system
- Improved morale and promoted teamwork through a motivational and positive perspective
- Reduced downtime by recruiting individuals for weekend work to over stock media before the autoclave validation
- Over 10 years’ experience training new employees on laboratory techniques, laboratory safety, and Microbiology test methods, allowing better efficiency through cross training and a safer place to work.
Education
A.A.S Business Administration -
State University of New York
Schenectady County Community College
Skills
- Information Gathering
- Regulatory Knowledge
- Compliance Knowledge
- Internal Auditing
- Compliance Monitoring
- Risk Management
- Document Review
- Compliance Reviews
- Audit Management
- Internal Audits
- Trend Monitoring
Core Values
- Transparency
- Respect for People
- Integrity
- Customer Focused
Affiliations And Memberships
Haleon Oak Hill, NY – Selected to serve on the site Communications Committee to publicize current events and the Business Change Lead for the Electronic Batch Record project. Volunteered to serve on the site Focus Group, Family Day Organization, Development Employee Resource Group (ERG) and Employee Involvement Network (EIN) to enhance the work environment for Oak Hill employees.
Awards
- Dean’s List
- Employee Pride Award for dedication and commitments
- Employee Recognition Awards for Teamwork
- Global Employee Recognition Awards for working across boundaries
Accomplishments
- Global nomination for obtaining the highest score throughout the entire company network during a 3-year auditor recertification while acting as the Business Change Lead on a Electronic Batch Record project for 2.5-years.
Timeline
Quality Compliance Specialist
Haleon
01.2012 - Current
Administrative Manager
Haleon
01.2008 - 01.2012
Microbiology Analyst
Haleon
01.1997 - 01.2008
A.A.S Business Administration -
State University of New York
Schenectady County Community College