Corey Sutton
Indian Land,SC
Summary
Dynamic quality assurance professional with extensive experience at Pharmaceutical Associates Inc., excelling in investigation writing and root cause analysis. Proven track record in implementing CAPA and enhancing operational efficiency. Adept at process control and fostering team collaboration, ensuring compliance with industry standards while maintaining audit readiness.
Overview
16
16
years of professional experience
1
1
Certification
Work History
Assistant Quality Manager
Nutramax Laboratories Inc.
01.2024 - Current
- Oversaw supervisors and quality inspectors to maintain operational efficiency.
- Established key performance indicators (KPIs) for team performance and quality metrics.
- Ensured compliance with all GMP requirements, regulations, and industry standards.
- Reviewed and approved SOPs, protocols, planned deviations, and CAPAs.
- Monitored environmental condition records and responded promptly to excursions.
- Conducted batch record documentation review and approval processes.
- Managed product release of raw materials and components post-testing.
- Collaborated with cross-functional teams to enhance awareness of Quality System activities.
Sr. Plant Quality Supervisor
Pharmaceutical Associates Inc.
Greenville, South Carolina
12.2017 - 12.2023
- Supervise 18, QA operations associate over 3 shifts in manufacturing, packaging, kitting, and distribution.
- Exhibited quality assurance principles to ensure the product is distributed efficiently to our customers.
- Worked closely with supply chain and logistics management teams ensuring that the distribution location received the proper product for customers.
- Coordinate workflow and prioritize staffing at three facilities located in Greenville, South Carolina.
- Primary SME for manufacturing and packaging compliance events on the shop floor.
- Initiate and write deviations for quality department.
- Perform necessary updates and biennial reviews for Sops and Forms in Quality Operations.
- Train and mentor staff to perform in-process lab testing i.e. pH, titrations, batch adjustments and bulk release testing for Quality Control.
- Support management during FDA, DEA, and other Regulatory visits/audits.
- Performed evaluations, counseling and mentoring for all direct reports.
- Maintain audit readiness by following up in area production areas.
- In-charge of releasing batches after reviewing the risk assessment and depositions.
Lead Production Operator
Ortec Inc.
10.2014 - 12.2017
- Supervise and coordinate 1st and 2nd shift chemical plant production activities.
- Operate all production equipment.
- Verify all components and materials prior to batch start-up.
- Perform lab review and approval for process adjustments.
- Perform start of batch calculations and final reconciliations on chemical batches.
Shift Supervisor
Hampton PRTF
07.2009 - 10.2014
- Supervise behavioral program for adolescent males.
- Coordinate team resources with current Medicaid, RFP and CARF.
- Responsible for direct care staff members.
- Facilitate and document therapeutic counseling sessions with adolescents.
Sr. Plant Quality In-process Quality Specialist
Pharmaceutical Associates Inc.
- Actively support manufacturing daily operations to ensure batches meet specifications.
- Perform in-process testing and sampling on pharmaceutical batches.
- Shuttle between three manufacturing buildings to provide support to compounding department.
- Work directly with compounding operators to address any processing gaps or concerns.
- Escalate real-time events to QA and Operations leadership.
- Perform other duties as assigned.
Plant Quality Inspector
Pharmaceutical Associates Inc.
- Perform routine in-process checks to ensure lots are packaged according to standards.
- Perform AQL inspections suspect lots for packaging and kitting operation.
- Perform line inspection and area release for packaging.
- Escalate compliance events to supervision and follow-up.
- Attend shift hand-off huddles and provide necessary updates to QA & Ops.
- Primary Train-the-trainer for QA packaging.
- Assist supervision with deviations as needed.
Lead Compounder
Pharmaceutical Associates Inc.
- Coordinate compounding workload to ensure rooms had necessary staffing.
- Perform weighing and dispensing for pharmaceutical batches.
- Perform in-process batch verification with QA.
- Certified train-the-trainer for compounding department.
- Perform multiple duties to ensure department met daily goals.
Education
Master of Business Administration - MBA w/concentration of Leadership
Southern New Hampshire University
Manchester, New Hampshire01.2027
Bachelor of Science - Business Administration w/concentration of Organizational Leadership
Southern New Hampshire University
Manchester, New HampshireSkills
- Investigation writing
- Quality and operations expertise
- Attention to detail
- Critical thinking
- Process control
- Titration techniques
- pH testing
- Batch formulation calculations
- Track Wise proficiency
- Red Prairie knowledge
- Salesforce experience
- SAP familiarity
- LIMS expertise
- CAPA implementation
- Kaizen methodology
- Root cause analysis
- Document control and batch review
- Packaging and distribution release expertise
- Acceptable quality limits (AQL) knowledge
Certification
- Anderson University- Certificate in Leadership
- Alison Learning- Fundamentals of Quality Assurance
- Allison Learning- Quality Engineer- Supplier Quality Evaluation & Management
- PCQI Trained (Animal Safety)
- HACCP Trained
- GMP Trained/Professional
- CFR’s Part 210 and 211: cGMPs for Finished Pharmaceutical
- Master Certified Manager of Quality (CMQ/OE) Trained
- Quality Management Foundation and Implement Training (ISO 9001:2015)
- Food Allergens Certified
Accomplishments
I have accomplished key certifications stated above that have given me the expertise to guide a team and to help companies establish long-term success. Recently I became a member of the Lancaster Leadership Commerce Association. The seven-month program is designed to both challenge and educate potential community leaders with an in-depth, balanced understanding of opportunities, goals, and needs of the community. Foster a high level of civic and community awareness and personal involvement in the community. As a Quality expert I frequently work with a variety of Quality Management Systems that involves documented procedures, change control, and risk management analysis.
Timeline
Assistant Quality Manager
Nutramax Laboratories Inc.
01.2024 - Current
Sr. Plant Quality Supervisor
Pharmaceutical Associates Inc.
12.2017 - 12.2023
Lead Production Operator
Ortec Inc.
10.2014 - 12.2017
Shift Supervisor
Hampton PRTF
07.2009 - 10.2014
Sr. Plant Quality In-process Quality Specialist
Pharmaceutical Associates Inc.
Plant Quality Inspector
Pharmaceutical Associates Inc.
Lead Compounder
Pharmaceutical Associates Inc.
Master of Business Administration - MBA w/concentration of Leadership
Southern New Hampshire University
Bachelor of Science - Business Administration w/concentration of Organizational Leadership
Southern New Hampshire University
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