Quality Assurance Specialist/ Manager
Resume:
Charles A. McRant
********@*****.***
PROFESSIONAL SUMMARY
Dynamic leader/contributor/ facilitator with proven quality assurance experience
External and internal audit preparation, response and internal audit performance
Experienced in contract manufacturer and customer relations
Documentation in accordance with current good manufacturing practices (cGMP)
Strong interpretation of standard operations procedures for operational/ regulatory compliance
Knowledgeable of standardization/calibration of equipment for manufacturing
EXPERIENCE
Bachem Americas (09/2022- 10/ 2024)
Senior Quality Assurance Specialist (Compliance and Manufacturing Support)
Served as SME for Quality Events (deviations, change controls, laboratory investigations and CAPAs) to maintain operational compliance, process improvement and audit readiness.
Interpret/ suggest revisions for SOPs for continuous improvement and operational compliance.
Utilized Master Control software (QMS) to record cGMP tasks involving deviations, CAPAs and Document Revision
Retired (decommissioned) SOPs, REQs, and specifications observed to be no longer applicable or obsolete
Supported Senior leadership with KPI reports for tracking/ trending purposes
Lead cross functional team in larger scope operations to assess customer/ patient safety/ product/operational impact and company compliance with applicable regulatory requirements.
Served as liaison for customers and on-site production to resolve quality events according to customer quality technical agreements (QTA)
QA Manufacturing support for Technology Transfers
Worked independently with cross-functional teams to support manufacturing operations
Performed line clearance, internal audits and GEMBA walks in ISO 7/8 conditions
Successfully worked to maintain timely reporting and operational compliance.
Served as a QA team representative communicating pressing issues to Senior Management
Operated under cGMP standards for all operations
Tracked team metrics including time reporting, team member training status, deviation/ investigation and change control status.
Worked with HR to resolve QA team questions/ concerns and internal conflicts with team members
Shire Pharmaceuticals (Contractor) (03/2022- 08/2022)
Compliance Investigator
Used technical writing skills to produce reports accurately reporting events and corrective actions
Utilized Trackwise software to record cGMP tasks involving deviations, CAPAs and Document Revision
Utilized Veeva Vault software to review cGMP Standard Operating Procedures, Validations and Risk Assessments
Worked independently with cross-functional teams to support manufacturing operations
Successfully worked to maintain timely reporting and operational compliance.
Served as a team representative communicating pressing issues to team supervisors/ management
Operated under cGMP standards for all operations
Lead cross functional team in larger scope operations to trending investigations
Kite Pharmaceuticals (Contractor) (08/2021- 02/2022)
Senior Quality Assurance Specialist II
Reviewed and released cGMP raw materials for use in cancer treatment therapies
Made patient/ product safety decisions in real time based on documentation in material release packets
Performed QA review for material change control, deviations and laboratory investigation reports (LIR)
Collaborated across QA/QC functional groups for process improvement
Performed internal audits of QC laboratory spaces for compliance with SOPs and applicable regulations
Reviewed deviations for patient, process, product impact
Archived records for quick retrieval for audit readiness
Performed and ensured proper disposition, segregation and inventory reconciliation of materials
Plastikon Healthcare ( Position eliminated)
Quality Manager (12/2020- 03/2021)
Served as SME for QA related functions of organization
Oversaw batch review/ release
Served as a direct client liaison for specific project related QA product/ client relations and support by writing Supplier Corrective Action Report (SCAR)
Coordinated and worked with Operation Managers and Engineers in writing process changes and new product manufacturing practices
Communicated to Executive Management potential risks and strategies for production
SME in Change Management in BPRs, SOPs, Forms and Specifications
Facilitated contact in writing, email and in person with third party contract manufacturers for business needs.
Wrote and delivered corporate responses for Customer Complaints
Oversaw operations team members in varying roles to ensure compliance with cGMP/ SOPs
Implemented and wrote CAPAs to address deviations or other issues in SOPs, batch production records, and material handling
Worked both independently and with other departmental personnel in cross functional teams
Reviewed process, product and equipment related verification and stability reports
Updated Materials from active to inactive (decommissioned) upon project completion or inventory exhausted
Organized Material Review Board Meetings for disposition.
Conducted team member interviews for internal investigation to be written into final report
Maintained Inventory of quarantined materials and products.
Reviewed OOS investigations with Quality Control for final product disposition
Nutramax Laboratories, Lancaster, SC (07/2014- 07/2020)
Senior Quality Assurance Specialist
Single point of contact for Customers liaison for specific projects, client relations and QA support
SME for compliance with New Product development with Project Managers and Process Engineers authoring revisions in Change Management and new product launching.
Communicated to Executive Management potential risks and strategies for production
Was a principle participant in writing, reviewing and approving change control for SOPs/ Forms
Retired (decommissioned) SOPs, equipment and specifications observed to be no longer applicable or obsolete
Facilitated contact in writing and in person with third party contract manufacturers for business needs
Participated/ performed, and wrote responses to internal audits and participated in regulatory inspections
Wrote and delivered corporate responses for Customer Complaints
Oversaw a team of over 15 people in varying roles to ensure compliance with cGMP/ SOPs
Implemented CAPAs to address gaps in SOPs, batch production records, and cleaning practices
Composed audit responses for the affected departments with observations in internal audits
Worked both independently and with other departmental personnel in cross functional teams
Reviewed process, product and equipment related verification and stability reports
Taught classes on new software rollouts to stakeholders
Conducted team member interviews for internal investigation
Maintained Inventory of quarantined materials and products
Reviewed OOS investigations with Quality Control for final product disposition
Maintained spreadsheet for turnaround times from sample delivery to product release
Reviewed and approved Qualification Protocols/ Calibration documents
SME for Compliance Software Implementation
KED PLASMA, INC, Winston-Salem, NC/ El Paso, TX (08/2008– 07/2014)
Quality Assurance Specialist
Worked in fast cGMP environment for top volume donation center in the country (El Paso, TX at the time)
Verified plasma donor and equipment records for accuracy and compliance with all applicable GMP and CFR codes
Verified shipment and source plasma for completeness, accuracy and compliance with all cGMP’s
Wrote proposals for changes in procedures to increase workplace safety and efficiency
Tracked reports of deviations with a calendar and database for timely submission and closure per SOP's
Conducted meetings with line staff, management, and medical personnel to address concerns.
Actively participated in facilitating information to regulatory agencies during external audits.
Wrote audit responses to external and corporate audits
Initiated product recall notifications to manufacturing customers
Daily Review of electronic database and hard copy documents to ensure employee adherence to procedures
Review of adverse reaction reports with medical staff to assess donor and product safety.
Electronic and hardcopy tracking of procedural deviations for investigation and closure
Decommission equipment for removal from facility when needed to reflect current active on site inventory
Inspected incoming shipments of materials to ensure suitability for manufacturing
Acted as liaison between line staff and management to foster communication of worker concerns/observations
Approved Validation documentation for equipment
Verified Software data for center remediation operation and data migration
Talecris Biotherapeutics Inc. (Formerly Bayer Pharmaceuticals), Clayton, NC (05/2005 –08/2008)
Assistant Chemist
Worked in a cGMP setting to record all testing as per in-house specifications & test requests.
Performed quality testing on human blood plasma medicines including solubility, protein content, moisture levels
Prepared general laboratory paperwork such as recording analysis results, tracking samples, completing bench sheets, and maintaining laboratory logbooks
Recorded work on official accountable documents to cGMP standards
Assisted in validation on product controls for data management
Wrote proposals for new processes to increase work efficiency and team building.
Prepared general paperwork such as recording analysis results, tracking samples, bench sheets, and maintaining logbooks
Wrote investigation reports in Trackwise and data reporting in LIMS
SOFTWARE
Donor Management Systems (DMS)
Sample Tracking Inventory System (STIS)
Laboratory Information Management Systems (LIMS)
Trackwise
Master Control
Intelex
Oracle EBS
Agile EBS
Veeva Vault
SAP
Facilworks
Dickson Alarm
EDUCATION & PROFESSIONAL DEVELOPMENT
Master of Science in Nutrition, North Carolina State University - Raleigh, North Carolina Minor in Food Safety
Bachelor of Science in Biology, Saint Augustine’s College - Raleigh, North Carolina-Magna Cum Laude
Foundations of Leadership, York Technical College (2018)
Preventive Control Qualified Individual (PCQI) -American Feed Industry Association (2017)
Franklin Covey- Seven Habits of Effective People (2016)
FAAR Effective Leadership Training (2015)
Contact this candidate