Quality Assurance Manager
Resume:
LaMeka Potter
mailto:ad2kej@r.postjobfree.com
(Available for in-person interview)
Summary:
Versatile Professional with 20+ years’ experience in Quality Assurance and Control in accordance with the company's SOPs and customer specified requirements.
Reviews and Release batch records for conformance to customer requirements, specifications and regulatory requirements.
Reviews documents for cGDP accuracy as well was required to follow all FDA and OSHA compliance and SOP.
Provides non-compliance reporting utilizing JDE/AS400, showcase, quantum, and SPC software; follow-up tracking/report closures and documentation archive.
Fulfill with all company policies/procedures, safety requirements, cGMP regulations and customer requirements.
Reviews records for conformance to customer requirements, specifications and regulatory requirements.
Skills: cGMP, JDE/AS400, SPC software, SOPs, designed filing systems, PowerPoint, GDP, OSHA, NexGen, Laserfische, SAP, WMS, Validation, Auditing and Reporting, Technical writing, ASCtrak, Agile, and Oracle, Blue Mountain, NexPak, and TMS software.
Education/Certification:
Master of Business Administration, Public Health Administration Strayer University, Memphis, TN, June 2016
Experience:
Metro Logics, Olive Branch, MS
July 2023- Present
Interim Quality Manager
Company Overview: Metro Logics, Inc. (Metro) is a medical logistics service company that provides temperature sensitive storage, warehousing and rapid distribution services for perishable, biopharmaceutical, and medical materials. Metro serves the pharmaceutical, medical, and related industries throughout the United States.
Responsibilities:
Assists in developing short and long-term goals and objectives. Prepares an annual plan for auditing all departments and operations.
Executes established operational goals and ensures that institution-wide plans are complemented and supported. Coordinates internal auditing programs with those formulated by the company’s independent and regulatory auditors.
Develops policies and procedures for auditing operations in conjunction with senior management recommendations. Conducts periodic reviews of existing policies to ensure accuracy, efficiency, and effectiveness. Acts as an internal controls / system consultant.
Ensures that policies and procedures are current and in compliance with evolving regulations, legal requirements, and industry trends.
Represents (or directs representation) during company audits by customer or outside regulatory agencies.
Ensures the effective and accurate performance of Quality / Audit functions.
Oversees and reviews operational audits ensuring adherence with company policies, regulations, and industry standards. Conducts related discussions with management, develops recommendations, and provides risk assessments.
Oversees, directs, and reviews company audits. Ensures that necessary controls exist and are developed and modified as needed. Ensures the appropriate review of systems specifications, tests of transactions, control documents, documentation, and backup procedures.
Performs special investigations or audits upon the request of Senior Management.
Effectively supervises audit personnel, ensuring optimal performance.
Provides leadership to Quality/Audit personnel through effective objective setting, delegation, and communication. Conducts staff meetings as required.
Ensures that personnel are well trained, effective, and optimally used. Provides regular training as needed regarding policies, procedures, and program changes.
Coordinates the scheduling of audits and assignment of audit staff.
Prepares and maintains a manual of Quality/Audit Department policies and procedures to serve as a guide and training tool.
Conducts performance appraisals as required. Implements corrective and preventative actions as needed.
Assumes responsibility for establishing and maintaining effective communication and coordination with Company personnel and management.
Assists and supports Company personnel and management as required.
Keeps Senior Management informed of area activities and of any significant problems.
Completes and submits required reports, records, and related documents. Prepares reports of progress towards completion of the annual plan and strategic goals. Reviews and discusses audit reports with Senior Management.
Attends meetings as required.
Assumes responsibility for ensuring that professional business relationships are established and maintained with outside business contacts and external audit professionals.
Ensures that the company’s professional reputation is maintained both internally and externally.
Ensures that appropriate levels of security and confidentiality are maintained at all times.
Acts as a principal representative of the company in contact with business and trade associations and external auditors. Promotes the company’s interests.
Interact with regulated departments (Validation group, Inventory Control group, and Operators) to improve current quality programs.
Aid in the creation of SOPs and approving final documents.
Assure all employees are compliant with cGMP regulations.
Perform internal audits.
Performs and assigns training to personnel.
Manage the Document Control System.
Reviews and approves deviations, corrective actions, and preventative actions.
Assumes responsibility for maintaining quality programs in cGMP regulated environment.
Perform record reviews/data audits for controlled product.
Review SOPs, records, and related documentation for compliance.
Maintain SOPs, training files, equipment files, deviation files, and change controls.
Maintain data.
Assists with the development and implementation of effective Quality Management / Audit strategies.
Aids in preparing an annual plan for auditing all departments and operations.
Aids in coordinating internal auditing programs with those formulated by the Company’s independent and regulatory auditors.
Conducts periodic reviews of existing policies to ensure accuracy, efficiency, and effectiveness. Acts as an internal controls / system consultant.
Ensures that policies and procedures are current and in compliance with evolving regulations, legal requirements, and industry trends.
Assumes responsibility for related duties as required or assigned.
Stays informed of changing auditing procedures, policies, and industry trends.
Ensures that work area is clean, secure, and well maintained.
Attends meetings as required.
Metro Logics Inc., Olive Branch, MS
Jan 2022 – July 2023
Quality Associate/Control Specialist
Company Overview: Metro Logics, Inc. (Metro) is a medical logistics service company that provides temperature sensitive storage, warehousing and rapid distribution services for perishable, biopharmaceutical, and medical materials. Metro serves the pharmaceutical, medical, and related industries throughout the United States.
Responsibilities:
Interact with regulated departments (Validation group, Inventory Control group, and Operators) to improve current quality programs.
Aid in the creation of SOPs and approving final documents.
Assure all employees are compliant with cGMP regulations.
Perform internal audits.
Performs and assigns training to personnel.
Manage the Document Control System.
Reviews and approves deviations, corrective actions, and preventative actions.
Assumes responsibility for maintaining quality programs in cGMP regulated environment.
Perform record reviews/data audits for controlled product.
Review SOPs, records, and related documentation for compliance.
Maintain SOPs, training files, equipment files, deviation files, and change controls.
Maintain data.
Assists with the development and implementation of effective Quality Management / Audit strategies.
Aids in preparing an annual plan for auditing all departments and operations.
Aids in coordinating internal auditing programs with those formulated by the Company’s independent and regulatory auditors.
Conducts periodic reviews of existing policies to ensure accuracy, efficiency, and effectiveness. Acts as an internal controls / system consultant.
Ensures that policies and procedures are current and in compliance with evolving regulations, legal requirements, and industry trends.
Assumes responsibility for related duties as required or assigned.
Stays informed of changing auditing procedures, policies, and industry trends.
Ensures that work area is clean, secure, and well maintained.
Attends meetings as required.
Any other duties or responsibilities necessary or as assigned.
Integra LifeScience, Memphis, TN
April 2019- Jan 2022
Quality Control Specialist
Company Overview: Integra LifeScience, was founded in 1989 with the acquisition of an engineered collagen technology platform used to repair and regenerate tissue. Integra regenerative tissue technologies include products that address soft tissue, nerve, and tendon repairs and for the treatment of acute and chronic wounds, burns, as well as for plastic and reconstructive surgery. Integra has expanded its base regenerative technology product portfolio to include surgical instruments, neurosurgical products and advanced wound care products, through global acquisitions and development of new and innovative products and technologies to address unmet patient needs and improve outcomes.
Responsibilities:
Inspect and approve human tissue, materials, reagents, and supplies.
Create, maintain, and inspect to Material and Tissue Specification Sheets.
Ensure all received and approved human tissue, materials, reagents, and supplies are from approved suppliers.
Ensure all tissue remains in quarantine until released appropriately and is stored in a manner that keeps tissue separated and segregated and in approved order for easy identification and pulling for processing, labeling, etc.
Receive and review all required in-process testing results.
Perform Environmental Monitoring/Personnel Monitoring. Review and document results. Log information into appropriate database.
Perform Temperature Monitoring. Review and document results. Log information into appropriate database.
Perform pre- and post-sterilization Tissue Product Inspections and compare against the Product Specification Sheets to ensure compliance.
Perform inspections at each step of the final labeling and packaging process and ensure documentation is complete and accurate.
Obtain Tissue Retain Sample(s) for each final lot from distribution team and place in the appropriate area in the Tissue Retain Sample Storage Area. Ensure documentation is complete and accurate.
Complete all documentation prior to submitting to QA.
Log donors into all applicable databases.
Prepare trends and graphs.
Maintaining and provide donor metrics to management.
Assist in creating/revising policies, procedures, specifications, and forms for Donor Eligibility program.
Approve incoming materials by confirming specifications, conducting a visual and measurement test, and rejecting and returning unacceptable materials
Approve in-process production by confirming required specifications, conducting visual and measurement tests, and communicating the required adjustments to the Quality Director
Approve all finished products by confirming specifications and conducting required tests
Return products for re-work if needed and complete documentation to confirm re-work
Document and update inspection results by completing reports and logs
Keep measurement equipment operating by following operating instructions and calling for repairs.
Maintain safe work environment by following standards and procedures and complying with legal regulations
Coach and mentor junior employees; seek opportunities to grow leadership in others
Update job knowledge by participating in educational opportunities, reading technical publications, attending seminars, watching industry videos, etc.
Accomplish organization mission by completing related results as needed
Any other duties or responsibilities necessary or as assigned.
PharMEDium, Memphis, TN
June 2017- April 2019
Quality Assurance Supervisor
Company Overview: PharMEDium is the leading provider of pharmacy-outsourced, ready-to-use compounded sterile preparations (CSPs). PharMEDium operates 4 state-of-the-art, large-scale, 503B Outsourcing Facilities which are registered with the U.S. Food and Drug Administration (FDA) and state Boards of Pharmacy nationwide.
Responsibilities:
Assist the Quality Manager with all quality operations and responsibilities
Ensure compliance to procedures and address non-compliance issues.
Assist the Quality Manager in conducting internal audits of processes, systems and procedures.
Participate in cross-functional teams to identify effective corrective and preventive actions to improve process quality.
Daily activities will include but not limited to: pooling, subassembly and final batch processing, label and packing, environmental monitoring, training of specific procedures.
Conduct root cause analysis for compounding errors and in-process errors generated at the facility during all phases of the production process.
Assist Quality Manager in assuring the timely closure of incident complaints.
Initiate, write, review and revise SOP’s as needed to assure compliance and continuous improvement.
Assist in the collection and compilation of data for submission of all DEA related reports which include ARCOS reports, Procurement Quota Requests and Year End Reports.
Coordinate and schedule testing of all product for the on-going stability and on-going sterility monitoring programs with the appropriate contract labs (ensure product is produced and shipped to the appropriate lab in a timely manner).
Perform review of quality related documents generated at the facility.
Supervise the work of 6 to 15 documentation clerks
Responsible for daily quality operations within the labeling/packing operations (non-aseptic operations) department. Ensures compliance to procedures and addresses non-compliance issues.
Provide direction, scheduling and training of the QA Technicians and associates on new systems, procedures, and day to day activities.
Conduct internal audits of processes, systems and procedures.
Participate in cross-functional teams to identify effective corrective and preventive actions to improve process quality.
Assist Quality Manager to assure timely closure of audit items.
Provide reports from QA and data to support other business functions as needed for continuous improvements efforts within the facility.
Conduct root cause analysis for compounding errors and in-process errors generated at the Memphis facility during all phases of the production process.
Responsible for tracking product lots from the generation of batch records through the final disposition. This will be done through the issuance of periodic reports to management that detail the status of all lots in progress.
Other duties and responsibilities as assigned.
PharMEDium, Memphis, TN
Apr 2015 – June 2017
Quality Associate
Responsibilities:
Assist the Quality Manager with all quality operations and responsibilities at the Pain Management facility.
Ensure compliance to procedures and address non-compliance issues.
Assist the Quality Manager in conducting internal audits of processes, systems and procedures.
Participate in cross-functional teams to identify effective corrective and preventive actions to improve process quality.
Daily activities will include but not limited to: pooling, subassembly and final batch processing, label and packing, environmental monitoring, training of specific procedures.
Conduct root cause analysis for compounding errors and in-process errors generated at the facility during all phases of the production process.
Assist Quality Manager in assuring the timely closure of incident complaints.
Write, review and revise SOPs as needed to assure compliance and continuous improvement.
Assist in the collection and compilation of data for submission of all DEA related reports which include ARCOS reports, Procurement Quota Requests and Year End Reports.
Coordinate and schedule testing of all products for the on-going stability and on-going sterility monitoring programs with the appropriate contract labs (ensure product is produced and shipped to the appropriate lab in a timely manner).
Perform review of quality related documents generated at the facility.
Supervise the work of six documentation clerks
Other duties and responsibilities as assigned.
KIK Custom Product, Memphis, TN
Mar 2009 – Apr 2015
Quality Assurance Release Specialist
Company Overview: KIK Custom Products is the manufacturing partner to some of the world's largest retailers and brand owners including Johnson & Johnson, P&G, Henkel, and Novartis. KIK Custom Products Inc. engages in the contract manufacturing of consumer-packaged goods for retailers and brands in Canada and the United States. It offers personal care, including bath and shower products, baby care products, creams and lotions, deodorants, fragrances, hair care products, men's grooming products, salon and spa products, and styling and treatment products; home care products, such as air care products, dishwashing products, pet care products, polishes, surface cleaners, bleaches, and oven care products; and over-the-counter and pharma products that comprise analgesics and depilatories, as well as oral, skin, and sun care products.
Responsibilities:
Performed review and approval of executed batch records.
Reviewed documents for Good Documentation Practices (GDP) accuracy as well was required to follow all FDA and OSHA compliance and SOP.
Performed product final release and provide documentation to customer.
Reviewed batch records for conformance to customer requirements, specifications and regulatory requirements.
Reviewed batch records for completeness of information.
Followed up and locate incomplete information.
Communicated with customers in resolving batch record discrepancies.
Completed assigned Annual Product Reviews in accordance with the company's SOPs and customer specified requirements.
Fulfilled with all company policies/procedures, safety requirements, GMP regulations and customer requirements.
Provided non-compliance reporting utilizing JDE/AS400, showcase, quantum, and SPC software; follow-up tracking/report closures and documentation archive.
Compile batch record dockets.
Verify quantity to ship with customer and distribution
Other duties and responsibilities as assigned.
References Available Upon Request
Contact this candidate