Quality Assurance Customer Service

April Bond

**** ***** ***** **., ******, NC *****

919-***-**** cell

E-mail acsomm@r.postjobfree.com

Objective: To obtain a position utilizing my managerial, documentation retention, authoring, customer relations, and problem-solving skills, drawing on my clinical research and pharmaceutical knowledge gained from previous positions, and education.

Employment:

2014 – 2015 Manufacturing Compliance Review Associate

KBI BioPharma

Reviews executed manufacturing records (batch records, solution records, equipment preparation records, processing assembly records) for documentation and compliance.

Facilitates comment resolution and notations for manufacturing records and logbooks within the manufacturing group and QA.

Performs manufacturing compliance audits through on-the-floor inspection and documentation review.

Maintains and tracks review progress for manufacturing records and logbooks, to ensure timely review and department client due dates are fulfilled.

Tracks progress and status for the manufacturing assigned deviations and CAPAs using databases, to ensure timely review and department and client due dates are fulfilled.

Collect and input analytical/ microbial data into batch records prior to delivery to QA review team.

Works with Area Managers and QA to help provide necessary information and documentation to resolve deviation investigations, change controls, and CAPAs in a timely manner.

Author and Revise controlled documents (SOPs, Manufacturing Records, Specifications).

2012-2014 Quality Assurance Specialist (Consultant)

Cytonet LLC

Performed Quality Assurance functions supporting manufacturing activities.

Assisted in the development, review and revision of Standard Operating Procedures for Durham manufacturing site.

Wrote, reviewed and updated protocols, reports and other documents, as needed.

Supported implementation of Raw Materials Testing Program by revising materials specifications.

Supported Compliance Assessments and Internal Auditing including reports.

Supported implementation of vendor or supplier qualifications.

Supported employee training management.

Supported the preparation, review, issuance, archiving, retrieval, and/or destruction of documents and records as applicable.

Supported and initiate deviations, investigations, complaints and CAPA systems.

Provided clinical inventory management support.

Supported the preparation of process kits.

Reviewed and releases incoming materials.

Reviewed OPO Contracts and CLIA certificates.

Identified any areas for improvement in existing processes/systems to superiors.

Participate as a team member of a process improvement project.

Signature authority for HQA by discretion

2008-2013 Document Control Manager/QA Specialist (Consultant)

Tranzyme, Inc.

Serves as management staff member responsible for overall Quality program.

Develops applicable company Quality strategy, policies, procedures, etc. to ensure compliance with applicable regulations and company philosophies.

Conducts quality assurance audits and audit follow-up of company vendors and internal quality system and contracted projects, as appropriate, in accordance with quality assurance procedures and SOPs. Develops audit checklists and write QA audit reports.

Develops and presents regulatory presentations and training in GxP, 21 CFR Part 11, and other pertinent topics and regulations.

Ensures the compilation and maintenance of pertinent documentation (e.g., files) required for regulatory compliance for assigned clinical research projects.

Establishes and meets quality system objectives and advised senior management of quality issues and strategies.

Establishes policies, procedures, and standards of performance for regulatory compliance, corrective and preventive action, validation, internal and supplier auditing, change control and documentation, product labeling and packaging, calibration, quality training, complaints, and supplier quality.

Maintains the Company’s files

oPreclinical and clinical (electronic and hard copies)

Assigns file names

Maintains current FDA Correspondence

Permits access to files to authorized persons

Liaison to Company’s CRO with respect to maintenance of web portals and naming conventions

Maintain all training records by maintaining the training database, training files and scheduling annual reviews.

Regulatory duties include writing or revising SOP documents, and safety manuals as well as interpreting and enforcing FDA, and OSHA requirements.

Developed and implemented a successful, and efficient, system for storing and accessing clinical, regulatory, and toxicology documents.

Review CRFs (Case Report Forms) for completion, accuracy and correctness.

Official Representative for Tranzyme, Inc. in regard to ClinTrials.gov.

Performs vendor audits

Interface with all levels of personnel in resolving issues.

Assist with revising Informed Consents, and Study Protocols

2009 - 2012 Quality Assurance Manager (Consultant)

Kainos Medicine USA, Inc.

Involved in all QA activities and in all QA related trouble shooting

Keep up to date with all related quality legislation and compliance issues

Determined and created in-house quality procedures, standards and/or specifications

Investigated and set standards for quality/health and safety

Ensured that manufacturing processes comply with standards at both national and international level

Worked with operating staff to establish procedures, standards, systems and procedures

Determined training needs

Acted as a catalyst for change and improvement in performance/quality

Monitored performance

Conducted all internal audits

2006 - 2008 Quality Assurance Coordinator

Serenex, INC.

Assisted with 501k regulatory submission at Medical Device company

Implemented and maintained quality systems.

Assured that no product is released until its quality had been deemed satisfactory.

QA duties encompass the verification and validation of manufacturing processes, and procedures

Maintained employee training files and safety records.

Regulatory duties include writing or revising SOP document, product labeling and safety manuals as well as interpreting and enforcing FDA, cGMP and OSHA requirements; review and oversight of CAPA and nonconformance trends and reports; managing vendor inspections.

Developed and implemented procedures for Corrective and Preventive Action (CAPA)

Assured that products are manufactured, processed, packed and held in accordance with Standard Operating Procedures, current Good Manufacturing Practices (cGMP) and customer specifications.

Drafted detailed written instructions for the manufacture and quality control testing of material, ensuring full compliance with cGMP.

Reviewed and approve batch record documentation prior to customer approval and use on manufacturing floor.

Reviewed batch record supporting documentation (i.e. logbooks, reports).

Coordinated the performance of investigations and corrections for incomplete/unexplained issues found during the manufacturing process.

Ensured all production and manufacturing areas were sanitized and lines were properly prepared for aseptic filling of sterile pharmaceutical products.

Verified that cleanroom suites were adequately prepared for daily production of sterile pharmaceutical products including but not limited to the following: sanitization, machine setup, parts washing, and preparation sterilizer operations - loading and unloading, staging of components.

Tracked and ensured completion of corrective actions.

Assisted with the completion of internal facility audits.

Notified impacted departments of any issues, which may impact the customer (i.e. shipping, quality issues, and etc.).

Notified Management of any issues that may become a compliance issue.

Communicated with clinical sites in relation to Informed Consents, and shipment of samples.

Wrote or revised 67 manufacturing and quality SOPs

2001 - 2006 Quality Assurance Administrator/Document Control Manager,

Clinical Trial Services

Managed all regulated documents, such as SOP’s, manufacturing procedures, clinical protocols, etc., in a secure environment.

Applied standardized processes for document authoring, review, approval, release, change and archiving.

Developed and enforced the use of approved, standardized templates, and control document access and security.

Ensured compliance with regulatory requirements (GMP) related to the management of key records in both paper and electronic forms, as well as ensured support for electronic records and signatures.

Assisted Quality personnel as needed, including, but not limited to, the Director of Quality.

Actively participated in MHRA, and FDA Audits.

1994 - 2000 Packaging Engineer, Bristol - Myers Squibb

Provided container closure system support on cross-functional teams. Responsibilities included, but were not limited to: sourcing, testing, qualifying, and documenting container/closure systems across a variety of types of materials and formats including glass vials, glass syringes and rubber stoppers.

Conducted tests on alternate packaging materials and final package for stability studies.

Coordinated the packaging of stability supplies for new products.

Recommended improvements to packaging component design.

Executed successful projects according to established objectives, timelines and costs.

Coordinated both internal and external resources to complete projects.

Education/Affiliations:

2012 - Present Currently pursuing B. S. Biology, Ashford University

2008 B.A Business Organization Management, Ashford University

2007 Completed “Quality Engineering” (2006 Edition) – ASQ Certification

2006 A.A. Business Administration, Piedmont Community College (Member of National Dean’s List, 2004-2006)

2006 Completed “Basic Communication Skills Used in Auditing” (2005 Edition) -ASQ Certification

2006 – Present Member of American Society for Quality (ASQ)

Skills:

Professionally trained on FDA regulations, SOP’s, ISO 9000 standards GLP, and GMP

Conducted training on “Effective Communication for the Quality Department,” “GMP Documentation,” and “Communicating with an International Audience”

Intermediate knowledge of MS Office Suite

Experience with Peachtree, QuickBooks, Medisoft, Misys, SMS, Medix, and IDX

Completed workshops: Telephone Etiquette, Coping Skills for Customer Service, Tool to Ensure Compliance, and Training the Trainer

Extensive experience in the preparation, review, and approval of submission materials, validation packages, standard operating procedures, and other pertinent documents to ensure operational compliance with cGMP, and cGLP standards.

Proven ability to work effectively with teams and maintain a well organized, productive, integrated support unit.

Solid experience assisting with the creation of strategies, processes, and plans that enhance operational compliance and ensure FDA approvals.

Demonstrated success with regulatory and quality initiatives during periods of tremendous organizational growth and change.

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