Dana Hawkins

• Air Logistics Control Tower QA Advocate - Promoting and Maintaining high industry standards.
• Dependable Customer Experience communicator - priorities achieved through Client and Regulatory audits, audit prep, report and responses.
• Quality, Safety, Health, and Environmental (QSHE) Local Quality Manager (LQM) - Ensures compliance with QuickSTAT/Kuehne & Nagel, client and regulatory standards ie ISO 9001,14001, TSA...
• Interviewing and Investigating HSE & OSHA incidences, injuries...
• Review Edit & Approve Quality Investigations/Complaints/Non-conformances ensuring effective CAPA implementation.
• Verify compliance of Sensitec- Temperature monitoring system located necessary for Temp Controlled shipments.
• Responsible with Operations to set standards to approve/reapprove Critical Suppliers & Service Suppliers i.e. DV-10, LN2 dewars, O2 monitor, Dry ice...
• Record and communicate QS Local Change Controls.
• Conduct External Audits, Internal Audits/Self inspections which reinforces adherence to regulatory standards, and ability to meet client needs.
• Contributions with Special Projects, Local QMS meetings, NDAs, Client questionnaires.

Review and Approve Client Project Requests against CCL proposed Master: Product dimensions, Art work, quantity, barcode/EudraCT, count, expiry mfr date outlines and randomization plan (if requested).

Issue QA Approval of Client/CCL Artwork after review of: Booklet/Label negotiated specification quotes, client requested translation, color, dimension, material, global vision data approval...

Approve Booklet & Label Lots into Inventory Mgt Data System after lot review.

Successfully communicate with production daily scheduled shipping and challenges of the printing jobs.

Supervise inspectors review of Artwork, review booklet/label approval and prioritizing printed job

Issue Final Disposition of the printed jobs.

Post disposition, prepare customized client requested C of C's to accompany packed jobs for client distribution.

Support the preparation and implementation of operational SOPs in cGMP Environment.

Manage the establishment and maintenance of Quality Agreements (QAGs) for clinical and commercial products / projects:

Draft/revise various/numerous QAGs based upon Gilead Quality System requirements and industry standards/best practices.

Develop negotiation strategies and ascertain the completion of applicable review of QAGs by key stakeholders & Legal, obtaining leadership approvals to ensure Gilead's position is operationally correct and accurately reflected in the QAG. Drives alignment between QAG and associated business agreement

Facilitate meetings with external parties (CMOs, CTLs, GMP Material Suppliers, GMP Services Providers) and internal stakeholders/SMEs and facilitates the review and negotiation of QAGs

Prepare the final QAG package (document clean up) for authorized approval signatures and publishing in global electronic QAG life-cycle management system / repository.

Manage the Global QAG database/tracker to reflect real time data/status for establishing and reporting metrics

Provide SME training and mentoring to QAG team or workstream leads to ensure consistency of QAG deliverables, as needed.

Identify and frame QAG project risks and issues

Drive accountability for assigned Stakeholder action items and resolution of issues

Assist with the development and implementation of Global QAG Program initiatives:

Create/roll out of global standard, global SOP, work instruction/job aids

Create / roll out standardized fit-for-purpose QAG templates

Streamline QAG Tracking tools

Create training materials

Report on key accomplishments, issues, risks, and path forward.

Ensure all deliverables and commitments are met and the project is in compliance with relevant standards and methodologies.

Communicate on risks affecting critical path.

Responsible for investigational and commercialization of GMP QA activities to ensure compliance with local, state, federal, and global GMP regulations.

Communicate with CMO's on the review and release of drug substance, drug product and packaging/labelling batch records and associated documents (e.g. change controls, deviations, etc.).

Audit and release clinical manufacturing, validation and commercial batch records for completeness and accuracy.

Review and approve GMP deviations, CAPA's, investigations and change controls.

Work with CMC, Quality Assurance and Regulatory Affairs to identify, communicate and resolve potential quality issues arising during manufacturing operations. Monitor trends or signals in potential product quality issues.

Manage all assigned Contract Manufacturing Organization (CMO) including temperature excursion documentation for Cara files, ensuring electronic and original documents are filed appropriately.

Establish and maintain GMP Standard Operating Procedures to maintain quality systems with current regulations and industry standards.

Support phase III and commercial validation activities including the review of regulatory submission documents.

Perform audits (CMO and internal) according to the audit plan.

Coordinates and reports at the Cara GMP “Management Review” meetings

Supports the Head of QA to host, lead back (War) room during Cara inspection readiness activities and during all regulatory inspections, as assigned.

Additional assignments may include but are not limited to:

Assisting to perform Internal audits or system audits as assigned

Authored Standard Operating Procedures

Review and Approve IQ OQ& PQ, Validation Protocols

Review and Author Client-Vendor Quality Agreements

Directed and Managed Review of Batch Records

Issued Dispositions of Product Batch Records

Managed Disposition of Raw Materials and Packaging Components

Authored or Approved Deviations and Document Change Revisions

Conducted Internal Departmental Audits

Reviewed Analytical and Microbial Reports, perform analytical verification

Approved Cleaning Validations

Supervised log control of CAPA's, Document Change Requests, Deviations, Lab Investigations, CofA's

Maintain Training Records

Manage customer Complaints

Host FDA Inspections

Initiate and maintain External Vendor qualification audits/communication.

Oversaw the scheduling, documentation, and follow up on audits of domestic and foreign suppliers of active pharmaceutical ingredients, excipient materials, packaging components contract service providers.

Directed and Managed Review of Batch Records.

Issued Dispositions of Product Batch Records.

.Authored Standard Operating Procedures, Compiled Computer Validation of SOP’s

Managed Disposition of Raw Materials and Packaging Components.

Authored and Updated Specifications of Supplier Raw Materials and Packaging Components.

Authored or Approved Deviations and Document Change Revisions.

Approved Supplier and Service Vendors.

Conducted Internal Departmental Audits.

Reviewed Analytical and Microbial Reports.

Approved Equipment Protocols and Calibration Reports.

Supervised log control of CAPA's, Document Change Requests. Deviations, Lab Investigations, CofA's.

Provided cGMP and SOP training, supervise maintenance of training records.

Communicated effectively with Third Party vendors as necessary to establish/clarify compliance and manage priority.

Travel to Third Party Vendor sites and lead as the Quality representative and during cross functional meetings

Negotiated and established Quality Agreements with Suppliers and Contractors to fulfill regulatory requirements

Initiate and maintain Vendor qualification audits/communication

Ensured all products are manufactured in line with all legislative obligations and ensuring the safety, quality and efficacy of the product prior to final release to market.

Provided expertise in writing or reviewing both operational and Quality SOPs.

Lead root cause analysis investigations on product and process deviations.

Provided quality oversight of the CAPA program/methodology.

Performed high level review of product and process changes especially where there are implications for patient safety, quality and compliance. Apply interpretation of regulatory and quality requirements to provide assurance of appropriate science and risk based assessments. Routinely make decisions with significant monetary impact.

Provided leadership through the knowledge of CFR 21 Good Manufacturing Practices and technical trends

Logged in complaints from Intake vendor in Trackwise, Communicate with Contract Suppliers Inspect return samples,

Global Leader Consumer Healthcare Products, OTC Pharmaceutical Manufacture

Contract

Pharmaceutical manufacturer.

Third party CMC Specialist.

Generic Pharmaceuticals-Product Investigations

Contract

Quality Assurance Clinical Packaging and Logistics Manager

Directed PAI pharmaceutical project initiatives and improvements. Managed Document Control and Quality Systems such as Complaints.

Supervised QA Inspection and QA Release Auditing staff. Created and implemented an Internal Appraisal/Audit System. Authored and approved Investigations, Change Controls, SOP’s and Material Safety Data sheets.

Reviewed label and package design. Conducted Site Lot Jacket Auditing System (Production & QC) and Lot Disposition.

Developed Quality Investigation Control system and CAPA

Guaranteed successful Regulatory Agency (FDA, MHRA) visits by establishing compliant APR system

Review System and offering useful recommendations and alerts for maintaining Specification compliance.

Fulfilled FDA requirements by creating Customer Complaint System and Document Control System.

Prevented regulatory non-compliance by hosting FDA inspections and authoring responses to observations.

Reviewed and commented on Stability protocols providing justification support in establishing specifications

Minimized deviations due to unorganized planning by authoring Contract Giver - Contract Vendor Quality Agreements and establishing system for clearly outlined Operations and Quality responsibilities.

Coordinated Vendor Quality Assurance lot jacket review leading to expedited approval of product.

Ensured equipment, qualification/operations robustness and expedited approvals of investigations, SOP’s and other routed documents by interviewing and selecting Validation and Document Control Vendors.

• Supervised and trained Pharmaceutical Product Assurance and New Products Quality Assurance groups on prioritization and compilation of individual manufacturing and packaging lot record information. Submitted final lot Disposition, produced Certificate of Analysis documents. Reviewed and approved Master Production Orders, Formulation Orders and Fill Label Pack sheets.

• Conducted vendor and site auditing. Reviewed and approved Validation Protocols Lead in Pre-approval readiness for upcoming Regulatory agency inspections (PAI).

• Led QA in Product Process pilot plant size trials and commercial scale up lots leading to PAI

• Project Lead of Pre-Approval Inspection preparation readiness meetings.

• Reviewed New Drug Application and Material Application drafts prior to filing.

• Ensured timely batch review by maintaining status communication with production supervisor or project scientist.

• Reviewed and approved Annual Product Reviews

• Lot disposition in SAP and Trackwise,

• Trained interdepartmental staff on updated SOP’s and CGMPs

• Ensured regulatory guidelines compliance by approving Quality Investigations and assigning CAPA in Trackwise.

• Championed and communicated site updates needed for establishing specifications and internal action level limits for Product Process Development projects

• Negotiated and established Quality Agreements with Suppliers and Contractors to fulfill regulatory requirements.

• Reduced cycle turnaround 25% by managing metrics of lot disposition commitment schedule against quality receipt of production/packaging lot records and supplementary documents.