Roxanne Hardy

603-***-****

ad1lsu@r.postjobfree.com

Albany Molecular Research, Inc

Quality Assurance Specialist I – Document Control -September 2019 – Present

Responsible for the processing, formatting, obtaining approvals, mastering, distribution and archival of Standard operating Procedures, Forms, Batch Records, Protocols, Material Specifications. Send GMP documents to the clients for their review and approval.

Authors and revises the Standard Operating Procedures

Assists in developing and delivering cGMP training

Provide support to manufacturing and QA operations

Participate in document identification, development revision, review, approval and distribution of new or revised documents

Assign DCN numbers, track and process through closure

Responsible for logbook and lab notebook issuing, tracking and reconciliation

Creates official copies of the master batch records, assembles and verifies executable batch records

Generates, issues and verifies QC labels

Reviews executed documents prior to sending to clients and archival

Facilitates the orderly storage and retrieval of documents, ensuring movement of documents and records in and out of the archive is controlled and documented

Interacts with various personnel from all departments in activities listed above

Provides audit support for client, internal and regulatory audits

Assists in performing investigations

Performs internal audits and weekly walkthroughs

Assists in developing and delivering training

Develops and/or maintains Quality System metrics for Management Review

Proficient in the area of document control and familiarized with current regulations and cGMP’s

VistaPharm A VerticePharma Via, HumanEdge A Contract Agency

Document Control -July 2017 to September 2019

Maintains the Document Change Request (DCR) System in accordance with department SOP’s:

Reviews submitted DCR Forms and initiates the DCR review process

Coordinates the review process by tracking DCR’s from opening to release

Coordinates the implementation of changes

Notifies, copies, and distributes documents internally.

Maintains revision history of documents within the Documentation Database system. Maintains computer files as well as paper files for the document system. Maintains the Part # Log, DCR # Log, and DCR Database.

Logs and Issues controlled copies of production records to manufacturing.

Provides copies of released documents as required upon request.

Documentation Review:

Assists in the review of Batch Records (BRD’s) prior to product release

Issues and assigns laboratory notebooks.

Participates in additional projects as assigned by supervisor/manager.

Supports personnel associated with document control to provide documentation support to all areas of the plant for SOP's, specifications, and batch records.

Supports Change Control processes to assure conformance with requirements and maintenance of records associated with change control activities.

Support the Training System.

DUSA Pharmaceuticals, Inc. A Sun Pharma Company

Quality Assurance Specialist March 2009-July 2017

Responsible for providing Quality Assurance support to Manufacturing Operations relative to the production of commercial and /or clinical products.

Responsible for a diverse and challenging set of activities, all of which are related to maintaining quality standards aligned with US, FDA, cGMP, QSR, ISO and other applicable international regulations and guidance documents.

Perform incoming inspections on components and raw material: send samples to external testing labs.

Perform complaint investigations on both drug and divece through analyzing returns and reviewing batch records.

Provide written reports of findings.

Maintain the Calibration program, distributes monthly calibration reports and send items to external calibration sources.

Maintain the CAPA program, manage monthly CAPA meetings and distributes minutes from the meeting.

Conduct environmental monitoring sampling & testing. Participate in compliance audits (internal and external) and correct deficiencies as required through the appropriate system.

I am the go to person for Documentation Control when the Documentation Control Specialist is out.

Support manufacturing for all clinical trials including return of clinical trial materials according to regulations and internal SOPs.

Perform all principle duties that affect the quality of products and services provided by DUSA Pharmaceuticals Inc. within the guidelines of 21CFR 210/211, 21 CFR 820, ISO 13485, the Canadian Medical Devices Regulation (CMDR), Medical Device Directive (MDD) and other applicable standards, laws and regulations wherever we do business.

ConforMIS

Quality Lead, Weekend Shift December 2014-July 2017

Responsible for the quality inspection / quality assurance / lot release activities for weekend operations, including interpretation and implementation of quality standards to routine inspection/testing and manufacturing activities, as well as applying a wide range of metrology skills.

Provide direction and mentorship to junior Quality personal to meet production, departmental and training requirements.

Supervise Quality Inspectors for daily activities.

Schedule daily activities for Quality Inspectors.

Provide training and mentorship on a daily basis.

Conduct incoming, in-process and final product inspections per procedures.

Inspect, sample and perform physical/visual inspections on components.

Initiate and participate in resolution of non-conforming materials.

Initiate non-conforming material reports as required.

Maintain inspection files, Review and maintain Device History Records.

Operate Optical Comparator.

Statistical Process Control.

Responsible for final product release sign off.

Verify printed labeling, assist in resolving quality problems.

Assist in corrective action investigations.

Identify potential non-compliances/improvements in the inspection/manufacturing area and initiate document change orders as required.

Assist in maintenance of the calibration system.

LAL testing

Post sterilization (Ethylene Oxide/Vaporized Hydrogen Peroxide) inspection

Creating and implementing DCO’s

LNX Corporation, Salem NH.

Quality Technician March 2008-March 2009

Responsibilities include all aspects of Quality Control, In Process, Incoming and Final Inspection.

Maintained stock room.

Corfin Industries, Salem NH.

Quality Technician December 2007-March 2008

Preformed Quality System Internal and ESD Audits, solder analysis, outside calibration services.

Material controls, test equipment controls including Fine and Gross leak detectors.

Maintained procedural training records also coordinated training schedules.

Completed software back-ups of all robotic equipment.

Point of contact and back up for the QA Manager.

Media, Bedford Ma.

Quality Management Senior Inspector June 2006-December 2007

Preformed in-process/final inspection and testing of blood gas pumps and accessories.

TSA, Manchester Airport, Manchester NH.

TSA Agent July 2005-June 2006

Screened passengers and all baggage boarding commercial flights.

Trained in checked luggage as well via Manchester Airport.

Andrew Corporation Amesbury, Ma.

Group Leader – Manufacturing Manager Assistant April 2005-July 2006

Support the manager in overseeing a production group of approximately 100 people, 5 production lines in a lean manufacturing environment using continuous work flow concepts.

Assist with scheduling of work flow as well as troubleshooting.

Responsible for successful interviewing, hiring, and training of new employees.

Responsible for preparation of performance reviews, time card control, and employee terminations.

Attended production meetings and maintained inventory control across all departments.

Coordinated with the purchasing group in order to expedite parts for use in production process.

Baxter Andover Ma.

Quality Management Senior Inspector December 1995-March 2005

Responsible for administering and coordinating work flow.

Responsible for training of inspectors and evaluating workers performances.

Responsible for writing inspection and test procedures.

Maintain accurate and complete history and master files for FDA /GDP Regulations.

Maintain accurate and complete history and Master files for FDA /GMP trace ability.

Assist in creating and maintaining department-operating procedures.

Quality Representative for the startup of new product.

Steinbrecher (VIA B&MASSOC.)

Senior Quality Inspector June 1995- December 1995

Preformed inspection on surface mount PC Boards, ISO-9000 certified.

Preformed first piece inspection, incoming and final inspection.

Megapulse Corp. (VIA B&MASSOC.)

Inspector June 1992-June 1995

Perform first piece inspection, in process inspection, and machine shop fabrication inspection, both visual and dimensional on ridged and flexible single and multilayered circuit panels and cables.

Raytheon, Andover Ma.

Inspector January 1987- October 1991

Responsible for reliably inspecting all phases of the antenna element for the Patriot Missile’s Radar System.

Responsible for the testing and inspecting of computer boards for both the Patriot and Hawk Missiles.

Visual Technology, Lowell Ma.

Supervisor July 1984 - May 1987

Supervised up to 50 employees in the assembly, inspection, wave solder, touch- up and debug departments.

Responsibilities included, successful interviewing, hiring, and training of new employees, preparation of performance reviews, time card control, and employee terminations.

Attended production meetings and maintained inventory control across all departments.

Responsible for purchasing of all supplies to maintain departmental functions.

References furnished upon request.

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