Amy L. Berley

ace1hn@r.postjobfree.com

*** ******** ***** . ********* *******, OH 44147 . 858-***-****

Qualifications Summary

Quality Systems Coordinator with 10 years experience in the

CMO/Biotechnology/Pharmaceutical industry. Working knowledge of 21 CFR 820-

Quality System Regulation and ISO 13485. Well versed in the varying

aspects of the document control process; maintain GMP documents,

handle/process document change requests, technical transfer documents,

update document files and create master and working files. Enthusiastic,

quick study, diligent in attention to detail and execution of assigned

tasks in a timely manner.

Work Experience

OrthoHelix Surgical Designs, Inc.

Medina, OH

Quality Systems Coordinator (Apr. 2012-Current)

Well versed in the varying aspects of the document control process;

maintain controlled documents, handle/process document change requests,

update document files and create master and working files

. Implement and maintain required quality records, systems and

procedures

. Provide first level support of the change control (QSPs, forms,

policies) program, including creation, revision, review and approval

. Scan all necessary Quality documents; save, store and retrieve

. Update excel spreadsheets, databases and manuals

. Maintain filing of all master documents and Quality correspondence

files

. Format, revise, number and track controlled documents

. Review documents submissions; working with authors to ensure correct

formatting appropriate reference prior to routing documents for review

. Ensure proper security access and maintenance of controlled documents

. Stays abreast of current regulations and guidelines directing document

control

OrthoHelix Surgical Designs, Inc.

Medina, OH

HCP Compliance Coordinator (Jan. 2011-Apr. 2012)

Primary responsibility is managing the day to day tasks associated with

Health Care Professional compliance activities, needs assessment reporting

and Quality Document Control.

. Assist in HCP Compliance Program establishment, implementation, and

monitoring.

. Establish, monitor, and maintain compliance risk and needs assessment

documentation.

. Assist in establishing and maintaining compliance policies and

procedures.

. Provide administrative support to other departments within the

organization pertaining to Compliance needs. Support includes

contract administration, interaction with HCP activity reporting,

filing and tracking of legal contracts and documents, and maintained

appropriate reference materials. Dealt with highly sensitive and

confidential material related to legal matters.

. Reviewed and audited Quality System Procedures regularly to ensure all

policies and procedures are being followed.

. Responsible for updating and maintaining all quality records

pertaining to the Quality System Procedures.

. Responsible for updating and maintaining the patent and trademark

databases.

Althea Technologies Inc. San Diego, CA

Senior Document Control Associate (Oct. 2009-Aug.

2010)

Primary responsibility is to work closely with the document controller,

clients, and project management to ensure timely processing of client

specific batch production records.

. Work with Project Managers to create email approval template system sent

to clients

. Completing Technical Transfer Document to initiate a part number and lot

number for Project Managers

. Internal/External liaison with document authors, reviewers, and clients.

. Ensure proper security access and maintenance of controlled documents

. Implement and maintain required quality records, systems and procedures

. Provide first level support of the change control (documents, SOPs,

forms, protocols, and reports) program, including creation, revision,

review and approval

. Scan all necessary Quality documents; save, store and retrieve

. Update excel spreadsheets, databases and manuals

. Maintain filing of all master documents and Quality correspondence files

. Format, revise, number and track controlled documents

Documentation Control Associate (Dec. 2007-

Oct. 2009)

Primary responsibilities were generating, maintaining, issuing,

distributing and tracking all electronic and hard-copy controlled documents

and maintaining associated logs in accordance with the appropriate

regulatory agency requirements to support a cGMP manufacturing facility.

. Maintain Excel spreadsheets utilized in tracking relevant information

such as client contact information and completed project dates for all

batch records.

. Managing/Upgrading master document lists and executing the Biennial

Review of all Standard Operating Procedures

. Preparing, maintaining, and distributing approved control document

electronic template for master production records, standard operating

procedures, test methods, validation protocols/reports, material

specifications, and other cGMP documentation as required

. Receiving/Processing change requests for new documents and revising

existing documents

. Reviewing document submissions; working with authors to ensure correct

formatting and appropriate referencing prior to routing documents for

review

. Work with Project Managers and clients routing documents for review and

approval; tracking of review and approval process according to document

priorities

Quality Assurance Assistant (June 2004-Dec. 2007)

Primary responsibilities were issuing or approving, effective controlled

documents; maintaining and auditing of controlled document binders to

ensure placement of current effective documents and removal of superseded

versions.

. Issuing and tracking laboratory notebooks and logbooks for every

laboratory

. Receiving and logging in QC samples received

. Performed line clearances, AQL and vial inspection on final product

. Performed magnehelic gauge readings in the cGMP areas

MicroConstants Inc. San Diego, CA

Administrative Assistant / Document Control Coordinator (Jan. 2003-June

2004)

. Responsibilities included preparation of laboratory notebooks,

coordination of entire purchasing/receiving inventory.

. Updated all Quality Assurance logs, SOPs and preparation of client past

due letters and sample discrepancy/disposal letters.

. Responsible for preparation and examination of patient kits and

performing phlebotomy.

. Communicated on a daily basis with analytical scientists, managed and

relayed their needs for equipment and documentation.

. Handled inbound calls, including customer service and client relations.

Scripps Clinic Rancho Bernardo, CA

Certified Medical Assistant (May 2002-Dec.

2002)

Welcoming patients and coordinating room scheduling

Checking vital signs, performing phlebotomy, taking urinalysis tests and

assisting the physician during surgical procedures

Organizing patient/family history files

Providence Hospital Anchorage, AK

Certified Medical Assistant, OBGYN Department (Jan. 2001-Jan.

2002)

. Responsibilities included checking vital signs and assisting with

procedures.

Relevant Skills

Proficient in Word, Outlook, Excel, Power Point, Access, ACT! Adobe

Acrobat, and Medical Manager. Attended and received a certification in

Word I, Word II, Excel I and Time Management. Certified Medical Assistant,

Adult/Child CPR and First Aid. AFFA (Aerobics and Fitness Association of

America) Certified Personal Trainer.

Education

University of Alaska Anchorage (2000-2002) Anchorage, AK

Associates of Applied Science

Ferris State University (1994-1995) Big Rapids, MI

Health Science Program

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