Quality Assurance Medical Device

AFRA ANANE

**** ****** ***** ****: 561-***-****

Wellington, FL 33414 *******@****.***

PROFILE

Experienced Scientific Professional with 12+ years of experience in

regulatory, compliance and quality assurance in the Medical

Device/Pharmaceutical, In-vitro Diagnostics and Blood Banking industries.

Able to influence and communicate across all functional groups and levels.

Expert in Customer Complaint Handling, Medical Device Reporting with

quality, regulatory, and compliance background. Strategic thinker,

effective trainer, good communication skills with a passion to strong

focused on driving customer and product values. Excellent writing and

interpretation of complex processes and requirements, detail oriented with

strong organizational skills. Highly motivated self-starter eager to learn

and proactively seek new challenges. Assumes personal ownership and

accountability for business results and solutions. Expertise includes:

Detail oriented with strong organizational skills

Validation Process Quality/Regulatory/Complianc

CAPA e Skills

cGMP Process Improvement

Medical Device Reporting Complaint Trend Reporting

Complaint Investigations Process Excellence Kiazan

Internal & External Risk management

Auditing

GDP

PROFESSIONAL EXPERIENCE

ONEBLOOD, INC., Lauderhill, FL

2012- 2013

Quality Assurance Program Manager

Responsible for facilitating the interpretation and implementation of

quality and regulatory requirements to ensure compliance. Coordinated

regulatory affairs activities to ensure appropriate filing and registration

activities are complete. Served as a resource for departments in accordance

with regulatory agency requirements and organizational policies and

procedures.

. Ensured corporate compliance by hosting external assessments and

inspections conducted by agencies with regulatory or accreditation

authority (FDA, AABB, CAP).

. Facilitated and monitored process change management to maintain

compliance with quality standards by evaluating impact and risk to

related processes prior to implementation of changes

. Conducted comprehensive and focused internal audits to ensure compliance

with established internal, corporate, and regulatory requirements and

provided findings and recommendations to senior management and affected

departments.

. Represented Quality Assurance to support development projects, as

necessary, to ensure proper design control practices were utilized.

. Due to expertise was selected by management to collaborate with various

departments to conduct risk assessments to determine the risk level and

the proper qualifications of critical equipment and processes.

. Designated to write, implement and train all staff and management on the

Equipment Qualification Process which ensured all departments were

incompliance and aligned with the process.

. In response to customer complaints and external audit findings, was

selected as a process improvement expert to investigate, identify root

cause and facilitate the implementation of corrective and preventative

actions.

MICRO TYPING SYSTEMS, INC., Pompano Beach, FL 2004- 2010

an Ortho-Clinical Diagnostics Company (Johnson & Johnson)

MTS Product Vigilance is the designated Complaint Handling Unit for

products manufactured and/or distributed by MTS including finished product,

disposables, instruments and Software / firmware.

Senior Customer Quality Scientist (2004 - 2010)

Ensured product complaints were evaluated, investigated, reviewed, and

documented.

. Resolved customer complaints regarding product quality issues by

initiating Failure Investigations, which identified root causes and

recommended corrective and preventative actions related to those

complaints.

. Conducted and led monthly complaint review meetings including preparation

of trend reports, analysis of complaint levels exceeding alert limits and

completion of monthly trending.

. Provided troubleshooting advice to Customer Technical Service staff

related to transfusion medicine products, which facilitated in the

expediency of the investigation.

. Significantly reduced liability to the organization by preparing,

escalating and providing recommendations of quality issues to cross-

functional senior management team, business partners and suppliers for

awareness and to determine appropriate action to be taken.

. Improved the Customer Complaint Handling Process by streamlining the

complaint management system to create a robust, efficient process and to

be in a global alignment with the Complaint Handling Unit.

. Successfully led cross-functional team on Process Excellence Kaizen event

to lean Quality Control Laboratory by restructuring the lab and

eliminating non-value added tasks.

. Conducted Health Hazard Evaluation s (HHE), participated in Risk

Management, Recalls and Post-Market Surveillance (PMS) processes, as

required to ensure compliance with established internal, corporate, and

regulatory requirements.

. Successfully took on additional responsibilities such as training and

providing relevant information to management as a subject matter expert

during company down sizing.

. Continuously achieved and exceeded company goals for Medical Device

Regulatory Reporting to the Food and Drug Administration.

. Successfully worked with business partners in maintaining and improving

quality management systems to create robust, efficient processes and to

facilitate overall compliance with all national regulations such as the

US Quality System Regulations (QSR) under 21 CFR Parts 803, 806, 820 as

well as ISO 13485, and ISO 14971.

Serologist (1998 - 2004)

Ortho-Clinical Diagnostics Company (Johnson & Johnson)

. Conducted quality control functions such as product inspections, quality

control serological in-process testing, investigations and final lot

release testing on Transfusion Medicine product reagents to the ensure

the safety, purity, quality and potency prior to product release and

distribution.

. Designated to write, implement, and train on departmental procedures,

which ensured all personnel were in compliance and aligned with the

serological process.

. Assisted the Product Support department in conducting investigations, new

products introduction, product transfers, validations, and process

improvements to meet goals and deadlines.

. Performed serological evaluation of biological raw materials and

determination of dilution factors for Antisera Reagent formulations

through in-process serological assays and Monoclonal and Polyclonal

reagents to provide assurance of the safety and effectiveness of

serological reagents.

. Trained designated personnel in Assay, Processing, and Departmental

Procedures.

. Conducted in-process and batch record review of quality documents to

ensure good documentation and manufacturing practices.

EDUCATION

Bachelor of Science (BS), Medical Technology

Kean University, Union, NJ

Associate of Science (AS), Biology

Raritan Valley Community College, North Branch, NJ

TECHNICAL TRAINING

Computer Skills: Windows Office Suite; Word . Excel . PowerPoint .

Microsoft Outlook . Visio .Trackwise .Pilgrim

PROFESSIONAL CERTIFICATION

Medical Technology (ASCP eligible)

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