Quality Assurance Control

Certification

Six Sigma Yellow Belt

****

Alana Rico

Quality Assurance Annual Product Specialist

Focused and driven Quality Assurance Document Specialist with over 13+ years’ experience in Pharmaceutical and Medical Device regulatory environment with strong leadership, excellent customer relations skills, and an ongoing commitment to professionalism. Skilled in working effectively in collaborative and self-motivated environments. Core Competencies in:

Document Control - Documentation Writing - FDA Filings - Stability Reports - Stability Commitment and Protocols - Certificate of Analysis - Statistical Trending - Project Management - Quality Assurance/Quality Control Plans and Strategies - Continuous Quality Improvement - Standard Operating Procedures - Work Instructions - HIPAA, FDA, DEA and cGMP regulations - CAPA - Business Relationships Document Summaries:

Provided and tracked for each APR in QSDB. Verification of all active bulk batches and packaged item numbers from Record MMF(s), MPS(s) and T-spec. Perform and print SAP transactions – CS15, CS03, and MB51. Verify all information in QSDB Classic are on each tab in QSDB Classic. Work History

2021-02 -

Current

Quality Assurance - APR Specialist

Hikma Pharmaceuticals

Author and Reviewer of Annual Product Reports (APRs) for management review in compliance with Good

Manufacturing Practice for Finished Pharmaceuticals, 21 CFR Part 211.

Training new employees on the APR process.

APRs include the APR Summary conclusion, all Batch Manufactured/Released Information, Deviations,

Complaints, Rejections, QC Release & Stability Results, Retention Summary, Field Alerts and/or Recalls.

Contact

Phone

614-***-****

E-mail

********@*****.***

Regulations

21 CFR Part 211

cGMP

HIPAA

DEA

Enterprise Apps

and Platforms

SAP

LabWare

Minitab

TrackWise

QSDB

QSDB Classic

DocuSign

Veeva Document

Management

System

MS Office Suite

2017-08 -

2020-02

Key Achievements

• High percentage of on time completion rate

of APRs due to current limited capacity.

• Participant and one of the presenters of the

Risk Assessment Quality Team meeting.

Responsible for providing RA meeting notes to

the team and including in the APR

• Six Sigma Yellow Belt Certification

Quality Assurance - Document Specialist I

Hikma Pharmaceuticals

Responsible for supporting FDA filings through

documentation generation through multiple Certificate of Analysis requests, Stability Reports for Drug

Regulatory Affairs, and Stability Commitment and

Protocols.

Provide Annual Statistical Trending Reviews to Quality Assurance and staff.

Collaborator in generating and routing specifications and analytical procedures.

2015-11 -

2017-08

Quality Assurance Complaints Specialist I

Boehringer Ingelheim Pharmaceutical Inc.

Responsible for product complaint investigations,

investigating and documenting in TrackWise system, identifying appropriate Corrective Action –

Preventative Actions (CAPA), manage complaints to

meet Quality Assurance Agreement policies,

evaluating data trends and providing

recommendations for continuous improvement.

Key Achievements:

Continuous Improvement - created SOP of How to

handle Delayed Complaints

Continuous Improvement - Manage and Triage Quality Assurance Complaint Service Mailbox

Awards

Neuronetics, Inc.

2014 Outstanding

Performance Award

2011-10 -

2015-05

Senior Customer Service Representative

Neuronetics, Inc. (Medical Device Company)

Bullet Overview of function:

• Lead Customer Service Team of 3

• Document, review, and assign; escalated issues,

medical cases, physician/patient inquiries, and

technical complaints

• Reviewed/Updated Departmental SOPs to maintain

current quality guidelines

• Department Project Lead for cross-functional

projects related but not limited to; Quality and

Product Development

• Department Audit POC for Quality

• Department Lead for onboarding new employees

• Create sales and complaint reports for data

analysis

2011-01 -

2011-08

Project Administrator

The Garden City Group

Bullet Overview of function:

• Review and resolve issues presented by Quality

Assurance

• Create case specific audits/reports

• Process new electronically filed claims, analyze files, and input into database

• Handle calls and emails from institutions with

general questions

• Review broker statements, trade confirms and

affidavits

2009-12 -

2011-01

Quality Assurance Complaints Specialist I

Boehringer Ingelheim Roxane Inc. (Pharmaceutical)

Bullet Overview of function:

• Track complaint product returns daily

• Updated Complaints Database

• Perform investigations on product complaint

samples, desk evaluations and laboratory

investigations

• Closed completed product investigations/records

• Inbound and outbound communications to:

consumers, clinics, pharmacies, hospitals, and

wholesalers regarding product complaints

• DEA Training and Compliance

Education

Columbus State Community College

Associate of Science (In Progress)

References

**References available upon request**

Contact this candidate