Quality Specialist Ii

****************@*****.*** 803-***-**** Batesburg, USA 29006

PROFESSIONAL SUMMARY

Focused Quality Specialist that delivers consistent and professional work for every assignment. Offers 6 + years in the pharmaceutical industry environment with top-notch dedication to quality and accuracy. Familiar with handling multiple projects in highly competitive environments. Solid interpersonal and collaboration skills.

WORK HISTORY

Quality Specialist II. Remote

Actalent/Gilead Sciences 01/2023 - Current

Reviewed production processes and identified potential quality issues.

Completed supporting documentation for testing procedures, data capture forms, equipment logbooks and inventory forms.

Conducted data review and followed standard practices to find solutions.

Completed independent data review of forms and batch records.

Calculated batch records for final batch weight, needed volume, simple metric conversions and raw materials measured.

Performs a wide variety of activities to ensure compliance with applicable regulatory requirements.

Maintains routine programs and processes to ensure high quality products and compliance with current Good Manufacturing Practices (GMPs) and Good Laboratory Practices GLPs).

Interfaces with contract manufacturers to address documentation and compliance issues.

Wrote and approved minor deviations in TrackWise.

Worked with CMO's nationally and internationally.

Applications used, Veeva Vault, Grasp Crystal, SAP ERP, SharePoint, Oracle EBS, Lims, IQS, QMS, Box, Microsoft 365 and Adobe Acrobat Pro.

Quality Assurance/Batch Record Review

Nephron Pharmaceutical 01/2018 - 12/2022

Reviewed/Approved for final release of batch records for completeness, accuracy and compliance with cGMP regulations.

Processed requests for information and released information to persons or agencies according to regulations.

Maintained continuity of work operations with documentation and communication of actions, irregularities and continuing needs.

Identified incomplete records and independently pursued missing information.

Making sure all guidelines and standards have been met for the FDA and DEA for compliance for Schedule II and Schedule III drugs.

Identified issues and implemented prompt and successful solutions to eliminate backlog and maximize workflows.

Collaborated positively with peers and other staff members to maintain friendly, supportive and cooperative work atmosphere.

Verified facts, dates and statistics through our Standing Operating Procedures.

Working with paper records and Electronic Batch Records (EBR) for all pharmaceutical products within our company.

Review/Approved final release of CMO batch records for Covid Testing for release.

Verified/Approved all testing information and results for Microbiology and Chemistry are in cGMP compliance.

Image Process Supervisor

WSP/Parson Brickerhoff 08/2017 - 12/2018

Elevated team performance against objectives by helping train new team members.

Improved team performance by providing direction and hands-on support.

Strengthened team performance with continuous training strategies

Tracked employee performance to determine areas of strength and improvement.

Focused employees on important tasks and prioritized work actions to accomplish daily goals.

Ensure smooth operations by assisting the manager with Image Processing duties.

Continuously setting objectives, assessing progress and provide on-going coaching and feedback.

SKILLS

Strong communication

High rate of accuracy

Highly motivated

Multi-tasking and work prioritization

Reliability

Computer Proficiency

Documentation skills

Time management abilities

Regulatory Compliance

Communication Skills

Batch Record Review

Detailed documentation review

Quality review

EDUCATION

Grantham University

Kansas City, MO

10/2019

Master's: Business Administration

Grantham University

Kansas City, MO

07/2016

Bachelor's: Health Systems Management

Michelle McCormick

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