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Control Analyst Quality Assurance

Location:
Woodlawn, MD, 21207
Salary:
$102,710.58
Posted:
April 10, 2022

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Resume:

Anissa C. Easter, B.S

**** ******** ***.

Baltimore, Maryland 21206

804-***-**** mobile

adqqs5@r.postjobfree.com

LinkedIn: adqqs5@r.postjobfree.com

PROFESSIONAL PROFILE

Quality Control Analyst/Quality Assurance Specialist with twenty-two years of significant experience in the Biotechnology/ pharmaceutical industry. Areas of expertise include my ability to train fellow team members, learn new scientific and technological skills, and motivate and contribute in a team environment. Applies broad knowledge of chemistry and microbiology disciplines into the work environment.

PROFESSIONAL EXPERIENCE

Altimmune, Inc. Sr. QA specialist Nov. 2020 to present

Managing lot review activities for clinical material/products to ensure disposition timelines are met.

Reviewing and managing deviations from contractors related to manufacturing and testing.

Reviewing executed batch production records to ensure compliance with approved procedures, quality agreements and GMP/GLP expectations.

Communicating and managing lot files.

Compiling and managing lot files.

Assisting in the preparation, execution, report and follow-up of internal and external audits.

Participating in quality system improvements.

Monitoring project progress to ensure efficient and effective communication on project status and issues.

Authoring, reviewing and revising site SOPs to ensure compliance with GDPs, regulatory requirements and corporate standards.

Performing other duties as assigned by Quality Management.

GlaxoSmithKline, GSK, Manufacturing Investigator Specialist Oct. 2019 to Oct. 2020

Lead cross functional deviation investigations, performing root cause analysis (RCAs), assessing product impact and developing corrective and preventive actions (CAPAs).

Utilizing production control systems including Delta-V, CCDARTS, Unicorn and M-ERP.

Collaborating with QA, Biopharmaceutical manufacturing (BPT) and process science subject matter experts (SMEs) to monitor critical process parameters and ensure product quality.

Conduct data gathering, trending, and data presentation to support investigations and continuous improvement processes.

Managing stakeholders, quality records, and ensuring on-time deviation closures of investigations to ensure product batch release.

Lonza, Walkersville, Md. July 2019 to Oct. 2019

Quality Assurance Specialist III for Cell Therapy (CT)

Batch record (BR) review

Environmental monitoring (EM) review

Deviation review

Aseptic processes

Scanning, filing, archival data retrieval

Other duties as deemed necessary

Shimadzu Scientific Instruments, Inc., Columbia, Md. June 2018 to April 2019

Quality & Regulatory Specialist

Write SOPs, Work Instructions.

Perform customer questionnaires.

Register clinical medical devices with designated regions, and other duties as required.

American Type Culture Collection (ATCC), Gaithersburg, Md. October 2016 – May 2018

Senior Quality Assurance Specialist

Assists with staff training as necessary to help achieve the company’s Quality goals.

Assists with development of standard operating procedures applicable to Quality Systems Regulations.

Performs evaluation of approved production processes, identifies gaps in processes or documentation, validation documentation and other supporting

components that may be required in support of production to support the expansion of ISO 13485:2003 product lines.

Assists with the administration of corrective and preventive action in accordance with standard operating procedures.

Advises internal customers to ensure ISO compliance with product development goals are met according to company’s SOPs.

Functions as a lead auditor in assisting with both internal audits and vendor audits to ensure compliance to documented procedures. Supports the department with resolution and monitoring of any identified action items.

Assists with the preparation and analysis of data for management reviews and monthly metrics. Assists with the implementation of any resultant action items.

Assist with training staff in accordance with quality-related policies and procedures as requested.

Performs other ancillary duties as assigned.

Review monthly line clearance, LN, -80 C, -20 C, +4 C forms for the biorepository.

QA sample inventory, outgoing samples, QA discrepancies and retrieving samples from inventory using the ANSI requirements.

Write Squish reports for the SDLC procedures

Reviewed IQ, OQ, PQ qualifications for all of the equipment in the Biorepository.

Review the CofAs for vendors.

Trained on BSI- Biological Specimen Inventory software

Conduct all the internal audits performed by external audit clients.

Trained on: Guidelines for auditing management systems (ISO 19011:2011), Quality management systems requirements, Quality management systems

Fundamentals and vocabulary in Aug. 2017; and Risk Management for Medical Devices Dec. 2017 and Root Cause Analysis 02 Mar 18.

Aerotek, Rockville, Maryland(Aeras, Rockville, Maryland) July 2014-June 2015

IDT Biologika – Rockville, Rockville, Maryland) June 2015 – October 2016

Quality Assurance Specialist- Perform Quality Assurance reviews of EM data, temperature charts, equipment charts, water records, autoclave data, Batch records, facility logbooks, Gown qualifications, EM trend reports and Water trend reports, BIs and various QC assays. Perform internal audits of various departments. Archival of QC data records. Following the FDA 21 CFR guidelines for CROs. Perform manufacturing duties such as: line clearance, formulation, filling, QC visual inspection, AQL inspections and Release the manufacturing facility. Training involving deviations, investigations and CAPAs. Aseptic gowning procedures/Gown certified.

Project Lead in two manufacturing processes

Good organization and time management skills

Good communication skills to interact and present findings to team members, customers, management and support personnel

Good interpersonal skills for interacting with project and task team members

Good ability to handle activities on multiple projects and tasks within the same or different processes

Ability to work independently with integrity

Ability to work in a team environment

Ability to complete assigned responsibilities in a given timeframe

Ability to deal with and manage change

Ability to participate in various formal and informal professional development training sessions and established quality assurance training

EDUCATION & PROFESSIONAL DEVELOPMENT

BS, Chemistry/Biology (minor), Dept. of Chemistry, Longwood College, Farmville, Va.

TECHNICAL SKILLS

Bioanalysis: cGMP and GLP compliance, Aseptic/Sanitary techniques, Buffer preparation, SDS-PAGE, ALV, ELISA, Ovalbumin, Modified Protein Lowry, Injection Volume, Appearance, Osmolality, Bioburdens, LAL, Microbial plate count, wet chemistry, pH, growth promotion, environmental monitoring, BI, cell culture, plaque, plaque neutralization, Basis RTPCR, Phenol, BCA, Micro BCA, OD280, HPLC, Silver Stain, Western Blots, Titrations, visual inspections and ID testing.

Analytical Technologies: UV/VIS spectrophotometry, Micro centrifuge, Centrifuge, pH unit, Mill flex unit, HPLC, Atomic Absorption (AA), KC-4, Karl Fischer, Gel electrophoresis, Metone unit, SAS unit, Basic skills in GC/MS, analytical balance and TOC.

Computer: Windows, Microsoft Office including Word, Excel, Basic LIMS-Laboratory Information Management Software/Systems (Darwin and Citrix), Aegis, Trackwise, eDOCs, NextDOCs, BSI, Outlook and M-ERP (Manufacturing Enterprise Resource Planning).

Volunteer Activities

Assist and Served the homeless community of Baltimore at the Baltimore Convention Center 2012 to 2014

Alzheimer’s Foundation/Walk 2014 to present

Western Run Community Clean-up day 2015 to 2019 through Chai of JVC.

Good deeds day through JVC feeding lunch to the homeless community of Baltimore 2019

Kidney Foundation/Walk 2019

Share Baby volunteer program sorting baby and toddler clothes for needy families of Baltimore Sept. 2020



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