Hayat Adem
Clarksburg,MD
Summary
I have over7 years of customer service experience and a strong background in manufacturing, quality assurance document control, and sales. My professional journey at GSK, coupled with biopharma manufacturing expertise, has honed my readiness and adaptability skills.Developed strong organizational and analytical skills in fast-paced, detail-oriented environment. My passion for helping people and delivering results makes me an asset to any organization
Overview
15
15
years of professional experience
1
1
Certification
Work History
Quality Assurance Document Control Specialist
GlaxoSmithKline, GSK
04.2022 - Current
- Reviewing batch records before and after process to ensure good documentation completeness and compliance to cGMPs outlined by global regulations and internal site procedures
- Responsible for storage and archival of GMP documents and batch records
- Perform tasks in a manner consistent with the safety policies, quality system and GMP requirements
- Review and approve SOPs and all other documentation
- Process, circulate, review and catalog documents and approvals
- Drive continuous improvement for more efficient work
- Coordinated with cross-functional teams to support document management and review
- Coordinate with both sites (large scale and small scale) for any GMP and non GMP documentation needs
- Become proficient in the following internal systems and activities: SOP’s, Change Controls, Deviations, Corrective Actions, Training records, and record retention
- Provide support during inspections and audits
- Coordinate with site offsite storage to maintain proper retention of all documentation
Biopharmaceutical Manufacturing
GlaxoSmithKline Pharmaceuticals
04.2022 - 04.2023
- Perform sampling procedures on various analytical instruments to analyze cell culture, solution and/or product concentration characteristics. Operate filter integrity devices to confirm the integrity of filters pre and post use.
- Preparation, cleaning, sterilization, batching, pasteurization or filtration and delivery of media and solutions for cell culture and purification operations.
- Set-up fixed and mobile process equipment and parts with CIP skids to carry out validated cleaning and sterilization process.
- Follow appropriate standard operating procedure (SOPs), protocols and batch records/logbooks to safely perform process operations and document compliantly with good documentation and data integrity practices.
- Follow all related safety policies and procedures and put safety first by playing an active role in identifying and correcting unsafe behaviors and conditions.
- Execute manufacturing processing steps and /or manufacturing support activities, monitoring the process against the batch record and control system and documentation.
- Document/Record and review cGMP data and information for processing steps and/or equipment's activities, following standard operating procedure.
- Actively participate in training activities , managing their individual training plan.
Sales Manager
Gibson Import and Export
12.2017 - 11.2020
- Served as sales manager with responsibilities such as tracking inventory and training new employees
- Trained over10 employees
- Provided enjoyable customer service in a fast-paced work environment
- Communicated with other sales managers and vendors regularly to avoid stock outs
- Worked with5 vendors per week
English Teacher
English Teacher
04.2016 - 07.2016
- Taught English language to Kindergarteners
Data Entry Operator, Construction Supply Store
FANELA INTERNATIONAL P.L.C
03.2010 - 12.2014
- Cataloged, organized and entered data in Excel inventory
- Used a POS system to sell construction supplies and collect payments
Education
Help Desk Professional -
Career Technical Institute
06.2021
Bachelor of Arts - Marketing Management
Addis Ababa University
05.2013
Skills
- Customer service
- Microsoft Office skills (Word, Excel, PowerPoint, Visio)
- Data entry
- Document formatting and preparation
- PDF creation and editing (Adobe Acrobat)
- Bilingual (English, Amharic, Arabic, and Mandarin)
- Leadership, adaptability, and teamwork
- Auditing documents
- Document management
- Document review
- Archiving procedures
- Records management
- Document organization
- Document retrieval
- Proficiency in SAP
- Teamwork and collaboration
- Attention to detail
Certification
- Certification on Basic Mandarin
- Certification on Basic Digital Literacy
Activities
Literature Environmental conservation Art Yoga Skiing Travel
Timeline
Biopharmaceutical Manufacturing
GlaxoSmithKline Pharmaceuticals
04.2022 - 04.2023
Quality Assurance Document Control Specialist
GlaxoSmithKline, GSK
04.2022 - Current
Sales Manager
Gibson Import and Export
12.2017 - 11.2020
English Teacher
English Teacher
04.2016 - 07.2016
Data Entry Operator, Construction Supply Store
FANELA INTERNATIONAL P.L.C
03.2010 - 12.2014
Bachelor of Arts - Marketing Management
Addis Ababa University
- Certification on Basic Mandarin
- Certification on Basic Digital Literacy
Help Desk Professional -
Career Technical Institute
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