Quality Assurance Control

Maria Haseeb

North Reading, MA ***** 978-***-**** *******@*********.***

Diligent Quality Assurance Professional with expertise in documentation, production and Inspections in the pharmaceutical, biotechnology and medical device industry. Proven history of providing and reviewing documentation ensuring adherence to quality and regulatory requirements. A strong collaborator with exceptional interpersonal skills. Core competencies:

Quality Assurance Quality Control Compliance Inspection Training Documentations (GMP) Manufacturing Process Food Safety Environmental Testing HR and Administration EXPERIENCE

Medtronic, Billerica MA June 2024 – Present

• Performed visual in process and complete inspections of final catheters using Quality instruction.

• Accepted, rejected defective catheters units based on the Quality instruction criteria.

• Performed work process, equipment testing, manufacturing, disassembly, and reassembly of the catheters.

• Trained new quality control team members on quality inspection process according to Quality instructions.

• Performed the Interim review of the catheter Lot History Record. Pfizer, Andover MA February 2022 – December 2023

Quality Assurance- Documentation Associate (PharmSci) Maintained document metadata, monitored document status and approval notifications, distributed, and archived.

• Assisted with document changes related to CAPAs and change control system (Trackwise, Veeva, eQMS).

• Prepared, reviewed, and approved required documentation, such as Good Manufacturing Practices, Good Laboratory Practices (GLP), Good Clinical Practices (GCP) procedures.

• Worked within the Quality system including usage of Pfizer Document Management System (DMS) to ensure quality and compliance.

• Knowledge of documentation, procedures, and record keeping.

• Knowledge of the documentation lifecycle, including document start, document numbering, issuance, approval, and distribution.

• Knowledge of procedural administration work (staging new documents, new Procedure Change Management staging, staging SOP revision, sending documents for approval, sending documents for review, PharmSci auxiliary document change request, SOP outline format, SOP auxiliary document template, SOP template, procedure processing, business change management, business procedure document template, business procedure auxiliary document template) using the Global Documentation Management System.

• Trained on the Issue Tracker Database for assigning and closing ITD records.

• Experienced in developing and implementing plans for the management of physical and electronic documentation by partnering with the SOP author.

• Partnered with business lines in the development, implementation, and management of their procedures, documentation, and records.

• Ensured that business lines records are transferred to the Active library on schedule.

• Supported the administration of active library and other documentation (e.g., document long-term storage) to maintain proper control of physical and electronic records.

• Inventory management of company records and information within the Central Index of Company Records system to facilitate the development, maintenance, retention, and disposal of company records.

• Collaborated with Pfizer's eRIM (Enterprise Records and Information Management) team to ensure compliance with record retention policies and legal holds.

• Assisted with corporate and regulatory audits.

• Identified gaps and contributed to the review of SOPs. Cross-trained in various aspects of Quality Assurance.

• Understand electronic documentation and database system operations to communicate system flaws to management to improve systems.

• Collaborated across the PharmSci network to standardize practices, assist in the implementation of the GDMS, and achieve efficiency in key system focus areas (e.g. documentation, processes, and records administration), and guarantee quality systems are a competitive advantage for PharmSci.

• Received the Excellence award twice. Once for Submission of Issue Tracking Database in Support of eQMS Deployment and once for Acknowledgement of EAEU Inspection Support.

• Awarded the Joy Award for Quality Operations and Environmental Health and Safety at a global gathering.

• Received an equity award for involvement in the BTxPS Cultural Bridging club. Charm Sciences, Lawrence MA October 2019 – February 2022 Production Analyst

Used PPE to work with dry blend chemical batch compositions that comprise antibiotics in dry powder and concentrated liquid forms.

• Using a single station tablet press and a BB2 press, convert batch formulas into tablet format.

• Manufactured liquid batch solution (Buffer) and bulk dispense for downstream processing or directly into sellable customer size bottles in a class 100 clean room.

• Hands on experience in Fast Liquid Protein Chromatography method for extracting big compounds such as apyrase from potatoes.

• Special Projects: COVID-19 Viral Transport Media (swab test).

• Revise and update Production SOPs, as well as preserve Lab records in accordance with policies and procedures. Cross-train in different aspects of the scientific process.

• Train new staff on the production of batch formulations and buffers, as well as the performance of tests on these buffers and formulations.

Front Office / Administration / HR August 2019 – September 2019 Professionally manage all inbound calls and ensure that phone calls are redirected appropriately.

• Provide assistance to executives and other departments.

• Review and forward faxes and emails from the Front Office.

• Ensure that all outgoing mail has adequate postage and is delivered on the same day.

• Assists with ordering, receiving, and stocking office supplies; maintains kitchen and kitchen supplies.

• Maintains office equipment such as fax machines, copiers, printers, laminators, binding machines, and mail sorters, as well as scheduling maintenance services.

• Input payment checks from vendors accurately into the spreadsheet and email scan copies of those checks to finance departments.

Community Group

Classroom Assistant Teacher/ After School Educator October 2018 – June 2019 Create and implement weekly curriculum and program activities in partnership with the Director to provide an inclusive program for all children. Maintain and update records on the health, safety, and emergency circumstances of children.

• Collaborate with enrichment teachers to develop and execute strategies for closing the achievement gap in elementary school for second language learners.

• Improved student learning in the classroom and to use operational expenditure budget effectively and efficiently in comparison to goal.

Walgreens

Pharmacy Technician/ Cashier/ Customer Services August 2008 – August 2016 Input prescriptions, distribute medication, and interact with customers.

• Communicated with healthcare professionals at various levels, including doctors, nurses, and insurance company representatives.

• Maintained and managed pharmacy areas, kept inventory, trained, and supervised other pharmacy staff. Helped the pharmacist with day-to-day operations.

• Assisting consumers in locating and selecting the appropriate product. EDUCATION

Bachelor of Science (BS), Health Science

Minor: Jewish/ Muslim/Christian Relationship

Merrimack College

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