Quality Assurance Specialist Ii

RANI SANNAN, PharmD, MSc

Gaithersburg, MD ***** • 734-****-*** • **.****.******@*****.*** • linkedin.com/in/rani-sannan-pharmd-msc-31869b144/ QUALITY SPECIALIST II

PROFESSIONAL SUMMARY

§ Dependable, self-motivated, and friendly professional leveraging extensive quality assurance experience in office as well as pharmaceutical production facility environments to support manufacturing stages towards overall efficiency.

§ Proven track record of executing deviation investigations independently or with operational team members to identify practical strategies for continuous production improvement.

§ Utilize solid verbal and written communication skills during complex deviation investigations with multiple groups as well as collaborate with cross-functional teams to implement critical operational policies for maximum compliance.

§ Results-oriented team member, proficient in utilizing various advanced investigation methodologies such as root cause analysis and technical impact assessments during investigations to apply measures for production optimization. CORE EXPERTISE

Deviation Investigation Management Documentation & Reporting Database Administration Continuous Manufacturing Process Improvement Verbal & Written Communications Supply Chain & Logistics Management Quality Assurance Maximum Regulatory Compliance Root Cause Analysis Technical Impact Methodologies Problem Solving Training & Coaching Workload Management PROFESSIONAL EXPERIENCES

AstraZeneca

QUALITY SPECIALIST II August 2022 – Present

® Oversee the Quality Assurance activities that directly support the execution of the process for commercial and clinical products manufactured at the facility.

® Assist in evaluating and disposing of batch release, change control and documentation, equipment and process validation, deviation investigations, supplier management, distribution center management, and regulatory interactions.

® Generate real-time documentation review in production areas while adhering to the standard operating procedures and complying with cGMP.

® Identify disposition of Solutions Preparation and Master Production records, approve maintenance work orders, and develop master data for production use.

® Utilize various electronic system tools such as Trackwise, GQCLIMS, Pas-X, and SAP.

® Facilitate process improvements and risk assessments; benchmark internal and external QA practices to identify innovative, efficient, and effective practices.

® Work with Quality Control to approve EMIRs, UIRS, LIMS modifications, and BOT and EOP reports.

® Aid in the revamping processes as a workflow coordinator, revise controlled documents for approval and produce SPRs and MPRs utilizing Aegis System for manufacturing use.

® Provide Quality Systems assistance by coordinating, reviewing, and approving non-conformances and VSCRs in the Trackwise.

® Stay abreast of evolving regulatory compliance practices and recommend implementation strategies to the supervisor.

® Conduct task-oriented training to specialists and represent QA on-site committees such as SHE. QuVa Pharma, Inc. Bloomsbury, NJ

INVESTIGATOR & CONTINUOUS IMPROVEMENT SPECIALIST October 2021 – July 2022

® Conducted deviation investigations and wrote incident reports in coordination with cross-functional Quality groups to identify root causes and implement practical corrective/preventative actions for continuous improvement.

® Established clear verbal and written communications across multiple groups to mobilize deviation closures as well as meet production/product release requirements for service excellence.

® Employed advanced root cause analysis methodologies with technical impact techniques during investigations to formulate strategies for increased efficiency, reduced cycle time, and optimized manufacturing processes to eliminate non-value work.

® Showcased ability to manage multiple priorities using reliable time management techniques to submit critical requirements within deadlines and escalate complex issues for prompt resolution.

® Participated in mentoring new team members with standard operating procedures and assist cross-functional groups with metric reporting as well as workload distribution to keep a stable workforce regularly. QUALITY ASSURANCE TECHNICIAN August 2021 – October 2021

® Performed essential Quality Assurance (QA) functions in verifying incoming materials, documents, and support areas to ascertain manufacturing compliance with patient safety, efficiency, as well as timeliness.

® Leveraged subject-matter expertise in applicable federal, state, and local regulations with current Good Manufacturing Practices (cGMP) to ensure optimal industrial procedures/practices for workflow excellence. RANI SANNAN, PharmD, MSc

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® Verified critical information relating to incoming materials receipt and goods distribution, such as labels against batch records requirements, to maintain QA standards for customer satisfaction.

® Partnered with the Quality Management team in fostering cleanliness of components and equipment before, during, as well as after manufacturing processes to maintain established company standards constantly. Nova Southeastern University, College of Pharmacy Fort Lauderdale, FL ADMINISTRATIVE OFFICE ASSISTANT August 2019 – July 2021

® Provided direct administrative support to the College Dean, such as recording minutes during meetings for documentation purposes.

® Utilized photography and Adobe Photoshop skills in creating marketing materials for various events to promote pharmacy appreciation among students, such as the Women Pharmacist’s Day and Breast Cancer Awareness, while in compliance with school regulations.

® Facilitated the Pharmacy Graduate Admissions and Student Services’ social media management by implementing marketing strategies to generate followers and amplify college visibility.

® Delivered clerical support using MS Excel to generate alumni relations reports and manage graduates' databases for record keeping.

® Exhibited leadership in preparing logistics for the REACH Day, a research presentation event for faculty members and students. OTHER CAREER EXPERIENCES

Al-Nahdi Medical Company, Mecca, SB April 2017 – May 2017 INTERN

Worked as a Community Pharmacist and Healthcare Administrator during a one-month rotation to enhance technical knowledge regarding drug manufacturing, supply chain, and drug testing compliance. Doctor Soliman Fakkeh Hospital, Jeddah, SB January 2017 – March 2017 INTERN

Acted as a clinical pharmacist for the Infectious Diseases and Internal Medicine department within a two-month rotation. King Abdul-Aziz Hospital, Mecca, SB November 2016 – December 2016 INTERN

Served as a clinical pharmacist for the Internal Medicine and ICU department within a two-month rotation as well as inpatient/outpatient within a three-month cycle.

EDUCATIONAL BACKGROUND

Master of Science in Pharmaceutical Sciences and Social Administration Pharmacy Nova Southeastern University August 2019 – April 2021 Bachelor of Science in Doctor of Pharmacy (Pharm. D) Ibn Sina National College 2010 – 2016 TRAINING, CERTIFICATIONS, LICENSES, & AWARDS

Certificate in Clinical Pharmacy Ibn Sina National College Certificate of Basic Life Support

Saudi Professional I Certification

Researcher, Collaborative Institutional Training Initiative Program Recipient Scholarship for the Saudi Cultural Mission Participant, Cold Chain Distribution Workshop Doctor Soliman Fakkeh Hospital, March 2016 Participant, 1st Pharmaceutical Science Security Forces Hospital in Mecca, April 2016 Participant, 1st Intravenous & Parenteral Nutrition Symposium Cleveland Clinic, November 2015 CIVIC ENGAGEMENT

Volunteer, Nova Southeastern University Vaccination Site March 2021 – May 2021

Leader, Saudi Student Association

Nova Southeastern University, College of Pharmacy

Volunteer, Awareness of Herbal Remedy

Saudi Food & Drug Authority

Volunteer, Safe Medication Practice: Implication of Informatics & Automation Symposium King Abdullah Medical City

Technical Skills: Trackwise, GQCLIMS, Pas-X, SAP, MS Office (Word, Excel, PowerPoint, Outlook) Google Apps (Gmail, Drive, Docs, Sheets, Slides, Forms) OpenOffice Calc

Languages: English (Native) Arabic (Native)

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