Page *

Azadeh Namvar

***** ******** *** **, **********,VA,20148

Phone: 202-***-**** Email: ac6a0q@r.postjobfree.com Targeting opportunities in Biopharmaceutical testing Knowledgeable in Microbiology and compliance with over a decade of experience in Compliance Department and supporting the Documentation and Security Manager with monitoring state and federal laws and regulations and supporting conformity and adherence. Managing the processes of regulatory compliance, operational processes as they relate to various Pharmaceutical companies and government sector entities and supervising the flow of data through various Pharmaceutical companies’ systems. Bring a comprehensive skill set in experiment design, protocols, and laboratory techniques, complemented by the analytical strengths needed to interpret study results. Well-versed in Good Manufacturing Practices (GMPs), Good Laboratory Practices (GLPs), FDA, and OSHA. Acting as backup support for government agencies including CBP, EPA regulated products, USDA, FDA and skilled at applying these principles within a practical setting. A personable relationship builder with a talent for fostering positive working relationships with staff, regulators, clients, and key stakeholders. Inform the Project Managers and Account Manager of the project progress. Responsible for method modification and development and validation of new methods.

AREAS OF EXPERTISE

Regulatory

Compliance

Trend analysis

Research & Analysis

(R&D)

GMP’s and GLP’s

Quality control and

quality assurance

Effective

organizational and

communication skill

Make

recommendations for

systems' parameters

to support compliance

requirements

Team Leadership

Statistical analysis

Diagnosing test

failures

GLP, USDA animal

welfare act, ISO/IEC

17025:2005 standard

and IACUC standards

Page 2

Analytical techniques

PROFESSIONAL EXPERIENCE

Bacteriology Laboratory Supervisor

2017-Present

BioReliance, Rockville, MD

Overseeing a wide variety of assays or tests required to characterize material and/or processes, in addition to supervision of associate scientists in the lab. Making scientific observations, maintain detailed workbooks/documentation and ensure all documentation fulfills generally accepted professional/industry standards. Maintaining an understanding of technological principles and applications of the organization’s services.

Possess the technical knowledge and analytical ability to perform and analyze data for commercial studies and R & D projects performed in the lab.

Keep the Study Director(s) / Scientist(s), Account Manager (s), and Project Manager (s), informed of study status, technical problems and other issues which could impact studies.

Coordinate (schedule) all activities associated with the lab.

Lead weekly lab meetings and discuss experimental design for incoming studies with the lab technicians.

Track studies progression and ensure that all timelines are met up to draft reporting stage.

Ensure that the lab has the required scientific equipment, instrumentation, and computer systems; ensure that they are in a validated state.

Ensure that training levels are maintained for all technicians, and that training needs are identified and addressed as appropriate.

Demonstrate consistently good communication and interpersonal skills with employees, management and sponsors.

Page 3

Ensure that training files for all employees and outside slide scorers are up to date with necessary training.

Equipment purchase and qualification

Laboratory design and build out

Development of relevant standard operating procedures (SOPs)

Method validation/qualification

Develop and monitor project plans and schedules for QC onboarding of new testing

Technical evaluation of component and process changes for impact to QC functions and activities

Coordination of qualification/validation testing. Managing timelines for samples, testing and other deliverables.

Participate in cross-functional teams to resolve product quality issues, corrective actions, investigations and develop/implement in process improvements

Draft relevant technical sections of regulatory documents

Provide support for investigations and other quality process documents

Lead cross functional teams and manages the deliverables for the assigned projects. Drives projects through completion within timeline, quality and budgetary constraints.

Provide guidance to QC Management in assessing resource, equipment and space needs.

Proactively identify issues and provide general guidance to resolve QC operational issues and works with leadership to develop solutions to meet objectives.

Regularly interact with Sr. Management or executive levels. Exercise judgment and exert some influence on the overall objectives and long-range goals of the QC Department. Represent the department in relevant internal/external committees.

Serve as a primary point of contact among functional areas for QC aseptic fill support.

Lead special projects as assigned by supervisor/department management. Page 4

Drive the necessary cost control and process improvement actions to ensure the budget is met.

Lead by example, offer coaching and mentoring to all other staff.

Promote a culture of continuous improvement within the department. Act as champion on initiatives and/or projects to drive improvement in quality and/or client service.

Track all business metrics as they apply to the specific department, and take action when adverse trends or other issues arise.

Complete performance reviews fairly and on-time; conduct regular one-on-one discussions with employees; interview and hire job candidates; ensure development plans are in place for all key staff members.

Adheres to applicable safety SOPs and follows applicable safe work practices.

Adheres to ISO/IEC 17025:2005 standard for laboratory testing as specified in applicable standard operating procedures or quality manual.

Act as a deputy to technical manager for ISO/IEC 17025:2005 Project manager, Team leader

2010-2016

University of Guelph – Guelph, ON

Developed a webinar for Administrative and Maintenance policies and procedures.

Trained all applicable associates on policies and procedures currently in place.

Provided suggestions on the procedures and systems being reviewed, reported on the recommendations and findings.

Implement cGMP system(s) and ensure compliance with all procedures and policies.

Write and revise applicable policies and procedures for departments as aligned with corporate policies and expectations

Oversees the daily operations of the microbiology department.

Oversees QC equipment validation, maintenance and calibration and QC laboratory scheduling and maintenance.

Manages the EM program and corresponding personnel. Page 5

Manages the microbiology laboratory activities and personnel. Main team tasks include environmental testing, personnel testing, aseptic process simulation testing, endotoxin testing, and incubation.

Manage the review and approval of specifications and test methods.

Reviews and approves product testing for finished drug product and raw ingredients

Evaluates and approves out-of-specification (OOS) investigations; trends the OOS’s. Provided tracking and trending data to Quality Assurance on a monthly basis.

Ensure the completion of all non-conformance, deviations and other quality related issues associated with laboratory investigations.

Ensure the laboratories are properly equipped to maintain a high performance level for reliable test results applicable with all GMP’s and GLP’s.

Ensure laboratory personnel meeting required training and/or certification(s).

Cross-trained with other team members and will begin training associates in those areas.

Participated in all due diligence activities.

Leveraged finely-tuned written communication skills to develop applications for grants, draft project reports, and review the articles written by students.

Led teams of Research Assistants through study execution to ensure that the studies are completed in accordance with protocols.

Assists in coordinating workload, staffing, reporting, technical oversight, and client services within the clinical laboratory

Determines proper procedure/methodology collecting and analyzing laboratory specimens and recommends modifications as needed to insure accuracy and quality of test results; provides in-service to appropriate laboratory, staff related to these modifications

Contacts reference laboratories for such issues as special sample handling, test results and transportation of specimens

Confers with reference laboratory with issues such as test or methodology validation, new testing procedure requests from technical staff

Inspects laboratory equipment and instrumentation by monitoring calibrations, linearity and control testing to insure proper function, evaluate need of repair or replacement

Reviews and revises procedural manual annually and as needed Page 6

EDUCATION

PhD Microbiology, 2010 University of Guelph, Guelph, Ontario, Canada MSc in Microbiology, 2005 University of Guelph, Guelph, Ontario, Canada BSc in Agriculture Engineering major in Food Science, 1995 University of Azad, Tehran, Iran COMMUNITY INVOLVEMENT

MEMBER, 2006-PRESENT: ASM, NCFPD

REVIEWER, 2010-2018: Canadian Journal of Microbiology, Food Research International, International Journal of Food Microbiology, Journal of Food Protection

Contact this candidate