Technical Writer Training Program

Kayvan Khatibi

***** ******* ** #**, **** Forest, CA 92630

************@*****.*** 619-***-****

Related Work Experience:

June 2023-Crrent: QC laboratory Supervisor: Wakunaga of America.

·Supervise the QC Chemistry staff to include, hiring, training, scheduling, evaluating competency, mentoring disciplining.

·Manage the training program for chemistry analysts in regard to laboratory procedures, analytical instruments and testing methodologies.

·Ensure that adequate and up to date training records are kept for each analyst.

·Oversee a proficiency testing program to monitor the efficacy of the training program

·Review staff performance, address deficiencies and perform annual review assessments.

·Assists in complying with regulatory requirements related to product safety and quality.

·Ensures that procedures are being followed as outlined under FDA, ICH, Standard Methods and the Quality System requirements.

·Reviews records to ensure data meets the industry requirements for data integrity.

·Provides input and quality oversight over investigations, which includes review and approve the investigation reports.

·Provides Quality oversight over equipment/software qualification, calibration and validation.

·Partners with Corporate Quality to implement centralized processes and ensures compliance to industry standards and compendial testing requirements.

·Provide biweekly report of QC raw material and Finished product status to management team for release dates

·Review all lab notebooks for all Chemists and Microbiologist for testing completion and accuracy of data

Feb 2022-Mar 2023: Technical Writer (contract), BBraun Inc.

Principal responsibilites :

·Technical writer with experience handling discrepancies and CAPA investigations experience within the medical device/Pharma industry.

·As part of Technical writer position part of investigation was to ensure the AQL and QC inspection was performed.

·Visual inspection of products for any particulates, debris, bubbles and label was inspected to ensure all information is accurate and legitimate.

·Partner with the team to work on current/new discrepancies(some can be new, some repeat)

·Read investigations, help gather information for new discrepancies and work with the team to do so.

·Working on the investigations and discrepancies (around 75%) and the other 25% will be working/elaborating with the team to gather the data/info needed for them.

·Be able to formulate ideas, have strong logic flow.

·Be able to use their critical thinking skills to understand what evidence is needed for a specific argument.

·Use analytical Lab skills to understand lab results and do logical analysis for final outcome

·3-5 years of experience with FDA is highly preferred.

Apr 2020-Feb 2022: Senior Chemist/QC Inspector (contract), B Braun Inc.

Principal responsibilities:

·Experienced in QC inspection and AQL experience in Medical Device Company for IV bags.

·Perform laboratory analysis of Finished products, stability and raw material samples according to established specifications and procedures.

·Using wet chemistry techniques or various laboratory apparatus and instruments (Micrometer, Caliper, pin gages, HPLC, GC, UV/Visible Spectrophotomer, FTIR, TOC, pH meter, Conductivity meter, etc.) in compliance with B Braun, cGMP, GLPs, SOPs, USP and FDA guidelines.

·Perform routine qualification, calibration and maintenance of laboratory instruments.

·Prepare analytical standards and reagents according to established procedures and specification.

·Conduct investigations for out of trend results and Lab investigations reports and assist Lead Chemist for such reports.

·Scan and compile supporting data for report/document preparation.

·Familiar with ICH and FDA guidelines.

·Excellent technical writing skills and familiar with HPLC/UPLC and proficient in Empower software for Chromatography analysis.

2018-2020: QC laboratory Supervisor: Natural Alternatives Inc.

Principal responsibilities:

·Responsible for planning, organizing, directing and evaluating routine and non-routine activities of the QC Chemistry staff in support of production and R&D and in full compliance with GLP/GMP regulations and NAI policies.

·Oversee the day-to-day chemistry operation to ensure that production and R&D needs are met.

·Plan the daily and weekly work assignments of the chemistry analysts.

·Collaborate with the lab administration team and the manager to assign and revise testing priorities.

·Provides technical guidance to staff in the performance of all approved laboratory procedures.

·Review analysts work and notebook, prepare final reports, ensure that proper record is kept both in printed and electronic forms. Ensure that accurate results are reported in a timely and appropriate manner.

·Evaluate and improve lab procedure in the chemistry lab.

·Perform out-of-specification (OOS) and out of trend (OOT) investigation

·Communicate with other NAI departments about samples and project status.

·Perform data tend analysis for stability studies and communicate observations and conclusions to R&D.

·Manage the qualification, validation and maintenance program for all lab equipment.

·Provide technical leadership for instruments such as HPLC, GC, FTIR and ICP.

·Oversee the chemistry inventor to support effective lab operations.

·Communicate with contractors regarding lab equipment and with vendors regarding specialty consumables.

Supervisory responsibilities:

·Supervise the QC Chemistry staff to include, hiring, training, scheduling, evaluating competency, mentoring disciplining.

·Manage the training program for chemistry analysts in regard to laboratory procedures, analytical instruments and testing methodologies.

·Ensure that adequate and up to date training records are kept for each analyst.

·Oversee a proficiency testing program to monitor the efficacy of the training program

·Review staff performance, address deficiencies and perform annual review assessments.

·Assists in complying with regulatory requirements related to product safety and quality.

·Ensures that procedures are being followed as outlined under FDA, ICH, Standard Methods and the Quality System requirements.

·Reviews records to ensure data meets the industry requirements for data integrity.

·Provides input and quality oversight over investigations, which includes review and approve the investigation reports.

·Provides Quality oversight over equipment/software qualification, calibration and validation.

·Partners with Corporate Quality to implement centralized processes and ensures compliance to industry standards and compendial testing requirements.

Safety responsibilities:

·Maintain a safe, organized and clean work environment in the chemistry lab

·Assist in the management of NAI chemical control program

·Oversee the lab Chemical Hygiene plan

·Manage the lab hazardous material disposal program and oversee the proper disposal of al NAI wastes.

·Maintain an up-to-date inventory of hazardous materials with regulatory agencies

·Act as a QC representative to the safety committee in rotation with the Microbiology Supervisor and lab manage.

Quality responsibilities:

·Maintain GLP and GMP standards and ensure that all NAI procedures and policies are followed within the chemistry lab

·Review and revise Standard Operating Procedures (SOP) and other quality documents

·Participate actively in audits (internal and external) and in remedial actions for any non-compliance observations made in the chemistry lab

2013-2018: Lead Chemist/Lab Supervisor, McGuff Pharmaceuticals Inc.,

Principal responsibilities:

·Manage and prioritize daily operation in the Chemistry lab, Testing of Finished products and raw material on HPLC, TOC, UV/VIS and Titrations based on USP methods

·Order supplies and in charge of testing, reporting, documenting, and preparing reports for all testing in the Chemistry laboratory.

·Routine and non-routine testing of stability, raw material and finished products in a pharmaceutical setting.

·Purchase of Laboratory Instrument to bring in more testing in-house to save on QC budget. Train other technicians.

·Write protocols and final reports as well as conduct testing for Stability and NDA studies with different mixtures and products.

·Performing calibration, validation and other testing reports to QA and management as needed.

·Ordering equipment and setting up parameters for different types of USP testing.

·Schedule and manage testing in a timely manner as needed.

·Writing and editing Standard Operating Procedures for testing as well as for Calibration and Maintenance and protocols, instrumentation and qualification reports.

·Working closely with Quality Assurance to perform calibration of equipment and release of raw material occur as scheduled.

·Assist with QA to determine root cause of Out of Specification in laboratory. Manage the Hazardous waste material and disposing of them with outside vendors in the laboratories and production departments.

·I am certified as a Technical Writer and Hazardous Waste Specialist. Heavy use of HPLC with method development skills.

2008-2013: Senior Quality Control Chemist, NBTY Inc.,

Principal responsibilities:

·Authored and edited standard operating procedures and methods of analysis in the Quality Control laboratory, performed peer review of data and documentation of data from chemists in a GMP/GLP environment.

·Scheduled and conducted meetings concerning standard operating procedures and methods of analysis revisions.

·Coordinated and made priorities for scheduling laboratory instruments for preventative maintenance and repairs.

·Ordered supplies and organized lab with compliance issues for a large QC department.

·Worked with the compliance department and auditors from other companies to resolve GMP, compliance and SOP issues.

·Recorded and created preventative maintenance binders for all instruments, in charge of record keeping of training files for all analysts.

·Assisted Lead technical Chemist with variety of issues and problems in the QC laboratory.

·Testing of different Vitamins, Verify and collect raw data from chemists.

·Help management with audit duties for FDA, NSF or USP.

·Heavy use of HPLC. Experience with LIMS system. Report OOS and conduct follow ups for OOS results.

·Peer review and Audits on chemist’s notebooks and Audits of documents in the lab.

·Experience performing Validation testing and setting up criteria for validation.

·Familiar with making Media for Microbiology testing. Proficient with testing of Vitamin K, Iodide, Citrus Bioflavonoids, Hesperidin and Rutin.

Educational Background:

Technical Writer Certificate, California State University, 2008-2009

Master of Business Administration, University of Phoenix, 2000

Bachelor of Science with a Microbiology Major and Chemistry Minor,

Northern Arizona University, 1990.

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