Aleksandr Katz 443-***-****

**** ****** ** *** *, Baltimore, MD 21209 ac2f2n@r.postjobfree.com

Quality Assurance Associate

Quality Assurance Associate with 5+ years of process quality experience. Ability to interpret and understand the current processes to be able to create and improve new quality systems to benefit the entire organization.

Career relevant skills

Experienced in issuing line clearances for all unit operations of batch manufacturing.

Perform in process checks for capsules, tablets, softgels and packaging operations.

Experienced in performing audits throughout facilities.

Revise, review and approve quality related documents.

Perform AQL tests and samples for in process and finished drug products.

Perform in process blend uniformity and composite samples.

Review finished and in process batch production records.

Professional Experience

Pharmaceutics International Inc., Hunt Valley, MD

2012-2017

Process Quality Inspector

Responsibilities:

Managed & provided Quality Assurance support to fast pace multiple cGMP projects.

Provided Quality Assurance guidance to Quality Assurance personnel.

Provided Quality Assurance updates to the clients.

Coordinated and approved product release to the clients.

Provided guidance and quality assurance support to cGMP manufacturing personnel for compliance.

Managed, coordinated, reviewed and assisted approval of Quality related documents for cGMP activities.

Ensured procedures and policies are in compliance with applicable FDA and International guidelines.

Ensured raw materials, intermediate products and final products are appropriately released as per requirements.

Ensured equipment qualification, maintenance and calibration programs are effective.

Reviewed and approved GMP analytical data for compliance.

Ensured analytical methods are qualified and/or validated appropriately in accordance with FDA and ICH guidelines.

Performed and supported audits for GMP activities to evaluate the compliance with the procedures and practices.

Managed quality documents such as batch records, test methods, product labels and other documents for cGMP activities

Reviewed completed batch records, Environmental monitoring data, laboratory records and other ancillary data for product release.

Reviewed and provided feedback comments on investigation reports, protocols/reports/specifications and other quality documents.

Provided ongoing assessment, ideas and assistance in enhancing quality systems.

Responsible for continuous improvements to the PII Facility and Quality Systems.

Provided guidance and training to staff regarding GMP compliance.

Reported quality deficiencies to the Department Heads.

Other duties as assigned.

Personal Qualities

Positive attitude.

Highly ambitious.

Quick learner.

Independent worker.

Work well with others.

Fast pace problem solving skills.

Excellent communication skills.

Fluent in Russian language.

Strong eye for detail.

References

References are available upon request.

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