Danuta Bisek

*** ******** *** ac0gcm@r.postjobfree.com

Avenel, NJ 07001 732-***-****

Professional Summary: Results oriented professional Quality Control scientist with extensive background in laboratory analytical testing, data recording and review. Excellent organizational and problem solving skills as well as the ability to operate in a fast paced, dynamic environment have contributed in achieving company business objectives.

Key Skills

Chemical Analysis, Product Stability Testing, Sampling, Finished Product and Component Inspections, Quality Audits, Wet Chemistry Techniques, Graphs, Specifications, COA/COR development, GMP Compliance, Cross Functional Communications and Team Building

Professional Experience

Novel Ingredients – East Hanover, NJ

In Process Quality Control Specialist (2015- Present)

•Work with various nutraceutical powders to determine bulk density, tapped and untapped and particle size. Weigh material, place samples on RO-TAB machines, calculate weight for each mesh size. Responsible for recording and input of all results in Data Management System as well as communicating results to appropriate parties.

•Perform final, sterile composite samples from finished manufacturing products, submit samples for Micros, Assay, Heavy Metals, Retention, LOD, Testing,

•Conduct special tests on Micro Air Jet Sieve instrument based on customer requirements for special materials.

•Review manufacturing batch records.

•Perform visual/physical review of products as needed.

•Perform thorough and complete routine testing on materials according to specifications and submit reports in a timely manner to meet QC/QA requirements, manufacturing and shipping schedules.

Merck Pharmaceutical

Scientist of Packaging Components & Raw Materials (2006-2015)

•Conducted primary packaging components testing to support clinical studies requirements.

•Conducted visual and analytical tests of raw materials, in-process and finished goods ensuring produced items are within approved specifications.

•Responsible for receiving, storing and testing all incoming samples.

•Performed production line inspections and documented results (visual, weight, torque, vacuum testing).

•Conducted on-time product stability testing utilizing RLIMS system with respect to packaging component and raw material samples.

•Worked with OSPD group in the development of package components specifications; provided SME technical expertise.

•Prepared timely COAs and COR for all tested samples and forwarded completed batch records to PSQ-MD for final approval.

•Initiated and completed NOE/ CAPA and tracked progress of affected lot release.

•Conducted technology transfer for LMC project at LPO; as an SME, provided successful qualification training for LPO employees.

•Performed wet chemistry identification tests: ID Titanium Dioxide; ID Ferric Oxide; Film Formation; ID for Gelatin; Loss on Drying and Coating by drawdown card film.

•Conducted package observation of filled tablet and capsule packages and package observation of filled liquid and semi-solid product packages.

•Coordinated and reviewed all documents for water samples received from other labs for Mill – Q units.

•Met all quality measures for internal and external audits and inspections.

•Participated in MPA audits and inspections, prepared safety activities for the group and conducted monthly self-inspections.

•Calibrated and maintained laboratory instruments

•Cross trained and reviewed inter-departmental peers.

Schering – Plough Research Institute - Kenilworth, NJ

Packaging/Component Development Specialist (1999-2006)

•Conducted testing according to protocols and standard operating procedures.

•Supported special test requests.

•Performed IR analyses, specific gravity, ash content, delivery, and metering leak tests.

•Responsible for QC inspection system for package components for R&D stability studies.

•Provided science-based evaluation and solutions to packaging issues.

•Involved with SOP, GTP and other GMP training and compliance issues.

•Monitored calibration and maintenance of assigned laboratory instrumentation.

•Participated in Lachman audit activities.

•Prepared the safety schedule for the laboratory colleagues.

•Conducted monthly safety inspections in the department.

•Cross-trained on all packaging component inspections.

•Provided technical compliance and regulatory guidance.

•Organized and maintained the file sample system.

•Managed inventory in the file sample logbooks.

•Worked for LLS project (the Dream Team) to support the GMP laboratory to achieve the highest level of excellence and service.

•Created file sample spread sheet to facilitate tracking of file sample inventory.

Schering Plough Laboratories - Kenilworth, NJ

Supplier Quality Control SQC Senior Inspector (1997-1999)

•Prepared weekly reports for completed tests and released MI lots.

•Obtained specification and test procedures for components to be tested.

•Issued and monitored labels and packaging inserts.

•Inspected primary/secondary components for visual tests, dimensional, IR, functionality.

•Verified component description, expiration date, Ric #

•Performed SQC testing using MIL-STD-105D.

•Perform physical testing and inspection of packaging components and raw materials. Verified customer art work copy of all components, labels and inserts and document results.

•Verify lot numbers, expiration dates, quantities, customer and DPT part numbers on raw materials and packaging components for accuracy and correctness.

•Performed tests on raw materials.

ADDITIONAL TRAINING/SKILLS

•High proficiency with MS Office Suite.

•Working knowledge of RLIMS, Trackwise, Commandr, Spridox and Saba systems.

•Knowledgeable using the following systems and software: FT-IR; weight loss on drying smartscope, UV/VIS spectrometer. Instron microscope, muffle furnace, halogen moisture analyzer, Fisher precision vacuum oven

•Extensive knowledge on SQC's GTPs, SOPs, GPSs and component drawings.

Education

General Nutritional Academy, Pulawy, Poland

Nutritional Technology Specialist

Pulawy High School

High School Diploma

Fluent in Polish and Enlish languages

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