Currently I am pursuing my certificate in medical writing and editing. I am looking into careers in regulatory affairs, medical writing, and laboratory affairs.
Specialties: I have experience with general lab science in biology and chemistry. This includes extra chemistry courses I undertook to allow me to get a grasp on techniques like gas chromatography and extraction of plant products, like essential oils. I am also willing to learn new skills, and GIS location tracking. Similarly, I have knowledge of how clinical trials are run and scientific writing from my work towards being certified as a medical writer.
Medical Writer I @ Primary Function Job Function: Drafts and edits domestic and international regulatory submissions for diagnostic assays and annotates labels graphics.
Core Job Responsibilities: Serves as the Medical Writing representative on the Global Harmonized Symbology (GHS) team. Obtains relevant GHS data and information, and uses Adobe Acrobat annotation tools to annotate (redline) and proofread graphics in label files. Writes, edits, and proofreads PMA supplements and/or technical files supporting the label changes. Uses submission templates and format/style guidelines established by Medical Writing to prepare the submission documents. Arranges and conducts submission review meetings as needed, and circulates final product submission documents for approval. Assembles, inspects, and duplicates approved submission documents. From June 2014 to Present (1 year 7 months) Market Complaint Investigation Associate @ Receive, login, document, investigate and closeout complaints as required by the applicable SOPs.
Communicate and coordinate all complaint related activities with other departments such as Regulatory Affairs (RA), Quality Assurance (QA), Quality Control (QC) laboratory, Stability, Document Control, Warehouse, Medical Consultant and complainants (primary/secondary) in order to close the complaint in a timely manner as required by the applicable SOPs.
Review complaint investigation reports and corresponding documents, including response letters, for accuracy and completeness.
Organize the complaint folder and forward the verified, reviewed, and completed complaint investigation folder to the Supervisor of Compliance for further comments.
File MedWatch Reports as needed.
Maintain the complaint database, so it is current and accurately captures all complaints. Maintain and organize the complaint files in a designated area.
Correspond with departments as needed on corrective actions after closing the complaints and follow-up.
Provide weekly complaint status report to the Supervisor of Compliance.
Trend complaints monthly and issue metrics to the Supervisor of Compliance.
Maintain complaint handling procedure and enhance as necessary.
For any other departments, get an approval from the Supervisor of Compliance.
Coordinate and assist in the reporting of articles identified as part of the literature search requirement.
Serve as a back-up to and assist with APRs. From October 2013 to June 2014 (9 months) Quality Assurance Lab Tech (Microbiology) @ -Performing microbiological testing on raw materials, in-processed, and finished goods
-Collecting line samples and conducting microbiological monitoring throughout the plant
-Entering and documenting results under cGDP standards
-Performing environmental monitoring and improving the standards of the plant
-Managing inventory and ordering of new equipment or supplies
-Organizing the workflow and improving the efficiency of lab (time management)
- Performing validations and verifications of instrumentation and equipment
-Preform microbiological testing to ensure product safety and a sanitary environment within the plant, folowing cGMP, cGLP, HACCP, ISO, and FDA. Provide appropriate paper work to prove adherence to guidelines. From March 2013 to August 2013 (6 months) Volunteer Research Assistant @ Preform RFLP, PCR, DNA extraction, Gel Electrophoresis, and Data Entry From April 2012 to March 2013 (1 year) Sales Associate and Jewelry Technician @ -Provide customer service
-Assist with repairs
-Track expenses From August 2011 to March 2013 (1 year 8 months)
Bachelor of Science (B.S.), Biology, General @ University of Illinois at Chicago From 2007 to 2012 PAWEL WOJTACH is skilled in: Bilingual Polish and English, Writing and Office Communication, Gel Electrophoresis, DNA extraction, PCR, HPLC, Microbiology, Chemistry, Science, Genetics, Research, Lifesciences, Biochemistry, Biology, Microscopy