Objective

Continue to advance, better others as well as myself. To be an essential part of a growing, ambitious company that recognizes and encourages professional growth and understands that even with individual achievement, it is always a collective effort. Experience

Moderna, Norwood, MA — 7/26/2021-present

Senior Associate, Quality Control Sample Management- managing all samples that are made or shipped on site. Samples must be accurately logged into system with appropriate storage conditions, testing assigned and destination lab, before testing can begin. Samples must be maintained throughout life cycle and easy to locate/ retrieve should retesting become necessary. Proper documentation, cGMPs, PPE, gowning techniques a must.

Anheuser-Busch InBev, Inc, Saint Louis, MO — 10/2006-7/16/2021 (65-80 hrs/week average, 6-7 days per week)

QA Block Beer Analyst- owner of all block beer in SLB. Kept track of the millions of cases of beer blocked annually that was not fit for immediate sale. Accurate counting and record keeping, stock adjustments and locations, as every case was tracked and compared to the financial numbers monthly. Ran daily cross-departmental block beer meeting making recommendations on disposition of non-conforming product and weekend rework priorities. Responsible for locating and deciding parameters of non-conforming product in real time and verifying and communicating pertinent info to Logistics and Operations. Experienced with ITFs, annual audits, mock recalls, internal inspections, root cause analysis determinations, inventory discrepancy and OOS investigations, JHA, process improvements, QIs, KPIs, best practices, GFSI, and BRC. Author all rework instructions, review all tracking sheets, direct reprocessing crews, maintain the block until completion in 2 systems simultaneously and complete the monthly block beer risk assessment.

QA UAII- delegating/assigning work to other analysts and techs, managing schedules and priorities to ensure weekly testing/audits are completed in timely fashion either by lab personnel or by line operators, blocking production (determining critical vs. non-critical, making sure all defects and proper time increments are captured), proper notation of material complaints, interacting with fellow co-workers, GM’s, and management to adhere to SOPs and reaction plans, ability to investigate issues and determine assignable root causes. PQA/BQA Lab Analyst- following applicable cGMPs, SOPs and policies, routine FTC sets in orbisphere lab, diastix testing, audits, pH, ballings, sentries, sodium, total alkalinity, yeast cell 314-***-****

adplv0@r.postjobfree.com

196 Walpole St. #2

Norwood, MA

02062

PENELOPE K. MCCOO

count, beer changes and all appropriate notations of results in logbooks, notifying UAII and/or GM’s of issues as necessary. General lab equipment maintenance. Micro Analyst (aseptic testing)- proper filtering of beer on appropriate media, sample collection, labeling and numbering of filtered samples, and notating all logbooks. Plate reading as it pertains to beer and beer spoilers (pediolatics, aerobes, anaerobes), autoclaves, media preparation.

Certified Master Trainer- trained weekenders and other analysts on lab duties in orbisphere lab and in micro lab. Taught initial PQC class for new-hires and annual refresher classes for all employees.

Covidien (formerly Mallinckrodt), Saint Louis, MO — 2004-2007 QCTS (Quality Control Tech Services) Analyst- Validation group set up in response to NRC visit. Assigned to validate and/or rewrite every SOP in use in every department at the facility in certain time frame. Wrote protocols/papers and opinions, reviewed work, ran tests/ experiments to determine best way to proceed, validated protocols in triplicate. Supervised group of technicians, assigning work, keeping track of daily progress, reviewing lab notebooks, ran daily meeting.

QC Analyst- timely testing of radioactive chemicals via GC, AA, LC, to verify isotope and purity prior to releasing bulk for packaging and distribution. American Radiolabeled Chemicals, Saint Louis, MO — 1994-2004 QC Chemist- Quality control and purification of radioactive chemicals for biomedical research via TLC, paper chromatography, electrophoresis, exchange columns, and some HPLC. Kept track of products ordered that needed QC prior to shipping and assigned to chemists as needed. Kept track of progress/deadlines for custom orders and product yield. Trained new lab technicians in radioactive lab. Devised labeling system for location of chemicals numerically by temperature requirement.

Health Physics- Kept track of contamination levels and limits in restricted and unrestricted areas based on NRC guidelines, performing daily wipes of specific and random areas to asses contamination and isotope. If needed, performed investigation to determine probable cause of any contamination. Took air samples weekly to asses amount of radiation in the lab and how much was being released via stacks to environment. Samples liquid waste when tank reached capacity to determine if level of radiation was within monthly/yearly limits to release to sewer system. On-call after hours when accidents occurred in lab to secure area and handle hot waste. Responsible for the testing and training of new employees to handle radioactive/hazardous materials.

Shipping Manager- Proper packaging and labeling of radioactive materials for shipping via ground or air, domestically or internationally under OSHA and IATA guidelines, including necessary documents for shipping and customs purposes. Maintained files for every chemical produced including scans and purity data. Kept inventory of all pre-packaged materials. Wrote first shipping manual for training purposes. Education

Saint Louis University, Saint Louis, MO — BA Chemistry, 1998 Vanderbilt University, Nashville, TN — 1988-1990

Skills

White belt certified, Master Trainer certified, FT certified. Strong analytical skills, detail oriented, cGMPs, excellent written and oral communication skills; equally excellent memory. Proficient in PowerPoint, Excel, Word, SAP. Able to multi-task and manage time efficiently, self-directed. Supervisory/training/mentoring experience, able to work well with others or independently, SME for area, root cause analysis, problem solving, 5Why, 5S, auditing, HACCP, food safety, consumer complaints, checklists, sharepoints, Power BI, BPA. References

Available upon request.