The summary provides information on Kristine Kowalski's background and experience in quality assurance, validation, and regulatory affairs. She has over 13 years of experience in these fields, including serving as the Validation Manager at Cody Laboratories for over 4 years. She has extensive experience leading validation projects, writing documentation, ensuring compliance, and mentoring others. Her skills include validation, cleaning validation, computer system validation, and regulatory submissions.

1. KRISTINE KOWALSKI
2 Breezy Lane, Cody, WY 82414 | 307-202-1596 | krististaebler@hotmail.com
Summary
A highly motivated, results-driven, adaptable manager with significant experience in technical and validation
services, quality assurance, project and department management. Highly proficient in creating policies,
procedures, and master plans, in compliance and regulation, troubleshooting, deviations and investigations,
process improvement and change management, schedule management, project coordination, strategic planning,
report generation, production operations, training and mentoring, equipment commissioning and qualification,
process and cleaning validation, document management, and data analysis. A resourceful leader who empowers
an organization to improve patients’ lives by achieving key business objectives and maximizing efficiencies.
Core competencies and skills include:
▪ Quality Systems: 21 CFR Parts 11, 210, and 211; ICH Q3, Q7, Q8, Q9, Q10, Q11, and Q12; Guidance for
Industry – Process Validation: General Principles and Practices. FDA audits, change management,
manufacturing batch records, SOPs, detailed investigations and deviations (development, manufacturing,
and OOS), root cause analysis (Ishikawa, 5 m’s, 5 whys), CAPAs, CAPA effectiveness, pFMEAs, and various
forms of risk assessments. Exposure to EudraLex Vol. 4.
▪ Equipment Commissioning and Qualification:
o API: jacketed reactors, filter dryers, centrifuge / dryer systems, mills, sieves, pumps (metering,
peristaltic, CIP, centrifugal, diaphragm), continuous extraction units.
o FDF: batching vessels, filling lines: bottle purgers, peristaltic and piston filling machines, cappers,
re-torque machines, induction sealers, labelers, cartoners, casing, palletizing, and serialization.
o Utility Systems: compressed air, USP purified water (RO and CDI), temperature control modules
with heating / cooling systems (steam boilers / chillers), vacuum pump systems, HVAC (design to
Class 100,000), process vent systems.
▪ Process Validation: Directly participated in the transfer of over 10 manufacturing processes from
development to commercial manufacture. API and API Intermediates (catalytic, enzymatic, and
electrolysis reactions; extractions (phase cuts and continuous), distillations, crystallizations /
precipitations, and product washing purifications; and drying). Finished Dosage Form liquid products
(formulation, filling, labeling, and packaging). Process design documentation, CPP identification, and
statistical analysis (trending and process capability).
▪ Cleaning Validation: Authored, executed and finalized numerous cleaning verifications and validations.
Determination of maximum carryover limits, sampling locations, worst-case residues and cleaning
conditions, and clean hold studies. Specific analytical methods (HPLC) and non-specific methods (TOC,
conductivity).
▪ Computer Systems Validation: Functional specification and functional testing (SAT/IQ/OQ) of PLC
program sequences, HMIs, plant historian, SCADA, computer platforms, and GMP software.
▪ Regulatory Affairs: Author, review, and format Drug Master File sections. Data compilation and
summarization for NDA and ANDA submissions. Guidance for Industry: Changes to an Approved NDA or
ANDA and CMC Postapproval Manufacturing Changes To Be Documented in Annual Reports.
Experience
Cody Laboratories, Inc. of Lannett Company, Inc., Cody, WY 5/2006 – 8/12/2019
Validation Manager (7/2015 – 8/12/2019)
▪ Supervised validation department team of up to 5 team engineers and 4 consultants.
▪ Prioritized, coordinated, and managed multiple/concurrent key projects and deliverables; ensuring timely
completion that supported project and production deadlines.

2. 2
▪ Communication of project status, deliverables, and changes to validation department and upper
management.
▪ Authored validation master plans, validation project plans, SOPs for process validation, CPV, statistical
analysis, cleaning validation (policy, MACO limit determination, sampling), equipment and utility qualification
(including risk-based approaches), re-qualification, like for like and functionally equivalent equipment
changes, elemental impurity control strategy, risk assessments, and validation life-cycle management.
▪ Key team member in establishing Quality System procedures for master change control, deviations, and
CAPAs / CAPA effectiveness.
▪ Implemented and validated numerous API manufacturing processes into commercial production. Timely
authorship of DMF sections for prompt DMF filing post process validation.
▪ Thorough review of manufacturing and cleaning processes for sound science, robust process understanding,
and implementation of proper control strategies.
▪ Assisted in development of thorough product development stage-gate model. Comprehensive knowledge of
required deliverables from all departments, with ability to step in as project manager.
▪ C & Q of new pilot plant (build out of 4 new API suites), major equipment up-grades to existing API suites,
and timely qualification of serialization line.
▪ Participated in design of a new manufacturing site. Reviewed and established specifications for equipment
and utility design.
▪ Implemented cleaning validation for API equipment for numerous product change-overs. Established excel
sheets with fixed calculations to allow for instant MACO calculations upon data entry.
▪ Validation SME and point of contact in successful FDA audits, with no observations related to validation
practices under my management.
▪ Generated / reviewed C & Q documentation including URS, FRS / FS, FAT/SAT, CQ, IOQ, and PQ.
▪ Generated / reviewed process design and validation documentation including A3/engineering reports,
spiking study reports, process design reports, pFMEAs, process risk assessments, process validation, and
cleaning verification/validation.
▪ Reviewed documentation in support of commercial production (deviations, master change controls, work
orders, OOS reports).
▪ Reviewed analytical method validations for cleaning validation (low residue HPLC). Review of analytical test
results (product and cleaning). Reviewed analytical methods in association with OOS reports.
▪ Conducted internal audits of validation department and quality systems.
▪ Management style adapted to individual employee. Provided resources and knowledge transfer for
employees to grow in their regulatory and technical knowledge and skill set.
▪ Mentored my department and other staff in both regulatory and technical fields (validation, cleaning,
qualification, GMP, process design, and equipment operation). Mentored employees new to the industry.
Counseled staff in communication skills.
▪ Cultivated cross-functional teams to ensure thorough and complete project execution and associated
documentation packages.
▪ Adapted to changes quickly and provided prompt regulatory and validation insight to maintain fast paced
manufacturing schedule, swift implementation of process improvements, or to immediately address
process issues.
▪ Fostered a united validation department, who supported each other with a genuine commitment to the
patient and to the success of the company.
Validation Specialist (8/2007) → Validation Specialist II (8/2010) → Senior Validation Engineer (8/2013 – 7/2015)
▪ Authored numerous equipment and utility commissioning and qualification documents (IQ, OQ, PQ),
process validations, cleaning verifications and validations.
▪ Managed projects to ensure individual tasks and major milestones were completed on schedule, meeting
deadlines even with up-front project delays.
▪ Trained co-workers in key validation and general GMP concepts and regulatory requirements.
▪ Supported DMF, NDA, and ANDA filings.
▪ Validation contact for FDA audits. Successfully fielded FDA inspectors’ questions.

3. 3
Quality Assurance Specialist (5/2006 – 8/2007)
▪ Inspected manufacturing suites, filling line operations, and production documentation.
▪ SOP coordinator. Reviewed / generated SOPs, managed SOP change control, and maintained SOP
distribution. This included review of procedures for implementation of new liquid FDF batching, filling,
labeling and packaging equipment lines.
▪ Reviewed / generated manufacturing batch records and deviations.
▪ Created and maintained efficient and accessible document filing and distribution systems.
▪ Review of quality system SOPs (deviations, SOP generation, batch record issuance, GMP training).
QA/QC Intern (5/2005 – 8/2005)
▪ Assisted with GMP document creation, formatting, and review.
▪ QC Lab Tech / Assistant – assisted in analytical testing (chromatography, phase separations / titrations,
pH), reported results, and maintained lab / labware cleanliness.
SKILLS / PROFICIENCIES
Excellent technical writing and communication abilities. Highly proficient in Microsoft Office [Word (formatting,
headings, styles, design, developer etc.), Excel, Excel Macros, Project, PowerPoint, and OneNote], Adobe Acrobat,
and SharePoint / intranet sites.
Experience with SAP, Visio, Minitab, and SMS-360 safety risk management software.
▪ Bachelor of Science in Biology, University of Wyoming, Laramie, WY, 5/2006
o Cumulative GPA: 3.61, Dean’s / President’s List
PROFESSIONAL DEVELOPMENT
▪ ISPE, Turning QbD into a Practical Reality, 2013
▪ Institute of Validation Technology’s 19th
Annual Validation Week, 18 contact hours, 2013
▪ CfPIE, Process Validation and Best Practices for an Effective Cleaning Validation Program, 2009
▪ Former member of Institute of Validation Technology (IVT) and International Society for Pharmaceutical
Engineering (ISPE)
▪ Soft skills training in leadership (2013 - 2014), 5S, tier boards / communication, Crucial Conversations, and
‘green-card’ improvement systems. Trained on Lean / Six Sigma practices and principles
INTERESTS / HOBBIES
▪ Nature Photography: https://www.facebook.com/Wildly-Inspired-Nature-Images-348458375251446/
▪ Backpacking
o Bighorn: Lake Elsa, Rainbow, Crater / Upper Crater Lakes, Pouch Basin, Lake Geneva, Crystal Lake, Horseshoe Lake, Lost
Twin Lakes, Shell Lake, Rinehart Lakes. Shoshone / Bridger: Titcomb Basin, Mistake Lake, Island and Jean Lakes, Green
River Lakes to Slide Rock and Valaite Lakes. Custer Gallatin: Becker Lake, Albino Lake, Martin and Crystal Lakes, Native
and Lonesome Lakes, Rock Creek to Rock Creek (Black Canyon, September Morn, Mary Lake), Russel, Marianne and Lake
of the Winds, Goose and Incisor Lakes, Timberline Lake, Pine Creek, Mystic Lake, Stillwater.
▪ Day Hiking
o Shoshone: Fire Memorial, Elk Fork, Sweetwater Creek, Kitty Creek. Bighorn: Emerald Lake, Porcupine Falls, Bucking Mule
Falls, Medicine Wheel. Targhee: Table Mountain. Custer Gallatin: Glacier Lake, Sheep Herder lakes, Heart Lake, Granite
Lake, Hauser Lake area, Lake Reno, Lilly Lake, East Rosebud. National Parks / Recreation Areas: Yellowstone (Avalanche
Peak, Bunsen Peak and Osprey Falls, Mt. Washburn, boardwalks, Geyser and Biscuit basins), Grand Teton (Jenny Lake,
Taggart Lake), Zion (Narrows, Upper Emerald Pool, Canyon Overlook), Bryce, Big Horn Canyon (State Line, Hillsboro ghost
town, Lockhart Ranch).
EDUCATION

4. REFERENCES
Steven Hartman
Site Quality Head, Cody Laboratories
406-360-5841
Shartman44@yahoo.com
Michelle Renfors
Vice President, Cody Laboratories
435-901-2100
michelle.renfors@gmail.com
Howard (Bud) Melcher
Regulatory Affairs Manager, Cody Laboratories
307-250-4281
melcherbud@gmail.com
Direct Report References:
Charles Alexander
Validation Engineer II
caalex87@gmail.com
307-213-0401
Kelly Martin
Sr. Validation Engineer
kam4345@gmail.com
307-250-5740
Shaunak Kulhalli
Validation Engineer I
shaunak.kulhalli@gmail.com
848-219-0006
Additional references available upon request.