Yyyyyy x. yyyyyy

Xxxxxx, AL xxxxxx ￨ (xxx-xxx-xxxx ￨ abc@xyz.com

Quality Control ￨ GMPs ￨ Multi-Project Management ￨ SOPs ￨GLPs ￨ Regulatory Compliance

Team Building ￨ Training / Development ￨ Workflow Prioritization ￨ Multi-Process Optimization

Six Sigma Green Belt ￨ Multimillion-Dollar Budget Control ￨ Asset Management ￨ Cost-Reducing Initiatives

Laboratory Analysis ￨ Trends Tracking ￨ HPLC ￨ UPLC ￨ ISO9001 Compliance ￨ IR-IR ￨ UV-Vis ￨ Reports Generation

Highly Accomplished Quality Control Chemist who makes sound decisions to reflect positively on pharmaceutical, laboratory, and / or chemical analysis initiatives in alignment with a company s vision, value, and goals. Top Performer who offers solutions-centric critical thinking for change-oriented results, and who continually sees the big picture to execute bold organizational missions. Ambitious Self-Starter who rises above challenges to achieve winning outcomes, including quickly adapting to evolving scenarios to reduce costs, increase efficiency, and identify new opportunities. Excellent Communicator who develops solid relationships with management, peers, and stakeholders, and who leads teams by example and with ethics and integrity.

Career Highlights Include:

  Participating in an Endo Gives Back community outreach program.

  Successfully achieving 6 months with zero analyst-related (NOE) errors.

  Strategically managing a $1.5-million budget and overseeing $1+ million in assets.

  Grading 98.2% on-schedule product portfolios with 0.6% analyst-related (NOE) errors.

  Upholding ISO9001:2000 certification in manufacturing of precision-machined hardware.

  Serving as leading analyst for testing spironolactone portfolio with 256 lots tested since 1 / 2017.

  Achieving recognition by senior Endo management for work associated with HPLC column care and proper system conditioning, SOP rollout, and new hire training; company saved $370,000 for 2017.

Quality Control Chemist II (2016 Present)

Capitalize on the opportunity to lead forward-thinking laboratory analyses, including facilitating product testing, stability testing, cleaning verification testing, and manufacturing in-process testing. Lead a top-performing team of researchers, including 2 chemists and 3 lab technicians to complete projects minimizing glassware contamination and the effects on chromatography. Offer knowledge of buffer / solution and USP standard preparation, and perform lab method transfers and participate in method validation and verification studies.

  Successfully participated in Six Sigma projects with HPLC column care and proper system care.

  Led generalized lab support, including routine instrument cleaning and preventative maintenance.

  Proactively adhered to all manufacturing-centric regulatory, company, and compendial requirements.

Quality Control Chemist I (2015 2016)

Strategically steered results-generating API assay and related substance testing, Content Uniformity, Dissolutions, Blend Uniformity, and Cleaning Validation sample testing as per in-house, USP, or EP monograph. Delivered analytical support to process validation group, and initiated planned and / or unplanned deviation reports. Ensured seamless documentation of laboratory data, complete testing, data evaluation, and LIMS reporting.

  Proactively participated in SOP review and / or revision processes.

  Comprehensively adhered to company SOPs and practices GLPs daily.

  Continually identified improvement opportunities for Workgroup and QC.

Yyyyyy x. yyyyyy

Page Two ￨ (xxx-xxx-xxxx ￨ abc@xyz.com

Operator II

Played a vital role in facilitating Blending, Compression, and Granulation efforts, including collaborating with Pharma Techs and Quality Assurance on manufacturing investigations, as well as serving as the Shift POC for blend in-process sampling, bulk density, and particle-sized protocols. Participated in the validation of processes and new product process development. Optimized efforts within isolations areas requiring full gowning in protective apparel using PAPR or supplied air respirators. Led set up assembly and / or disassembly of production equipment.

  Successfully rewrote and / or modified production SOPs / BPRs.

  Performed all job functions per key cGMPs, SOPs, and DEA regulations.

  Gained company trustworthiness to work with Morphine Sulfate portfolio.

  Expertly performed in-process testing as required to monitor product operators.

Additional Professional Experience

Owner ￨ Manager J.C. Lawn Care, Xxxxxx, AL 2011 2014

Decontamination Technician Bartlett Nuclear, Inc., Burke County, GA 2011

Business Manager ￨ Car Sales Associate Classic Automotive Cadillac Jeep, Cullman, AL 2006 2008

Production Planner ￨ Scheduler B-K Manufacturing, Inc., Arab, AL 2005 2006

Medical Laboratory Specialist U.S. Army Research Detachment, San Antonio, TX 2004 2005

Construction Estimator Walker Building Supply, Inc., Arab, AL 1997 2003

Bachelor of Science in Laboratory Technology (3.15 GPA)

Undergraduate Chemical Engineering Studies

Professional Training / Development

PAPR Certified ￨ 24-Hour HAZWOPER Training ￨ 8-Hour OSHA Refresher

NUF RP Fundamentals Exam Browns Ferry Nuclear Plant (Passed 2013)

CPR / AED Certified ￨ Bloodborne Pathogen ￨ Fire Extinguisher ￨ Safe Start Training

Six Sigma Green Belt Certification ￨ Certified Trainer GMP / GLP ￨ Certified Project Reviewer

Military Training / Development

Military Occupational Specialty 91K ￨ Medical Laboratory Specialist

Advanced Individual Training (Medical Laboratory Specialist) ￨ Basic Combat Training

Viscometer ￨ Karl Fischer Titration ￨ pH Meter ￨ Analytical Balance

HPLC ￨ UPLC ￨ U3000 ￨ UV-Vis ￨ FT-IR ￨ Dissolution Tester ￨ Melting Point Apparatus

Microsoft Office (Word, Excel, PowerPoint, Outlook, Access) ￨ Empower3 ￨ STARLIMS ￨ MATLAB

Excellent Professional References Provided Upon Request

Yyyyyy x. yyyyyy

Xxxxxx, AL xxxxxx ￨ (xxx-xxx-xxxx ￨ abc@xyz.com

Date

Hiring Agent Name

Company Name

Address

City/State/Zip Code

Dear__________________:

I am exploring a new career opportunity within a challenging [ Insert Job Title ] role, and I believe that I can make a positive contribution to your success.

As a Certified Six Sigma Green Belt, I can offer proven experience in Quality Control, Laboratory Analysis, Multi-Project Management, Process Optimization, Team Building, Training / Development, Multimillion-Dollar Budget Control, Asset Management, and Cost-Reducing Initiatives. I am also well-versed in GMPs, SOPs, GLPs, HPLC, UPLC, ISO9001, IR-IR, UV-Vis, Reports Generation, and Regulatory Compliance, among other areas.

Currently, as a Quality Control Chemist II for Par Pharmaceutical, I expertly perform all facets of laboratory analyses, including facilitating product testing, stability testing, cleaning verification testing, and manufacturing in-process testing. Within this role, I successfully lead a top-performing team of researchers, including 2 chemists and 3 lab technicians in completing projects to minimize glassware contamination and effects on chromatography. I also perform lab method transfers and participate in method validation and verification studies while delivering laboratory support, including routine instrument cleaning and preventative maintenance.

A sample of recent accomplishments include:

  Successfully achieving 6 months with zero analyst-related (NOE) errors.

  Strategically managing a $1.5-million budget and overseeing $1+ million in assets.

  Grading 98.2% on-schedule product portfolios with 0.6% analyst-related (NOE) errors.

  Successfully participating in Six Sigma projects with HPLC column care and proper system care.

  Serving as leading analyst for testing spironolactone portfolio with 256 lots tested since 1 / 2017.

  Proactively adhering to manufacturing-centric regulatory, company, and compendial requirements.

  Achieving recognition by senior Endo management for work associated with HPLC column care and proper system conditioning, SOP rollout, and new hire training; company saved $370,000 in 2017.

To complement this experience, please note that I attained a Bachelor of Science in Laboratory Technology from Auburn University and completed extensive Undergraduate Chemical Engineering Studies at the University of Xxxxxx Huntsville. As previously mentioned, I hold a Six Sigma Green Belt Certification, and am a Certified GMP / GLP Trainer and Certified Project Reviewer, among other qualifications. I also successfully passed the NUF RP Fundamentals Exam (Browns Ferry Nuclear Plant).

As this is just an example of my abilities, please refer to my enclosed resume for additional quality control, business leadership, production planning, and medical laboratory specialist experience.

I am eager to discuss how my qualifications uniquely match your current and future needs, and look forward to interviewing with you soon.

Sincerely,

Yyyyyy x. yyyyyy