Experience

Pharmatech Associates, a USP company

• United States
• Pharmaceutical Manufacturing
• 1 - 100 Employee

• Compliance Specialist

  • Feb 2022 - Present

• Compliance Specialist

  • Jul 2021 - Feb 2022

• Technical Writer

  • Feb 2021 - Jun 2021



Operations & Quality Systems Improvement Experts (OQSIE)

• United States
• Business Consulting and Services
• 1 - 100 Employee

• Quality Data Integrity & CAPA Specialist

  • Jul 2020 - Jul 2021



The Nature's Bounty Co.

• United States
• Manufacturing
• 700 & Above Employee

• QC Supervisor

  • Mar 2018 - Jul 2020

  • Management of a team of 24 laboratory personnel to maximize workflow and performance while maintaining compliance. • Supervision of daily laboratory activities to prioritize and ensure timely testing & release of raw, in-process and finished materials, maintaining department KPIs. • Compose, review and approval of lab investigations, deviations and CAPAs. Provide guidance on risk-benefit assessments for product dispositioning.• Review, analyze and approve sample data for compliance with specification for analytical chemistry and microbiology teams. • Liaise with multiple departments for material release status and cross-functional team projects. • Assists with lab audits for compliance.• Review of CoA for compliance.• Creation and implementation of a new scheduling system and subsequent organizational changes.• Serve as subject matter expert for regulatory requirements within QC Lab and for material review board discussions on material investigations.• Provide mentoring in ethical behavioral expectations and the importance of data integrity of working in a regulated industry.



DPT Laboratories

• United States
• Pharmaceutical Manufacturing
• 300 - 400 Employee

• Quality Control Supervisor

  • Jul 2014 - Jan 2017

  • Supervised daily activities to ensure timely release of raw materials & components (chemical and packaging) to meet productivity, quality and teamwork metrics. • Managed personnel to maximize staff performance and objectives. • Responsible for the review and strict adherence to quality regulations (cGxP practices and QSM) including company SOPs, testing procedures and protocols. • Participation in audits by clients and regulatory agencies FDA/EMA/USP.• Created, updated and implemented documentation including SOPs and analytical test procedures, technical reports, specifications, change controls and other quality records (deviation investigations and CAPAs). • Facilitated the introduction of new chemicals in accordance with regulatory guidance by overseeing the creation of specifications in alignment with USP/EP and validated testing methods, preparing regulatory compliance statements, review of DMFs and other ANDA supporting documentation. • Assisted the regulatory team with QC portions of ANDA, PAS, CBE-30 submissions as well as Quality responses to deficiency and comment letters, all within strict timelines. • Coordinated and managed project deliverables for internal and external customers on the quality aspects of regulatory projects, serving as liaison between Quality and Regulatory teams. • Applied technical expertise on cross functional teams with internal departments on process improvement opportunities.



Noven Pharmaceuticals

• United States
• Pharmaceutical Manufacturing
• 400 - 500 Employee

• Quality Control Supervisor

  • Mar 2013 - Jun 2014

  • Managed laboratory personnel maximizing workflow and performance standards by coordination and supervision of daily laboratory activities ensuring timely release of raw materials, in-process materials, finished products, and stability samples to maintain department KPIs. • Monitored and evaluated various productivity, quality and teamwork metrics and help meet organizational goals. • Served as subject matter expert within an analytical laboratory environment and led investigations involving OOS/OOT results and deviations from established testing procedures (while adhered to strict GMPs and complied with a wide array of company SOPs and cGxP).• Responsible for performing professional and technical laboratory functions while helping to train and mentor analysts by using communication skills to transfer knowledge to entry-level employees.• Reviewed data, released completed materials, worked on method transfers, maintained annual product review files, assisted with implementation of paperless LIMS, and assisted with inventory of controlled substances safe. • Oversaw and assisted with instrument calibrations, provided technical support, conducted lab audits and safety inpsections. • Participated in a Six Sigma project to effectively reduce OOS and OOTs in the QC laboratory. • Participated in a project to introduce LIMS system to laboratory by assisting to develop paperless notebooks and execution of PQ validation studies • Authored, revised, and implemented technical documentation (protocols/reports, and procedures).

• Sr. Scientist

  • Jan 2013 - Mar 2013

• QC Scientist

  • Jan 2011 - Jan 2013

• Associate Scientist

  • Jan 2008 - Jan 2011

• Assistant Scientist

  • Mar 2004 - Jan 2008



Andrx Corporation

• United States
• Motor Vehicle Manufacturing

• Research & Development Chemist II

  • Jul 2003 - Nov 2003

  • Duties involve performing dissolution on solid dose products.• Preparations of assays and related compounds for HPLC analysis.• Performing a variety of USP monograph tests on raw materials, including tests such as LOD, Heavy Metals, Limit tests, etc.• Preparation of buffer and standard solutions. • Duties involve performing dissolution on solid dose products.• Preparations of assays and related compounds for HPLC analysis.• Performing a variety of USP monograph tests on raw materials, including tests such as LOD, Heavy Metals, Limit tests, etc.• Preparation of buffer and standard solutions.



Elan

• 1 - 100 Employee

• Chemist II

  • Oct 2002 - Jul 2003

  • Responsible for the physical and chemical analysis of transdermal units.• Duties involved performing an extended amount of routine and non- routine testing on raw materials, works in progress, finished products and stability samples.• Assay preparations included testing of potency and content uniformity via HPLC, residual solvent content via GC, dissolution of solid dosage material analyzed by UV/VIS Spectroscopy to determine drug content, physical testing of materials utilizing Instron (for peel and adhesion testing), TMI Probe Tack Tester, Viscometer, Micrometer, Sheer tester and FT-IR.• Initiation and documentation of laboratory investigations and review of data.• Experience in all aspects of FDA approved pharmaceutical industry which includes validation, sampling, investigation, research and development, stability and analysis.



Mediatech, Inc.

• IT Services and IT Consulting

• Quality Control Technician/Tissue Culturist

  • Oct 2000 - Aug 2002

  • Responsible for all tissue culture and functionality testing of growth promoting media for both insect and mammalian cell lines.• Performed microbiological testing procedures such as sterility and stasis testing, according to USP XXIV.• Duties included performing tests such as Endotoxin detection using LAL enzymatic kits, bioburden testing, powder moisture content testing and microbial inhibition testing of antibiotics.• Responsible for the maintenance of general laboratory equipment such as pH meters and osmometers.• Other duties involved composition and updating of SOP’s, training of personnel in various testing procedures, visual inspection of products and auditing of records.