Training Quality Control
Resume:
LORI MANICONE
Riverdale, NJ *****
Home: 973-***-**** ****.********@***.*** Cell: 973-***-****
SUMMARY
Highly motivated, confident and detail-oriented Analytical Scientist experienced in pharmaceutical analytical research, QC and QA with 20+ years of documentation, training and laboratory experience
Proven organizational/time management skills in a consent decree environment
Experienced in auditing documents for regulatory submissions, batch release & analytical method transfers
Motivated team player with excellent prioritization, training, laboratory analysis & communication skills
Integrity driven, understands importance and adheres to GMP/Quality and USP/FDA Regulation
PROFESSIONAL EXPERIENCE
INTERTEK USA, Inc. Intertek Pharmaceutical Services, Whitehouse, NJ
QA Auditor I Aug 2016 - Present
Reviews the analytical data package inventory: Analytical Report, Project Notebook Log, Project Notebooks, ADRC, Analytical Data Audit Trail, Customer Correspondence, Signed Proposals
Reviews internal records including Instrument Log Books, Calibrations, Training Modules and Employee Proficiency Log Books
Able to adhere to and perform in a regulated environment
Assign Quality Forms to laboratory
Responsible for removal, retrieval and documentation of controlled substances for lab analysis
AUSTAR PHARMA June 2015 - July 2016
Quality Assurance Specialist
Review, release & approval of documentation for OOS reports, CAPA's, USP Verification/Validation testing, SOPs, method transfer protocols, C of A's; batch record & notebook review (calculation checks)
Document Manager (archival/retrieval) of documentation(training/SOPs/batch/etc)
Prepare and send appropriate documentation to customers
Preparation, review and final approval of labels for packaging, clinical & commercial production
Issue lot numbers/Batch records and support APR's, review/approval of packaging and patient inserts to master
Enforce GMP/compliance and communicate with all levels of management in a regulated environment
UL EduNeering May 2015 - Dec 2015
Subject Matter Expert (work from home)
Review and improve content of UL e-learning standard courses with FDA CFR 21 part 210 and 211 sections
ACTAVIS PHARMACEUTICALS June 2013 - Jan 2014
Chemist Ill - Quality Control/QA
Dissolution, assay and CU of solid dose products (release & stability)
Troubleshoot instrumentation as needed (HPLC & Dissolution baths)
Review & approve dissolution, assay and CU reports
Leave of absence to attend to family matters April 2011 - June 2013
MERCK RESEARCH LABORATORIES (Schering-Plough) Aug 1992 - Apr 2011
Area: Research - Analytical Development/QA 1999-2011
Positions: Scientist I & Associate Scientist
Leadership Responsibilities
Responsible for cGMP laboratory preparedness for regulatory audits under Consent Decree
Trained analysts in complicated analytical procedures
Managed lab safety program. Initiatives reduced citations by on-time implementation of CAPA's
Routinely communicated results to senior management within project timelines
Training Group Responsibilities
Ensured Lachman/cGMP commitments met during Consent Decree
Organized, reviewed and directed training activities for Consent Decree commitments
Maintained curricula, assigned SOPs/quizzes to appropriate functional area and ensured due dates met
Verified SOP quizzes for accuracy, graded quizzes and did follow-ups for completion
Managed (filed/retrieved/distribute) training documentation (SOPs, calibrations, logs, etc.)
Documentation and Review Responsibilities
Managed regulatory documentation for SOP's, instrument calibrations and chemical inventory
Wrote/revised training documents, SOPs, analytical methods & method validation plans in a cGMP environment
Coordinated, organized & verified data from multiple scientists for regulatory submissions
Technical Skills and Responsibilities
Supported drug product development (cGMP and non-GMP environment)
Utilized PSD (sieving), microscopy, HIAC, IR to characterize API, and finished product (sterile; aerosols; DPI; oral suspensions) by analyzing research/stability samples
Testing of candidates by HPLC/UPLC, DSC, TGA, VTI, hERG, form. prep, solubility & stability testing
Development, validation & transfer of methods to QC; OOS investigations (production & stability)
SCHERING PLOUGH August 1992 - August 1999
Area: Quality Control
Positions: Associate Scientist/QA & Assistant Scientist /QA
Documentation and Review Responsibilities
Reviewed (QA) analytical data & authorized documentation for batch release, Certificate of Analysis
Wrote instrument procedures & training checklists
Reviewed & authorized training documents for analyst qualification
Reviewed C of A's (Certificate of Analysis)
Managed the chemical inventory program
Leadership Responsibilities
Responsible for laboratory audit preparedness. Facilitated lab/procedure/documentation improvements
Trained analysts in complex analytical procedures
Disseminated problems to supervisor
Support OOS/CAPA and complaint investigations
Technical Skills and Responsibilities
Thermal, spectroscopic & wet chemical techniques for release of raw materials, API, IPC, reference standard qualification/requalification, finished product release & stability for cGMP manufacturing
Lead investigator/analyst of product complaint & OOS samples
Analysis by HPLC, GC, FT-IR, KF, UV, PSD, & microscopy (API, raw materials & finished products (e.g. liquids, creams, ointments, tablets and dry powder inhalers) by USP and in-house procedures
Temporary Position - Analytical Development Aug 1992 - Aug 1993
Chromatographic testing of creams and ointments (API and finished product)
SANDOZ Drug Characterization - Summer Intern 1991
ADDITIONAL EXPERIENCE/SKILLS
HPLC/GC/TLC, UV/FTIR, dissolution, KF, HIAC, sieving, optical rotation; Empower; LIMS; MS Office
S2S Students to Science East Hanover NJ
Assisted crafts people with set up/ sales at shows; Retail experience at dept & grocery stores
Assisted scientific management in recruiting scientists at William Paterson University
EDUCATION & TRAINING: B.S., BS Chemistry, William Paterson University, Wayne NJ
AWARDS: Impact awards (Zetia audit, NDA Asmanex audit)
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