LORI MANICONE

Riverdale, NJ *****

Home: 973-***-**** ac2slf@r.postjobfree.com 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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