QA/RA

TRUDY TRICK

*** ********* **** * ************, MD 21030 t 443-***-**** t adhpuq@r.postjobfree.com

PROFESSIONAL EXPERIENCE

Aerotek Staffing at McCormick & Company, Inc., Hunt Valley, MD

Regulatory Compliance Contractor 2016-Present

Revise Nutrition Facts Panels for compliance with labeling reform using new version of DevEX and/or Genesis software.

Use SAP for various functions including setting up briefs to assign tasks for customers’ inquiries from the regulatory mailbox which I monitor.

Perform label graphics reviews in Blue software; versed in placement, fonts, types, identity, net weights, etc.

Weigh product samples averaging ten weights to get household measure.

Update claims in DevEX for gluten-free, tamper resistant, or other information. Pull reports for ingredient percent range breakdown, 100g nutrients and allergens and verify supplier data. Able to search by multiple codes, update tables, and request additional/revised data added to DevEX.

Provided information for Publix questionnaire, verified Great Value information between packaging and ASPECT database, and completed Kroger spreadsheets.

Completed thousands of Vermont GMO assessments ahead of schedule which was initial hiring purpose.

Paragon Bioservices, Baltimore, MD

Quality Assurance Associate III 2014-2016

Quality Assurance liaison for multiple clients’ projects from Process Development through GMP manufacture of clinical trial material (upstream fermentation and downstream purification) and IND filing.

Generated and verified vial labels and secondary container labeling.

Reviewed and approved material specifications and released raw materials.

Compiled and approved BOMs and master batch records.

Drafted Quality Agreement between client and Paragon.

Used tools like gap analysis and fishbone diagrams to initiate, write, and review deviations, investigations, and CAPAs.

Released executed batch records and ancillary documentation. Provided CoAs.

To meet customers’ requirements to deviate from a standard process, researched and approved risk assessments when necessary, i.e., to use material of animal origin.

Drafted the Change Control system SOP.

Presented cGMP training as required annually and for new employees. Compiled Good Documentation Training.

Performed internal audit of Document Control identifying deficiencies and risks.

Performed supplier qualification audits (requiring extended travel).

Identified opportunities for continuous improvement such as streamlining some processes.

UPM Pharmaceuticals, Inc., Baltimore, MD

Quality Assurance Associate 2013-2014

Used Documentum database to release reviewed batch records.

Initiated, wrote or reviewed relevant investigations, participated in CAPA resolutions.

Assisted in client, regulatory, and vendor audits.

Released raw materials and finished product after confirming analytical testing level (reduced or full), changed status in FormWeigh database, and labeled.

Filed monthly DEA ARCOS reports, procurement quota applications, executed 222 forms, registration renewals.

Performed AQL inspections, approved shipments, inspected and released labeling.

Documented environmental conditions (differential pressure, temperature, relative humidity) in GMP areas, downloaded all data loggers biweekly addressing out-of-spec readings.

Part-time DEA Consultant 2012-2013

Calculated and compiled controlled substance base amounts utilized and submitted monthly ARCOS reports to the DEA.

Verified year-end inventory of controlled substances and List I Chemicals for DEA year-end reporting.

Pack-It, LLC, Hunt Valley, MD

Quality Assurance Associate 2012-2013

Performed monthly GMP facility audits, reviewed reports with management, and assigned corrective actions to appropriate personnel, i.e. maintenance.

Completed batch record reviews and signed for release of products to ship each day.

Developed and utilized varying training methods (computer-based, one point lessons, newsletters) to suit the material (batch record updates, safety, cGMPs, etc).

Familiar with HACCP; the company achieved SQF Level 2 certification.

Conducted investigations for any rejected products.

Maintained physical separation of varying components (spice, packaging, finished product) especially allergens ensuring all were properly labeled.

Machine Operator 2011-2012

Operated and maintained Alloyd/All Fill machines, inspected and weighed blisters of spices.

Pii (Pharmaceutics International, Incorporated), Hunt Valley, MD

DEA Administrator 2008-2011

Assisted in audits by DEA, FDA and clients engaged in CDS manufacture.

In charge of daily controlled substance transactions including 222 forms, shipments, and inventory control for six registrations at three sites, wrote SOPs, and trained on handling.

Accessed vaults for manufacturing and maintained logbooks (for personnel and inventory).

Applied for procurement quotas based on signed contracts and maintained quota usage log.

Submitted quarterly ARCOS reports and year-end reports to the DEA.

Requested import and export permits according to availability of certain CDS.

Applied for federal and state registrations for all schedules of controlled substances needed and other permits as necessary including DHMH Distributor Permit.

Assigned NDC numbers, maintained log, and requested pseudo-NDCs from the DEA.

Provided weekly summary of CDS activities for management.

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