Technical Editor for Global Quality Standards Project
Supports Quality initiatives under Annex 11, Part 4 of the EudraLex; GxPs (21 CFRs) and specified Guidance for Industry guidelines governed by the FDA; Anvisa, EMA, Canadian, European Commissions, ICH, Japanese, PIC/S, USP-NF, and WHO Guidelines, etc. which include:
• Performs editorial reviews of Global Quality Standards (28 from Phases 2, 3 and 4 of project) at several points within the reviewing process.
• Ensures consistent style and format for all documents in accordance with Shire’s documentation practices and existing processes.
• Created a process for compiling and assessing comments for each Global Quality Standard (GQS).
• Completion of documentation and training plan submission forms for GQSs which are ready for processing within the approval workflow.
• Communicates key milestones and deliverables for each GQS including follow-up and active communication on issues and potential roadblocks.
• Assists in the revision of relevant Global Quality Standards (original 19 GQSs from Phase 1 of project) and, as appropriate, escalating issues and driving remediation of those issues.
• Maintains a list of key regulatory requirements per GQS and indicating how each regulatory requirement is being captured within the GQS.
• Create and maintain a list of glossary terms used throughout all of the GQSs to ensure a consistent use of terminology.
• Create and revise the Shire Global Quality Standard Glossary which will unify the use of key terms and their definitions throughout all of Shire Technical Operations globally.
• Maintaining and updating the Style Guide and Template for GQS creation.
• Creates the Gap Analysis tools for the implementation of each standard (35 from all phases of project).
• Participates on Gap Analysis Teams and helps with gap analysis (standard implementation) process, as appropriate.
• Organizes and maintains the SharePoint site
Technical Writer for the Exceptions Management Project
Shire – Lexington, MA
• Developed, authored, revised and reviewed cGMP documentation such as SOPs, appendices, facilitator guides, work instructions, job-aids, training guides and training presentations in a timely manner.
• Attended Kaizens and assisted along with a cross-functional team in creating a new triage process, robust risk-based deviation leveling tool, Augmented Sampling process, QC laboratory investigation process integration, Material Review Board (MRB) process, internal and supplier role-based deviation processes and TrackWise workflow data capturing system for deviations.
• Authored major revisions to existing deviation and investigation and nonconforming material review SOPs and assured timely rollout of documents to meet regulatory commitments and 2 instructional TrackWise SOPs for internal and external deviations.
• Authored 9 new SOPs for the new integrated deviation process that supports the needs of internal and external operations.
• Created tables and flow maps of new processes; sent final drafts for review to specified persons in functional areas; collected comments and created a process for compiling and assessing comments; held facilitated reviews, edited, formatted, sent documents through QD process to be made effective, created training presentations and assessment and completed training plans.
• Participated on Training-Subteam and TrackWise Training Subteam where assisted with creation and review of classroom training materials, PPT presentations for existing deviation and investigation SOPs, RCA Workshop and Role-Based Training Workshops creation and review of computer based training for the new deviation workflows.
• Project Lead for Impacted Documents Project where assessed the impact on 135 documents (SOPs, Standards, etc.).
• Assisted with Data Migration activities and test scripts for the PQ of the new TrackWise workflow data capturing system
•Responsibility to ensure all cGMP facilities, plant utilities, HVAC and Calibration & Metric – Preventative Maintenance Work Orders, Calibration & Maintenance, Corrective Work Orders and Emergency Work Orders are executed following quality and regulatory standards.
•Ensure personal objectives are aligned with site goals and objectives.
•Participate on audit teams for all Level 2, 3 and 4 Inspections.
•CAPA Effectiveness Checks.
•Initiate Deviations and drive to closure: Lead Quest Team Investigations, interview Subject Matter Experts (SME’s) and the users of the processes as well as conduct research and gather information for root cause analysis and assess product impact using WWWWHHW, Fishbone, 5 Whys and GEMBA walks as well as facilitate review and complete deviations
•Initiate Corrective and Preventative Action Plans and drive to closure in SAP: Write CAPA Plans in reference to deviations and stand-alone CAPA’s and facilitate task completion with task owners.
•Write Global and Local Change Controls: Work with Equipment Owners to write up Global and Local Change Controls related to building/site, systems, material, equipment, utilities, processes, critical master data, etc.: Enter Change Controls and related tasks in SAP, present Local Change Controls at weekly ICC Committee Meetings, and circulate Change Controls for approval.
•Manage and update departmental metrics for deviation and remark memo cycle time and other Key Performance Indicators.
•Write, revise, review and develop standard operating procedures, appendices, facilitator guides (Work Instruction Documents), training guides, performance qualification documents and knowledge assessments in a timely manner: Utilize SME’s, design specifications, users, system manuals etc. for guidance on each process, conduct research and have the ability to gather information to produce a clear concise document to the target audience, edit, proofread and format technical documents for business and consumers
•Responsible for accuracy, consistency, completeness and compliance of documentation within laboratory notebooks, records and reports.
•Responsibility to ensure all aseptic operations related to manufacturing equipment for Grade A/B/C/D areas are executed following quality and regulatory standards.
•Use of proper aseptic technique while performing tasks in the Grade A/B areas (routine aseptic interventions EM monitoring, addition of stoppers, etc.).
•Write, revise, review and develop standard operating procedures, appendices, facilitator guides (Work Instruction Documents), training guides, performance qualification documents and knowledge assessments in a timely manner: Utilize SME’s, design specifications, users, system manuals etc. for guidance for processes as well as conduct research and have the ability to gather information to produce a clear concise document to the target audience, edit, proofread, format technical documents for business and consumers.
•Communicate clearly and transparently within the department and across supporting functional groups. Deal positively to change and demonstrate ability to maintain high personal performance.
•Identify and recommend improvements to equipment, compliance systems, safety and productivity.
•Interact with equipment and automation systems while performing real time batch record documentation/ review, to contribute towards establishing efficient manufacturing.
•Ability to work independently with minimal supervision or as a team player while performing normal processes and procedures.
•Operate processing equipment in accordance with LSOP’s and site guidelines: Vial Washer, Depyro./ Steril. Tunnel, Automatic Vial Inspection Equipment, Autoclaves, Material Air Locks and utilize RABS technology
•Troubleshoot process equipment and work in conjunction with maintenance personnel when repairs are required.
Microbiology Peer Reviewer
Consumer Product Testing Company – Fairfield, NJ
Adhere to Good Laboratory Practices (GLP) and Good Manufacturing Practices (cGMP) under FDA regulation and International Organization of Standards (ISO):
• Responsible for the internal audit, by 100% inspection of study data, laboratory notebooks, records and reports for accuracy, consistency, completeness and compliance in a timely manner.
• Review and log in of batch/lot numbers for precursory and aftermarket products.
• Reporting, investigation and writing documentation for Out-of-Specification (OOS) test results.
Proficiencies related to:
• Reviewing all data and signing off on completion of accurate documentation for submission to clients under GMP and ISO standards.
• All core testing performed within the Microbiology Laboratory.
• The United States Pharmacopoeia standards.
• Understanding of inventory flow and control.
• Microbial Content: Total Bacteria Count (TBC)/ Total Yeast/Mold Count (TFC)
• Purified Water System Testing
Quality Assurance Analyst/ Auditor
Consumer Product Testing Company – Fairfield, NJ
Adhere to Good Laboratory Practices (GLP), Good Manufacturing Practices (GMP) and
Good Clinical Practices (GCP) under FDA regulation and ISO standards:
• Lead Auditor for yearly internal audits: Responsible for reviewing, researching, write up of memos/reports and deviations for areas that did not conform and for final written documentation of audit response and further investigation.
• Participate in the execution of CPTC quality systems and requirements within the Toxicology, Clinical, Microbiology and Analytical Chemistry laboratories.
• Periodic monitoring and auditing of laboratory operations and procedures to ensure compliance with CPTC quality systems requirements, Study Protocols, Standard Operating Procedures and the above stated regulations and guidelines.
• Review study data, documents, records and reports for accuracy, consistency, completeness and compliance in a timely manner.
• Assist in maintaining CPTC archive system.
Proficiencies Related to;
• Reporting, investigation and written documentation for Deviations, Corrective and Preventative Actions (CAPA’s), Out-of-Specification (OOS) test results and Adverse Events
Proficient in animal handling techniques in rodents and primates for preclinical drug safety (toxicology) evaluation studies, including;
• Dosing (oral gavage, IV, IP), Bleeding (lateral tail vein, vena cava, abdominal aorta and jugular) in rats.
• Dosing (oral gavage, Sub-Q) in mice.
• Dosing (oral gavage, naso-gastric), Bleeding (Femoral) in Non-human Primates.
• Clinical observations, body weights and cage-side activities in rodents and Non-human Primates.
• Biological sample collection for test article-carrier analysis.
• Online data collection [Provantis, Replacement Drug Safety System (RDSS)]
Proficiencies related to study conduct;
• Study leader; management of team assigned to work in my research studies.
• Operate in accordance with Good Laboratory Practices (GLP).
• Adhere to protocol study designs and coordinate a study calendar that best fits the research critical activities and results demand in a timely manner.
• Adhere to Standard Operating Procedures.
• Maintain detailed and accurate records as well as protocol documentation in laboratory notebooks.
• Verify computer data against manual raw data and generate daily computer reports.
• Communicate clearly and transparently within the department and across supporting functional groups.
• Training completed in core technical procedures and required equipment related to the performance of preclinical drug safety evaluation studies.
• Maintain laboratory equipment and supplies.
• Completed mandatory trainings related to: Quality Assurance/GLP, Laboratory Animal Safety, Allergy Prevention and Zoonosis.
• Continued training in Rat Orbital Sinus Blood Collection and Mouse Orbital Sinus and Aorta Blood Collection.
Animal care and husbandry responsibilities
• Perform routine laboratory animal handling and care.
• Perform facility husbandry and maintenance to ensure compliance with federal regulations.
• Maintain safe and clean primary enclosures used for laboratory animals.
• Inspect vivarium and address issues related to cage wash instrumentation, feed storage and general supplies.
• Animal husbandry/handling of rodents.
• Inspect feed and watering devices for proper functionality and sanitation.
• Observe animals, report and document apparent abnormalities and mortalities.
• Maintain detailed records and animal husbandry logs.
• Co-authored and reviewed Standard Operating Procedures (SOP’s).
Performed various laboratory techniques as per cGMP and SOP requirements including:
• Performed a variety of sample and standard handling tasks in support of the laboratory.
• Stability testing of Active Pharmaceutical Ingredient’s (API’s) and drug products.
• Nasal spray testing, pump delivery, droplet size distribution, spray pattern analysis.
• Osmolality, pH and Density testing of Nasal spray product.
• Prepared reagents and buffer solutions for use on HPLC analysis.
• Performed HPLC analysis for in process and final product samples.
• Responsible for reviewing, investigating and written documentation in response to consumer complaints.
• Responsible for removal of out-dated standard operating procedures and placement of current standard operating procedures.