Quality Mgr. in regulated industries, Pharma, Med Device and Biotech

Summary

Self-motivated, driven Quality Professional to deliver on experience in the areas of Document Management, Quality Assurance Management, Medical Device, Clinical Support, Manufacturing, Supplier Quality and Training in a highly regulated industry. BSI Certified Lead Auditor, Certified ISO 13485:2016 and 9001:2015. FDA 21 CFR 820, MDR, ISO 14971, ISO 14155, MDSAP, Canadian Medical Device Regulations. Able to quickly become proficient in new software technology and can adapt to new situations and projects without difficulty. Enjoy a fast-paced environment with the ability to handle strict deadlines, while adhering to regulations and procedures. Support all levels of the business to ensure compliance, communicating with groups regularly, provide support and solicit feedback.

Skills

People Manger, Continuous Improvements, Gap Analysis, Compliance, Quality Event investigations, Leadership, Development, In Process and Final Inspections, Validation/Verification, Testing, Cost Saving initiatives, Training, BOM Management, Complaints, Manufacturing, Start Up, CMO, Internal and External Audits, Supplier Management, Lead Backroom for audits, KPI’s, QMS systems admin, Goal Planning, Disaster Recovery, Acquisition Doc Management, New product Introductory, Configuration Management, Lot Management, GDP, GMP, Project Management, Batch Record Management.

PHARMA: MEDICAL DEVICE/OTHER: Class II and III

Cold and Hot radioactive agents Needle free injections (combination)

Bladder cancer medication Cutting-edge light-based technologies for dental

Lung medication for end stage lung Cancer Prosthetic robotic ankle

IV Therapeutics (dialysis) Ultrasound

Cosmetics Automotive (Stereo)

Professional Experience

HTL-BMI Biotechnology – Canton, MA

Sr. Quality Specialist/Manager 06/2024 – Present

Manage all aspects of GxP Manufacturing, Quality Assurance and Documentation Management

Implementing Quality Systems metrics/KPIs

Back-up, Management Representative

Developed and manage training program (GxP) – Core Curriculum, Matrix, Groups and Identify key KPI’s (manage monthly metrics).

Manage all Quality Assurance programs for audit readiness.

Develop requirements for new QMS system, testing modules and providing any input to ensure compliance and ease of use. Create test scripts, Validation/Verification, Work Instructions and all documentation involved.

Oversee labels and template creation for consumables, raw materials, buffers, media and finished products.

Assist in developing Metrology Program with manufacturing and operations.

Assist in developing Materials Management Program with operations.

Initiate/Execute/Review/Approve - all Quality Events

Assist manufacturing and operations with CDC cert for ISO 5,7,8 clean rooms.

QA input to the Executive team on new product/client prospects.

Assist Manufacturing Management with the creation of Batch Records. Guidance on Regulations, flow, GDP and QA and Doc Control responsibility.

Cytrellis – Woburn, MA (Contract GCR)

Audit Readiness and Support 03/2024 – 04/2024

Support ISO 13485:2016, MDSAP Surveillance Audit – reviewed all documentation to make sure MDSAP and ISO requirements are present and concise.

Gap Analysis for SOPs, WIs and Records

Consult with QA group about recommendations, GAPs and corrections.

Investigated any non-conformances and started CAPA(s) to be sure issue(s) are resolved and documented.

Logistics for Front room and Back room for the 3-day audit, IT supported set up.

Audit was successful, no findings noted during Surveillance audit.

Lantheus – Billerica, MA 04/2022 – 12/2023

Manger, Quality Systems and Documentation

People Manger for Quality Systems and Documentation, 6 Direct reports

Manage employees, Mid-year and yearly performance reviews, balance workload, manage performance, staffing employees and contractors to meet business needs. Motivate and challenge staff to be their best, provide guidance and learning opportunities.

Collaborate with Quality Leadership to develop goals for Documentation Management team.

Simplify business processes and increase efficiency while staying compliant.

Own/Assist with quality event investigations – CAPA, Deviations, Temporary Changes, Change Control, SCARs

Onboard / Offboard employees in QMS system - reassignment of open items, determine CATSWeb license needs, and resolve IT tickets.

Manage Control Prints (Batch Records) for manufacturing floor – BR Matrices, disaster recovery plan, prints for floor (2 shifts)

Collaborate cross-functionally with teams to advance the capabilities and efficiency of documentation processes throughout the GMP environment.

Create/Monitor KPI’s and report monthly to Quality Leadership Team.

Document Control advocate and corrective actions as necessary to ensure the document change process is aligned with company policies and regulatory requirements.

Developed contingency plan to maintain critical functions in the event of power outage or disaster.

Maintain current knowledge of policies, procedures, systems, and external regulatory requirements.

Projects – ERP (manage all new and revising documentation through the DCR process) 500+ docs, MBR restructure (paper to electronic), documentation from Acquisitions, Electronic (paper free) 2024, Intranet pilot tester and change owner).

Support productions runs, Batch Record management, work with Tech Ops to ensure compliance and help identify process improvements or cost savings; Gemba walks, Quality Event investigations, compliance with PPE in specified areas.

Review/Approve, new and revising documentation to ensure compliance with Quality and Regulatory requirements.

Lead/Support Internal and External Audits – Back room and SME for Quality Systems, Documentation and Quality Events.

Assist/Monitor budget and headcount for department/business needs.

Cost saving initiatives – Reduced DCR cycle time from 110 days to 50 days. Reduced spending on offsite record retention, saving the company money in storage and retrieval fees.

Portal Instruments – Cambridge, MA 02/2017 – 4/2022

Manager, Quality Systems and Documentation

SW Validation and testing of the QMS and Document Control System.

Manage Open QA Items monthly meeting to review and discuss CAPAs, IAs, EAs, NCRs, ECOs, SCARs (Quality Events) to ensure moving toward closure. Track internal audit schedule, Vendor audit schedule, Suppliers, ECO KPI’s, Regulatory items, Feedback, Risk Management, New/Outstanding action items.

Origination, Implementation and Releasing of Engineering Change Orders/Change Control

Maintenance of the Equipment items to include prompt calibration, report on OOT (out of tolerance) and OOS (out of scope) items. Work with Equipment manager to resolve any issues and non-conformances.

Compilation of quality metrics to support quarterly Management Review, run meeting in absence of VP of QA/RA.

Support IND submissions, FDA and Governing body responses, notify regulatory agencies when applicable to regulatory requirements.

Champion process improvements as business needs arise, from metric outcomes and during Periodic Review

Omnify administrator – add/remove users and assign specific licenses. Maintain Omnify as needed to accommodate business needs. Test updates to PLM/QMS system and add to production once validation/report are approved.

Owner and support for Internal/External audits, CAPA’s, Deviations, Temp Deviations, Supplier Deviations and Complaints. Investigate open items as determined, root cause analysis, corrective action, implementation, finding effectiveness and closure. Assign items to the correct department as needed.

Creation, Revising and Maintenance of Standard Operating Procedures, Work Instructions, forms and templates, company power point template and other documentation needs.

Assign all training/quizzes to employees and track in Omnify to completion. Monthly metrics reported in quarterly management review. Provide weekly reports to company. Report to Sr. Management any non-compliance.

Set yearly goals for the department and support staff to obtain department goals as well as their personal goals within the company. Align department goals with overall company goals and deadlines.

Yearly performance reviews for Document Control. Provide feedback to leadership on colleague’s performance when solicited during review process.

Develop training materials and train users on the PLM/QSM system as well as GDP (Good Documentation Practice), QA in a Regulated Industry and Quality Orientation.

Projects as they arise for business needs or as assigned by Sr. Director or VP of QA/RA – Successfully Revised Training program, Vendor certification tracking management, Training File management, Supplier outstanding QA items management, implemented a new revision of Omnify and rolled out training, Equipment management improvement and implemented a robust receiving process with QA Engineer.

Approval of vendors and maintain certifications, legal documents, Agreements, Audit documentation and or questionnaires. Support Purchasing A/R and A/P with any Purchase Order discrepancies.

Management Representative, lead front room for 13485:2016 surveillance audit.

13485:2016 audit preparation (surveillance/certification)

Manage all standards (guidance documents), maintain BSOL subscription.

Lot management and release of all controlled inventory. Batch record review (CM)

Support staff and encourage training and growth opportunities within the department/company.

Taris Biomedical – Lexington, MA (Consultant 6-month contract – Aerotech) 04/2016 – 10/2016

Product Development/Engineering Document Specialist

Preparing, reviewing, and maintaining documents and regulatory submission components for Product Development (PD) Group.

Review PD documentation for integrity, route for approvals and completeness through the Change Control System. Assist with writing Change Controls for initial entry to the review board as needed.

Maintain all databases for PD including training, Purchase Orders, Part/DWG/Protocol/Labeling/Specifications, SOP’s, Work Instructions, Approved Vendor List, Change Controls, Contracts for Vendors, Calibration, Protocols and Preventive Maintenance.

Manage all New, Revised and Released documentation that are controlled. (Product related and GxP)

Order lab supplies for product development builds (GLP), GMP builds and raw materials. Obtain Quotes, fill out purchase orders and submit for purchase, follow up with vendors for deliverables and any issues. Getting all CoC (Certification of Compliance) and supporting documentation together from vendors. Incoming inspection of all materials delivered for PD.

Develop, Maintain and Schedule calibration for all lab equipment per the manufacturer’s instructions/recommendations.

Develop, Maintain and Schedule Preventive Maintenance and any equipment out of order, according to manufacturer’s recommendation/instructions.

Developed Training Program – Core Curriculum, Training Matrix, Individual Plans, Grouping for QMS system.

Lead in backroom for ISO 13485 audit Phase 1 and 2

Assist Quality on process improvements and harmonizing their records with Product Development

Assist Engineering and Scientists with all documentation during all phases of GMP or New Development

Assist with phase II ISO 13485 audit – working with Quality, Regulatory and PD to create, update and build robust and efficient systems.

Part of quality team to help choose a software system to advance the company into electronic systems for Quality, Document Control, Lab, Clinical, Risk Analysis, Quality Events, Equipment and Maintenance.

Manage batch records and Laboratory notebooks, create Bill of Materials (BOM) for products being developed for GMP.

Fresenius Medical Care – Waltham, MA 05/2015 – 04/2016

Corporate Sr. Documentation Specialist

Verify, Implement and Checker on all product CN’s as well as Corporate Documentation CN’s.

Lead high level CAPA team to investigate and determine root cause of labeling issues throughout the company. Worked with Labeling Manger to update processes within Corporate, all plants and distribution centers to have clear concise SOP’s and WI and be harmonized.

Lead several projects such as pallet changes to 56 BOM’s and related documentation for one of our plants, process improvements to SAP SOP’s and Create Work Instructions for all related SAP requests and responsibilities. Took over SAP requests and was able to get the turnaround time from 3-4 weeks to 24-48 hours. Researching and adding all missed IFU’s on our company website (sending information to vendor to upload to website).

Responsible for the SAP requests e-mail. Requests include – Material Master New Part Set-up, Material Master Changes, Discontinuance and Substitutions, Sales View set up for other plants, Material Price Changes, Material Holds, ePedigree, year-end Cost updates, Spare Part Set-up and Implement other requests as needed or direct to appropriate department.

Back room audit support during audits – FDA, ISO and Vendor Audits.

Bose Corporation – Framingham/Stow, MA 12/2013 – 05/2015

Configuration Analyst

Participate on Product Development teams to facilitate the creation of new data.

Guide and support Product Development teams on the creation, release to Manufacturing and

Change Management of product data.

Analyze requested product design changes for accuracy and completeness.

Determine the effect on end product design data and prepare Engineering Change Notice

process documentation while ensuring adherence to (CM) Configuration Management Policies

and Procedures.

Own and manage the ECN process phase of change documentation, approvals, documentation incorporation,

manufacturing implementation, auditing, and completion.

Prepare and present reports for status of open ECN’s, ECN cycle time and quality of ECN’s. Presented in

weekly material meetings.

Prepare reports for ECN validation – Where used, CASS (SAP plant, costing and purchasing information) and

Material Impact (BOM changes).

Work with Engineers to release BOM’s / Parts to manufacturing for planning, prototyping, production, and sales.

Manage data extension priorities per program build schedules (NPIP).

Communicate with all individuals to quickly resolve issues, keeping all involved groups in the loop.

Provide Windchill training and SAP reporting capabilities.

Work with Data Process Managers on continuous process improvements.

Computer/Machine Experience:

MS Office Suite

Nova Web Administrator

Oracle

QuickBooks

SAP

TSS/RSS

eMatrix

IFS (ERP) Administrator

NT

Drop Box, Internet, office equipment

eDMR (QMS)

MS Dynamics

Outlook/Lotus Notes/Google

Adobe Acrobat Pro

Adobe Illustrator

Syteline

Windchill10 (out of the box and custom)

SharePoint

FULL ME 10 Co-Create

Compliance Wire (training system)

QT9

Omnify Administrator (PLM/QMS)

Google sheets

Lucid Charts

Agile Scrum

File Manager/Explorer

Design Gateway

Slack

Document Compliance

SQL – beginner

CATSWeb (QMS)

TEAMS

UKG

Summit (IT)

ENNOV

PTC Arena (QMS)

Certifications:

Arizona State University – Configuration Management II (CMII) Certification

BSI Lead Auditor Certification, 13485:2016 and 9001:2015

BSI Certification, 13485 and 9001

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