SUMMARY:

• To obtain a challenging leadership position applying creative problem solving and lean management skills with a growing company to achieve optimum utilization of its resources and maximum profits.
• Science professional with experience demonstrating management, organizational, and research skills.
• Able to communicate and network with all types of people.
• Experienced at reviewing, analyzing, and developing programs.
• Excellent communication skills
• Research experience demonstrating critical thinking and problem solving ability.
• Professionally developed and enforced the concept of teamwork in accomplishing goals.
• Proven ability to work independently, organize and prioritize with minimal supervision.

TECHNICAL SKILLS:

PC literate with: strong MS Office, LabelView 2014, and Adobe InDesign experience.

PROFESSIONAL EXPERIENCE:

Confidential, Ogden, UT

Director of Quality

Responsibilities:

• Manage team of 3 - 9 employees (i.e. document control/quality specialist, QC technicians)
• Received NSF/ANSI 173 GMP Certification for dietary supplement manufacturing.
• Audited by NSF/ANSI for 455 GMP Certification for Dietary Supplements, OTC and Cosmetic products. Recognized by the Global Retailer and Manufacturer Alliance (GRMA).
• Preparation of protocols for equipment qualifications, manufacturing process validations, cleaning/allergen qualifications/validations.
• Setup and mange the supplier qualification system as well as for the regulatory document system for all raw ingredients.
• Prepare standard operating procedures for new equipment and new processes (e.g. hand sanitizers, gummy manufacturing) as well as for encapsulated and powder products.
• Manage and process deviations and change requests to update batch records and MMR’s
• Review and approve master material samples, material and inspection specifications/records and label/carton reviews.
• Oversee QMS for startup and manufacturing of OTC and Cosmetic products (i.e. hand sanitizer, topical ointments)
• Manage and prepare customer complaints and CAPA reports and oversee completion of corrective/preventive actions.
• Review and approve laboratory test reports and COA’s for incoming ingredients and finished product.
• Perform internal audits ensuring compliance to internal procedures and cGMP’s
• Manage document control, batch record preparation, training, and other quality processes.
• Setup of the HACCP/HARPC program for manufacturing process.

Confidential, Ogden, UT

Document Control Mgr./Asst. Quality Mgr.

Responsibilities:

• Manage team of 6 - 12 employees (i.e. document control specialists, batch record coordinator, technical writers, training administrator, QC techs)
• Manage equipment qualifications, manufacturing process validations, cleaning/allergen qualifications/validations and equipment calibrations
• Prepare standard operating procedures for new equipment and new processes
• Manage and process deviations and change requests to update batch records and MMR’s
• Review and approve master material samples, material and inspection specifications/records and label/carton reviews
• Manage product quality reviews and formula approvals.
• Directly involved with customer and regulatory audits (e.g. FDA, TGA, GFCO, NSF)
• Manage and prepare customer complaints and CAPA reports and oversee completion of corrective/preventive actions.
• Review, approve and assist in laboratory and environmental OOS investigations
• Perform internal audits ensuring compliance to internal procedures and cGMP’s
• Manage document control, formulations, batch record preparation, training, and other quality processes

Confidential, Salt Lake City, UT

Director of Quality Assurance

Responsibilities:

• Manage and maintain QMS ensuring compliance to FDA 21 CFR 820 regulations.
• Performed annual management review meetings.
• Manage and supervise document control system.
• Perform training for document updates within the Quality Management system
• Perform internal / supplier audits ensuring compliance to internal procedures and 21 CFR 820.
• Review and approve inspection reports on incoming materials and final assemblies.
• Implementation of new materials into current medical device.
• Manage CAPA, SCAR, NCMR and Customer Feedback processes.
• Manage FMEA for user, process and product design.
• Write justifications / rationale for NCMR’s, CAPA’s, Customer Complaints.
• Manage routine LAL and VDmax Dose Audits for product lines.
• Review and approve production work orders, document change orders, NCMR’s
• Assist with 510(k) submission for changes in indications for use.
• Write letter to file for product changes in design and material.
• Obtain Certificates to Foreign Government and authentications from US Department of State to get product into foreign markets.
• Worked directly with Australian TGA to get product into Australia.
• Worked with Regulatory Affairs to change CE mark for changing component materials and indications for use,
• Worked with marketing to create product label, IFU’s and packaging.

Confidential, Salt Lake City, UT

Quality Assurance Manager

Responsibilities:

• Highly involved with cross functional team to successfully bring a new material from idea to implantable medical device.
• Implemented and managed the company document control system (PDM).
• Managed and performed internal, DHF, and supplier audits ensuring compliance to FDA 21 CFR 820 and ISO 13485 regulations as well as to internal procedures. Directly involved in FDA and BSI Notified Body audits
• Directed and managed CAPA and Customer Feedback Processes.
• Wrote justifications for NCMR’s, CAPA’s, Customer Feedbacks, etc.
• Perform Design, Process and User FMEA .
• Directed biocompatibility testing for new material for spinal implants.
• Directed cleaning and steam sterilization validations for surgical instrument systems.
• Directed gamma sterilization validations and dose audits, cleaning and packaging validations for sterile implants.
• Reviewed and approved equipment qualifications, production work orders, document change orders, NCMR’s.
• Worked with Regulatory in compiling Technical File for CE.
• Worked with vendor to implement software for Quality Management System.

Confidential, Salt Lake City, UT

Validation Microbiologist, Quality Assurance

Responsibilities:

• Qualified laboratory equipment (FT-IR, Melt Flow Indexer, refrigerators, and incubators).
• Managed EtO sterilization microchallenges for annual qualifications, validation of a new process challenge/master product device, and validation of a low gas weight cycle.
• Managed radiation sterilization ANSI/AAMI/ISO dose audits. Also involved with radiation dose setting of new product.
• Involved in formal investigations for EtO residual failures, sterilization cycle excursions, particulate contamination, and determination of corrective and preventive actions.
• Performed routine laboratory testing (FT-IR, GC, sterility, and pyrogen)
• Prepared final laboratory reports, revised and implemented plant BOP’s, trained employees.

Confidential, Salt Lake City, UT

Research Assistant

Responsibilities:

• Assisted senior scientists in assay and method development for a high throughput screening system.
• Managed the operation and maintenance of automated laboratory instruments (96/384 tip liquid handlers, plate readers, robotic arms, and CCD fluorescence camera)
• Performed molecular tests such as PCR, DNA isolation and quantitation, gel electrophoresis, transfections, transductions, and assays using fluorescence and absorbance.
• Responsible for performing data analysis and generating reports for presentation to other business units for project coordination.
• Also responsible for developing SOP's used for employee training.

Confidential, Salt Lake City, UT

QA Laboratory Technician

Responsibilities:

• Qualified laboratory refrigerators and incubators used to store materials and reagents used for product release testing.
• Managed microchallenges for annual qualification of EtO and steam sterilization cycles.
• Managed quarterly AAMI dose audits for radiation sterilization.
• Managed the environmental monitoring program for medical device manufacturing clean rooms.
• Performed routine laboratory testing (pyrogen, APTT, particulate, sterility, inhibition testing, environmental monitoring, bioburden, and preparation of ATCC stock cultures)
• Performed laboratory investigations, prepared exception documents, prepared final laboratory reports, revised and implemented plant BOP’s, problem solving, and trained new employees.

Confidential, Salt Lake City, UT

Laboratory Technician

Responsibilities:

• Performed DNA/RFLP analysis on transgenic plants and animals, which included hybridizing radioactive P32 to DNA probes, performing PCR, and operating the 377 DNA sequencer.
• Coordinated projects between business units to ensure timely completion and delivery of test results.
• Implemented and revised standard operating procedures and actively involved in employee training.
• Prepared agarose gels, performed southern transfers, data entry, and reagent preparation.
• Worked with and ensured proper disposal of hazardous materials.

Confidential, Ogden, UT

Assistant Manager (Shipping & Receiving)

Responsibilities:

• Developed and maintained professional relationships with suppliers, sales managers, and business units as well as negotiate to effectively provide support to the organization.
• Managed the flow of inbound/outbound packages & freight (domestic and international).
• Managed shipping / receiving activities to ensure accuracy of receipts and completeness of incoming materials and outgoing products.
• Managed monthly & annual inventory count verifications and resolved discrepancies.
• Actively involved in hiring full time and temporary employees and scheduling during peak sales.
• Operated office machinery and heavy equipment and assisted with daily activities.