Sara Hendricks Email & Phone Number

Dublin, Oh, Us

Dublin, Oh, Us

Working on a Graduate Certificate in Data Science through Regis University - started 01/2020Quality Systems Manager - Cannoid LLCASQ Certified Quality Auditor (2016-2019)

Denver, Colorado, Us

Reviewed requirements for certification and initiated Pest Control, Environmental Monitoring and Shelf Life planning.

•Investigated Discrepant Material and issued Corrective Action/Preventative Action (CAPA) and Non Conforming Product Reports as required per ISO 13485 and other Quality System Regulations (QSR).•Interacted with Medical Device Customers to ensure Quality Expectations were met.•Qualified new suppliers per MultiSource Mfg Quality Management System (QMS) and ensured customers were notified in a timely manner of any supplier changes. •Wrote and executed retrospective validation protocol and report in response to FDA 483 finding.

• Managed the validation of a new USP Purified Water System, including but not limited to; monitoring vendor Site Acceptance Testing (SAT), writing User Requirement Specifications (URS), Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) protocols and reports per current Good Manufacturing Practices (cGMPs) to satisfy Regulatory requirements.

Phoenix, Arizona, Us

• Notified customers and regulatory agencies of product recalls that were subsequently documented in Trackwise, a Quality Management System used for corrective action and quality trending. • Consulted with Subject Matter Experts (SMEs) in on Define, Measure, Analyze, Improve, and Control (DMAIC) evaluations of process and product deviations including root cause analysis to ensure continuous improvement of laboratory and production processes.• Managed proficiency testing program for four laboratories to maintain CLIA compliance.

Phoenix, Arizona, Us

• Managed implementation of various aspects of the ALYX Apheresis equipment including, but not limit to; writing and completing the Equipment Lifecycle documentation, writing and executing the IQ, OQ and PQ protocols and reports, review of Standard Operation Procedures (SOPs) and the Process Performance Qualification (PPQ) associated with the equipment. • Developed SOPs and trained Operators on the validated use of equipment and ensured that software changes were qualified per 21 CFR Part 11.

Santa Clara, Ca, Us

• Slashed the requirement for yearly re-qualification of Controlled Temperature Units (CTU) by over 50% through collaboration with department owners to conduct risk assessments on the criticality• Audited cGMP equipment change control, temporary change control, deviation and unscheduled maintenance records for over 100 pieces of equipment to ensure compliance with quality systems and regulatory requirements. • Wrote and executed validation studies and SOPs in support of engineering, manufacturing, process development, facilities and quality assurance to ensure Regulatory requirements were met. Resolved CAPA’s and change controls related to validated equipment, software and processes.

Indianapolis, Indiana, Us

• Provided technical writing expertise to create and enhance SOP’s, batch records and other controlled documents necessary for cGMP operations and New Product Introductions (NPI). • Functioned as a project manager, coordinating reviews and approvals of cGMP documentation to meet production timelines and regulatory requirements and created library for software documentation. • Worked with Research and Development (R&D), Regulatory, Quality and Manufacturing on NPI’s to ensure that batch records and other documents were accurately transferred from R&D to Manufacturing.

Centennial, Co, Us

• Project Manager for the operation and validation of a $1.5 million USP purified water system.- Spearheaded chemical testing methods for in-house water testing saving $50,000 in fees.- Trained and mentored water system operators and provided oversight of outside contractors.- Subject Matter Expert (SME) during successful New Establishment Inspection conducted by FDA.• Project Manager for Plastic Packaging Radiation Sterilization validation.- Ensured consistent quality of sterilization by establishing dose audit program for packaging.- Collaborated with supplier to improve quality of packaging material exposed to radiation.- Converted packaging irradiation dose audit from ISO 11137 Method I approach to AAMI TIR verification (VI)max approach, resulting in significant cost savings. • Process Improvement Engineer – Demineralized Bone Matrix (DBM) Department.- Investigated and addressed customer complaints resulting in a better product. - Designed experiment to obtain more uniform particle size for more consistent DMB putty.

B.A., Mcd Biology And Chemistry (Bio)

M.S., Environmental Sciences

M.S., Chemical Engineering