Becky Stryker - Quality Assurance Specialist,

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Work Background

Quality Agents, LLCSenior QA Specialist

Oct. 2024Expert in GMP and GDP exercising oversight of the validation of systems utilized in biopharmaceutical manufacturing including: o Equipment (Bioreactors, Chromatography systems) o Automation (Delta V, Control systems) o Utility systems (WFI, HVAC) · Review and approval of validation master / executed protocols and final reports · Review and approval of deviations for validation protocols · Review and approval of change control requirements, execution and completion · Review and approval of engineering drawings · Review and approval of TOPs

NovavaxAssociate Director of Validation, Interim

Aug. 2023 - Mar. 2025Gaithersburg, Maryland, United StatesI support management of qualification of manufacturing and lab equipment, facilities, utilities and shipping in accordance with regulatory requirements and support, follow and implement company manufacturing standards policies and procedures. Responsibilities include but are not limited to: • Serves as a technical resource or subject matter expert on methods and techniques within Validation. • Coordinates the global shipping validation program, including the plans, protocols, execution and final reports; internally and with global partners. • Manages day to day tasks for junior employees and supervisors. • Manages the contract staff to meet project requirements, including staffing levels. • Performs lead role on complex issues with minimal input from senior staff. • Approves Deviations, CAPA and Change Controls. • Manages the planning, development, execution, review, and approval of qualification and validation activities. • Delivers training for individual/small group/large group training. • Generates, reviews and approves controlled documents (i.e., SOPs, Technical Specifications, Protocols, Reports, etc…). • Manages projects and delivers outcomes within desired timeline. • Identifies and coordinates resources and effectively communicates process, outcomes and timelines. • Supports local and global Quality Assurance functions. • Serves as technical resource or subject matter expert for validation, including analytical / manufacturing equipment, facilities and shipping. • Manages and leads teams on complex GxP compliance events.

NovavaxValidation Specialist IV

Jan. 2021 - Aug. 2023Gaithersburg, Maryland, United StatesAs a Senior Validation Specialist at Novavax, I have managed several projects involving the initial set up of pharmaceutical manufacturing and Quality Laboratories involving the qualification of analytical equipment, facilities and shipping to GMP and FDA CFT Part 11 compliant standards. I have worked as and mentored other project managers in the process of moving entire laboratory departments from one space to another, while in a GMP controlled state, with minimal downtime for the departments. I am involved in audit and inspection readiness, data integrity reviews, and support all departments with any Quality Assurance related inquiries. I also manage and train validation new hires (FTE and contractors), delegate projects and assignments, review and approve in-house and vendor protocols pre and post execution for others, while executing my own assigned equipment. This work includes completing and reviewing deviation reports and CAPAs within our facility EDMS (LIMS) system. I am considered an expert LIMS user, and have worked with novice users to troubleshoot issues and improve their skills with this system. I have spent my time with Novavax making an extra effort to build cross-department relationships and opening communication pathways to make sure my team and I are working with efficiency and accuracy. This ensures minimal rework while providing our personnel with the support they require. I consistently meet and exceed both my personal and manager set goals, I have been nominated for and received 2 Rockstar awards for going above and beyond for lab users and have received a manager nominated SuperNova award for my attention to data integrity issues. I am as comfortable leading as I am following quality leadership and hope to use these skills in my next position.

Glasko Smith Kline (GSK)Validation Engineer

Oct. 2019 - Jan. 2021Rockville, MDAs a Validation Engineer at GSK, I worked to validate analytical (lab and manufacturing) equipment to GMP and FDA 21 CFR Part 11Compliant standards. I also work as a technical writer, responsible for writing, reviewing, and executing validation (IQ/OQ/PQ) protocols within the LIMS system. As part of this, I manage workflows in M-ERP, using Qumas (Document Control LIMS) and write Functional Requirement Specifications, IOQ, IOPQ and IQC Documents, Deviations as well as Final Reports. I frequently multi-task by working on different phases of several projects throughout the day which enables me to meet deadlines and timelines efficiently. I am also known for being helpful, patient and often am selected to train new Engineers.

MerckSenior Quality Assurance Specialist

Oct. 2018 - Oct. 2019West Point, Pennsylvania, United StatesAs a Global Auditing Business Process Specialist, I was responsible for maintaining assigned GMP auditing business processes and LIMS systems, including reporting reliable auditing metrics, supporting business processes and IT systems for auditing (End to End). This includes but is not limited to Business System Administrator support for LIMS Auditing System, maintaining the audit schedule, generating reporting metrics. It also involved training and assisting individuals with their custodial tasks and assigning their user access privileges.

AlconTechnical Writer

Jan. 2018 - Oct. 2018Sinking SpringAs a Technical Writer for the Technology Transfer Department, I serve as a Validation Engineer to expedite and manage technology transfers projects. I translate technical documents from German to English in order to compare and contrast procedures across many company sites around the world. I am responsible for scheduling and facilitating collaboration on projects as well as writing, editing and expediting SOP’s, IQ, OQ, PQ, Deviations, Nonconformance investigations, CAPA and final reports within the company LIMS system for the manufacturing and packaging departments.

Johnson and JohnsonScientist IV

Jun. 2017 - Jan. 2018LititzAs an Instrument Calibration and Maintenance Services scientist, within the Quality Lab I performed IQ, OQ, and PQ Validations on Equipment and Processes. This involved technical writing and reviewing instrument operation, calibration and maintenance documents as well as developing test methods and validation protocols and reports within the LIMS System. I performed and trained users on proper use and maintenance of lab equipment and served as a consultant to check for ISO 9000, ISO/IEC 17025 and ANSI/NCSL Z540-1 Compliance, managing and completing change control documentation and performing annual visual inspections of the laboratories, manufacturing, and packaging areas.

Mars SymbioscienceAnalytical Scientist

Aug. 2016 - Jun. 2017Germantown, MDServed in a cross functional role as a LIMS Specialist, a laboratory analyst, and Metrologist and Instrument Specialist for both Quality Assurance and Research and Development. I worked to develop and implement the Laboratory LIMS System to facilitate transfer to electronic notebook. I worked within the development LIMS and trained users on the live system as it was rolled out. I Maintained records for all routine laboratory, warehouse and packaging area monitoring as well as expedited Laboratory Incident Report Tracking and Investigations for the Quality Department. I prepared for Audits by Checking for ISO 9000, ISO/IEC 17025 and ANSI/NCSL Z540-1 Compliance. Also took a lead with Change Control Documentation and Equipment and facility Validations.

Eurofins Lancaster LaboratoriesChemist - Pharmaceutical Method Development and Validation (Metals)

Aug. 2015 - Aug. 2016Lancaster County, Pennsylvania, United StatesServed a dual role as a Validation and Data Review Specialist/ Pharmaceutical Raw Materials Trace Metals Method Development. Developed, wrote, performed, executed and reviewed method validation studies for testing Raw Materials as well as finished Excipient, API and Drug Products according to ICH, USP, NF, JP and EP/BP guidelines, per client requests.

Microbac Laboratories, Inc.Metals Analyst

Jul. 2012 - Jun. 2015Harrisburg, Pennsylvania, United StatesAnalyst working closely with Quality Assurance and Compliance to ensure procedures and analysts follow EPA, OSHA, Standard Methods and Safety guidelines leading up to and during EPA Audits; Instrumentation Expert (Use, maintenance, troubleshooting and repair). Also performed method development and Feasibility/LOD study updates for soil, water, paint, and tissue, per client request. Was a member of the “Employee Action Committee” focused on employee retention, safety, health and the environment. Acting team leader; training new analysts and mentoring employees on test methods, instrumentation, technical writing and review of SOP’s and troubleshooting the LIMS system to complete large projects using many test methods.