Laboratory Process Validation Associate, Research & Development

BioBridge Global is a San Antonio-based nonprofit, that integrates donor-to-patient services to enable the future of biotherapeutic solutions, including blood, tissue, and advanced therapies. Through our subsidiaries – South Texas Blood & Tissue, QualTex Laboratories and GenCure – we provide products and services in blood resource management, cellular therapy manufacturing, donated umbilical cord blood and human tissue, as well as testing of blood, plasma, tissue, and cellular products for clients in the United States and international markets. We also support the development advanced therapies by providing access to starting materials, testing services, biomanufacturing of cell and cell-based biologics and clinical trials support.We at BioBridge Global have been committed to saving and enhancing lives through the healing power of human cells and tissue for over 50 years. If you share our passion, join our team!BioBridge Global (BBG) (http://biobridgeglobal.org/subsidiaries) is a non-profit company that oversees and supports South Texas Blood & Tissue Center (STBTC), QualTex Laboratories, GenCure, and The Blood and Tissue Center Foundation. For over 40 years, our team of dedicated professionals has made life-saving connections. Our diverse services bridge critical medical industry needs with innovative solutions.Job Title: Laboratory Process Validation Associate, Research & DevelopmentRevision: 0000Job Code: 703782Shift: Monday- Friday 8:00am- 5:00pmFLSA: OT EligibleHybrid? NCPF Level: P2Location: San AntonioDept.: Research & DevelopmentBusiness Unit: BioBridge GlobalGeneral SummaryResponsible for the development of content in internally facing documents, such as Assay/Equipment Validation Plans, SOPs, Work Instructions, Job Aids, and Forms.Responsible for preparing samples for validation, analyzing and summarizing validation results.Monitoring and analysis of laboratory process operations.Design and analysis of laboratory experiments to evaluate and/or validate laboratory processes, which may include commercially and laboratory developed processes and assays.Maintain excellent communication with the Department and with Laboratory Services personnel.Commit to and abide by the character of BioBridge Global’s Core Values of Accountability, Stewardship, Pioneer, Integrity, Respect and Excellence (ASPIRE).Support, communicate and reinforce the mission and vision of the enterprise.Provide world class customer service by capturing and being responsive to the voice of the customer (internal or external, including donors for select positions) through multiple feedback channels in order to resolve issues and drive satisfaction in accordance with the BBG customer engagement, feedback, and complaint processes.Major Duties and ResponsibilitiesEssential TasksDevelops, or revises equipment/assay/process validation plan documents.Develops or revises production documents, e.g. SOPs, Forms, Job aids, flow diagrams and training documents impacted by validations.Team lead for validations, prepares samples as needed for validations and analyzes validation results in real time to identify any discrepancies.Support laboratory special projects as assigned.Manage tasks to completion and organize efforts to accomplish high risk/high priority actions first.Provides guidance and training as needed.Performs other duties as assigned.Non‐Essential TasksAssist in other laboratory areas as directed.EducationRequires a Bachelor’s Degree from an accredited college or university with major course work relative to the field of assignment.Licenses and/or CertificationsCategorical Certifications preferredLEAN and/or Six Sigma Certification preferredExperienceRequires two or more years of laboratory experience.Requires experience working in a regulated environment.Requires experience in the following areas‐technical writing, and validation documentation drafting, assay validation, equipment validation, procedural validation, training, updating SOPs, WI, job aides and forms.KnowledgeMust have a working knowledge of laboratory sciences, techniques, and equipment.Must have technical writing knowledge in pharmaceutical, hospital, clinical, laboratory testing, cGMP spaces.Must have knowledge on good documenting practices, cGMP, Master Control or similar programs.Must maintain knowledge of and perform according to Standard Operating Procedures (SOPs) and policies.SkillsMust produce documents with clarity, flow, organization, completeness, accuracy, readability, and appropriateness.Must maintain competency in laboratory skills for liquid and material handling.Must be capable of evaluating, interpreting and reporting accurate/valid test results by current testing methodologies.Must have experience using Microsoft Office applications including Word, Outlook, Visio, PowerPoint and Excel.Must have excellent written and oral communication skills.AbilitiesMust be a self‐starter and self‐directed worker.Must be able to keep information confidential.Must be able to work independently as well as in a team environment.Must be able to work with interruptions, meet deadlines, and perform accurate work and/or reports.Must be neat in appearance and well groomed.Must be professional, detail oriented, self‐motivated, innovative, creative, assertive, organized, communicative, and have the ability to work independently.Must have the ability to train others to a competent level.Must perform well in repetitive work situations.Working EnvironmentWorks in a well‐lighted air conditioned and heated laboratory/department.May be exposed to electrical, mechanical and chemical hazards and other conditions common to a laboratory environment.May be exposed to blood borne pathogens and other conditions common to a clinical laboratory environment.May have bodily exposure to refrigerator/freezer temperature, especially hands and face.Will work extended hours during peak periods.May be required to work any time of the day, evening or night during the week or weekend.Occupational Exposure Assignment‐Category IWe invest in our people by offering competitive compensation, excellent benefits, and the opportunity to work with the first blood center in America to receive the ISO 9002 accreditation!All Full Time Positions Qualify for an Affordable and Competitive Benefits Package to include: Competitive salary 100% Employer Paid Life Insurance 401(k) with Employer Contribution 100% Employer Paid Long-term Disability Plan Paid Time Off (PTO) 100% Employer Paid AD&D Extended Illness Benefits (EIB) 100% Employer Paid Employee Assistance Program Shift Differentials Group Health Medical Plan with prescription coverage Paid Holidays Variety of Voluntary Supplemental Insurances Incentive Compensation Plan Voluntary Dental Coverage Educational Assistance Program Voluntary VisionBioBridge Global and its subsidiaries are proud to be an Equal Opportunity Employer committed to providing employment opportunities to minorities, females, veterans, and disabled individuals. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability, protected veteran status, genetic data, sexual orientation, gender identity, or any other legally protected characteristics. For more information about your EEO rights as an applicant under the law, please clickhere (http://www1.eeoc.gov/employers/upload/eeocselfprintposter.pdf) . BioBridge Global maintains a Tobacco & Drug-Free Workplace