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_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.

General Summary

Responsible for providing technical expertise in the development and continuous improvement of commercial testing laboratory processes. 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, assays equipment and facility designs. Maintain knowledge of and assist with the authoring of relevant standard operating procedures. Maintain excellent communication with the Department and other Laboratory Services personnel. Able to work effectively and facilitate equipment moves in partnership with project managers to ensure successful collaboration and equipment relocation and verification and/or validation. Professionalism and diplomacy in dealing with other Departments is necessary. Responsible for providing support as needed with SOP updates work instruction creation, process flow charts, and tracking progress of various document reviews.

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.

It is essential that the incumbent have a valid driver's license and be at least 18 years old with a good driving record to meet organization driving standards.

Major Duties and Responsibilities

Essential Tasks

Independently design, execute, and interpret results for laboratory experiments/validation studies to evaluate and/or validate laboratory processes, test methods equipment and facility designs., which may involve the implementation of highly complex testing machinery.

Create, Draft, Update, and Edit Validation protocols that would be acceptable by auditing agencies or clients.

Train staff on validation protocols.

Manage incoming validation tickets via the ticketing system to ensure validations are assigned and appropriate information is provided prior to drafting any documentation.

Maintain adherence and assist with the development of project plans and budgets.

Establish operating parameters and quality control limits as required.

Assisting with the resolution of quality improvement investigations/CAPA implementation, quality event initiations and tasks completion, equipment malfunctions and other technical problems. Maintain strict adherence to Standard Operating Procedures (SOPs).

Prepare and maintain reports/records and perform computer data entry.

Assist with training and/or mentoring of new employees and/or volunteers.

Participate and/or lead team-oriented work projects for the development and implementation of validations, process improvements, and Standard Operating Procedures (SOPs).

Assist in other areas as directed.

Function as a project coordinator to ensure adequate resources are allocated for the execution of each validation. This includes but is not limited to coordinating with resources managers from each business unit as well as support service units to confirm resources are allocated well in advance to ensure seamless execution of validations.

Provide knowledge and expertise on relevant scientific principles, which may require authoring SOPs, supporting departmental training/competency assessment activities, participating in audits, and serving as a department liaison, as required.

Provides input on KPIs for the Validations section for Biomedical Operations Department.

Maintain a positive work attitude and participate in self-improvement as an effective leader.

Participate in continuing education and attend meetings as required.

Maintain a close working relationship with all other support departments.

Establish operating parameters and quality control limits as required.

Manage and maintain requirements documentation throughout the development of the validation process. Create and maintain requirements traceability matrix (RTM).

Create final validation with linkage to the RTM.

Prepare and maintain reports/records and perform computer data entry.

Performs other duties as assigned.

Non-Essential Tasks

Assist in other areas as directed.

Education

Requires a Bachelor’s Degree from an accredited four-year college or university. The required major is Applied Science or equivalent.

Licenses and/or Certifications

Must obtain and maintain a Train the Trainer certification

Categorical Certifications preferred

LEAN and/or Six Sigma Certification preferred

Experience

Requires three or more years of job specific experience, to include the following experience as follows. Requires two or more years of laboratory experience.

Requires two or more years of experience of working with vendors such as lab service providers, preventative maintenance service providers, and IQ/OQ/PQ service providers, including internal and external partners. Requires one or more years of validation writing experience.

Requires one or more years of validation facilitating and processing experience to include preparing the validation documentation in accordance with SOPs and Quality enforced guidelines and as well as have experience working with internal/external partners on the validation IQ/OQ/PQ processes.

Requires experience drafting workflows/process flows.

Requires experience with Quality Systems and documentation management and revisions. Must be familiar with the equipment maintenance system, environmental monitoring system, and ticket management systems. Must be familiar with pulling reports from the equipment maintenance system and environmental monitoring system to support validation activities/audit requests.

Requires experience working in a regulated environment.

Requires experience in the following areas: Technical writing, validation documentation drafting, assay validation, equipment validation, procedural validation; as well as training, and updating of SOPs, WI’s, job aides and other instructional forms.

Requires experience with successfully completing validations and/or verifications from start to finish.

Knowledge

Must maintain familiarity of regulatory/quality compliance, to include FDA, EU, ISO, GHM, cGMP, OSHA, etc. Must have a working knowledge of lean methodologies.

Must have technical writing knowledge in a pharmaceutical, hospital, clinical, laboratory testing, and cGMP spaces. Must have knowledge with Good Documenting Practices, cGMP, Master Control or similar programs. Must have knowledge of working with, and on audit compliant software.

Must maintain knowledge of and perform according to Standard Operating Procedures (SOPs) and policies. Must have a working knowledge of laboratory sciences, techniques, and equipment.

Must be able to demonstrate a bias for documentation and accuracy.

Must work with a strong “right first time” mentality and drive for results.

Must be able to source documentation as needed for effective and accurate completion of compliance-related initiatives, document creation, updates, and validations.

Must have a working knowledge of process validations, facility qualification, utility qualification and IQ, OQ, PQ for equipment.

Skills

Must have outstanding time management skills.

Must have excellent written and oral communication skills.

Must be capable of evaluating, interpreting, and reporting accurate/valid test results by current testing methodologies.

Must be familiar with laboratory skills for liquid and material handling.

Must have strong computer skills (Word, Excel, PowerPoint, etc.).

Must be tactful in communications and be able to present and share knowledge constructively.

Must be organized and results oriented.

Must be able to manage multiple priorities simultaneously.

Must have experience utilizing equipment management systems.

Must have excellent interpersonal and public speaking skills.

Must have excellent communication and documentation (GDP) skills.

Must have great analytical skills and be able to identify and solve issues that arise during the validation process. Must possess data analysis and interpretation skills to effectively evaluate validation results.

Must be adept at troubleshooting issues that arise with validations, project coordination, and other job duties assigned.

Abilities

Must be a problem-solver and able to develop effective relationships with internal partners such as enterprise Quality and Compliance Departments to ensure that validations go smoothly. Being able to build positive relationships with internal/external partners is necessary.

Must be a self-starter and self-directed worker.

Must be able to adapt to changes in customer and regulatory requirements as well as the evolving system or service features and functionalities.

Must be able to develop high-level timelines for deliverables.

Must be able to keep information confidential.

Must be able to maintain timelines for each validation and deliver each on time within scope.

Must be able to manage multiple priorities simultaneously.

Must be able to seek feedback and utilize it for continuous process and performance improvement. Being adaptable and open to recommendations on project work direction and completion, as well as receiving constructive criticism from peers and managers.

Must be able to take the initiative and be persistent in obtaining Departmental requirements regarding validation/verification requests.

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 adept at troubleshooting issues that arise with validations, project coordination, and other job duties assigned.

Must be neat in appearance and well groomed.

Must be professional, detail oriented, self-motivated, innovative, creative, assertive, organized, communicative, and be able to work independently.

Must have a passion for ensuring that systems, services, and processes meet predefined standards and specifications.

Must have excellent interpersonal and public speaking skills.

Must have experience utilizing equipment management systems.

Must have great analytical skills and be able to identify and solve issues that arise during the validation process. Must have the ability to train others to a competent level.

Must perform well in repetitive work situations.

Must possess data analysis and interpretation skills to effectively evaluate validation results.

Working Environment

Works 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 I

Physical Requirements

Will sit, stand, walk, and bend during working hours.

Requires manual and finger dexterity and eye-hand coordination.

Required to carry up to 25 lbs. and occasionally lift up to 40 lbs.

Requires normal or corrected vision and hearing corrected to a normal range.

Must be able to travel to remote sites 10-25%.

Judgment and Decision Making

Performs duties within scope of general policies, procedures, and objectives. Analyzes problems and performs needs assessments. Completes research tasks independently and judges quality of results. Analysis involves breaking down the problem into parts, examining the parts, and reaching conclusions that result in processes. Applies known and established theory, principle, conceptual models, professional standards, and precedents in order to determine their relationship to the problem. Uses independent judgment in adapting broad guidelines to achieve desired result. Regular exercise of independent judgment within accepted practices. Makes recommendations that affect policies, procedures, and practices. May refer some exceptions to policy and procedures to the supervisor. Dependent upon other factors, this level generally applies to exempt jobs under the FLSA.

We 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 Vision

BioBridge Global and its subsidiaries are proud to be an Equal Opportunity Employer committed to providing employment opportunities. All qualified applicants will receive consideration for employment without regard to race, color, sex, sexual orientation, gender identity, religion, national origin, disability, veteran status, or other legally protected status. For more information about your EEO rights as an applicant under the law, please click here . BioBridge Global maintains a Tobacco & Drug-Free Workplace.