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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.

Job Title: Quality Systems Management Specialist

Revision: 0000

Job Code: 703743

Shift: Monday-Friday, Day Shift

FLSA: Exempt

Hybrid? Y

Dept.: Global Quality & Compliance (BBG)

Business Unit: BioBridge Global

CPF Level: TB2

General Summary

Responsible for the execution of tasks associated with the Quality Management Systems (QMS). Quality Systems Management (QSM) functions include but are not limited to performing assessment of compliance to procedures through document (Record) and procedure review, audits and walkthroughs. Performing investigation of deviations or other quality events related to GxP systems, to ensure appropriate root cause analysis is performed and risk appropriate corrective actions and preventive actions are identified. QSM activities also include performing audits and inspections and ensuring inspection readiness at all times. Assessing requests for change and performing Management of Change (MOC) activities including tracking change deliverables and ensuring completion prior to Change Closure. Ensuring equipment maintenance and calibration records are accurate and complete, and that corresponding qualification activities are reviewed for accuracy and completeness. 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.

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 Responsibilities

Essential Tasks

Reviews documentation, including records, procedures, and forms to ensure quality endpoints and compliance requirements are achieved.

Serves as a resource to facilitate Quality Event and CAPA Investigations, Continuous Improvement projects, data analysis, trend identification root cause analysis and development of action plans to support the QMS.

Takes a leading role in the development, implementation and maintenance of Quality System processes required compliance to applicable Standards and Regulations.

Work collaboratively with functional areas to train, guide, and/or facilitate QMS requirements, Continuous Improvement, and Audit Support.

Actively lead and/or contribute to data relevant to Quality Systems Compliance in periodic Management Review meetings.

Assists Quality Management in coordinating and actively participating in Quality or Compliance related projects.

Performs other duties as assigned.

Non‐Essential Tasks

Assist other departments as assigned.

Education

Requires a high school diploma or general equivalency diploma.

Prefer sixty (60) hours from an accredited college or university or Associate Degree from an accredited college or university.

Experience

Requires one or more years of Quality Assurance or Quality Control experience in regulated environment. Prefer two or more years of Quality Assurance or Quality Control experience in regulated environment.

Knowledge

Must acquire a working knowledge of all administrative aspects of document control operations and eQMS.

Must obtain a working knowledge of regulatory/quality requirements and perform within all Standard Operating Procedures (SOPs) and policies.

Must have a working knowledge and understanding of FDA regulations and current Good Manufacturing Practices (cGMPs).

Must maintain knowledge of ISO Standards, cGMP (current Good Manufacturing Practices) and regulatory requirements concerning creation and maintenance of controlled documents and record retention.

Skills

Must have strong computer skills.

Must have experience using Microsoft Office applications including Word, Outlook, Visio, PowerPoint and Excel.

Must have excellent telephone and/or email etiquette skills.

Must have excellent written and oral communication skills.

Abilities

Must be able to keep information confidential. 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 answer telephones and greet the public in a friendly and courteous manner.

Must maintain good working rapport with all departments.

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 ability to reach, lift and carry up to 40 lbs.

Requires manual and finger dexterity and eye‐hand coordination.

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

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 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/eeoc_self_print_poster.pdf) . BioBridge Global maintains a Tobacco & Drug-Free Workplace