"Alerted.org

_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: Senior Quality Control Specialist

Revision: 0002

Job Code: 703753

Shift:

FLSA: OT Eligible

Hybrid? Y

Dept.: Global Quality & Compliance (BBG)

Business Unit: BioBridge Global

CPF Level: TB3

General Summary

Responsible for completing assigned Quality Control QC processes, programs and to conduct QC activities.

This position is responsible for ensuring compliance in all stages of product or sample testing and review; as well as performing QC testing on in-process, product, stability and/or research samples and other operational activities.

This position will identify continuous process improvement areas, in compliance with GMP processes and documentation for quality control activities.

Requires excellent technical skills and abilities, analytical and mathematical skills, organizational and time-management skills, verbal and written communication skills, as well as the ability to apply attention to detail.

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

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

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.

Conduct Product Tests and Assessment in an industrial or warehouse setting to ensure that specifications are met, and that the product, material, or supply will function as intended.

Perform in-process and final product/result inspections and clearances on the production floor to ensure consistency.

Identify product defects or potential issues and determining what to do to resolve the issue.

Analyze the results of lab or usability tests to identify these defects and make sure they do not persist.

Maintain detailed records of product defects or manufacturing issues as they test and assess products to help identify and eliminate recurring problems and also provide a paper trail to aid in accountability and errorreporting.

Notify of issues or defect reports to supervisors or plant managers to help them make decisions about manufacturing processes and practices.

Support process improvements throughout the testing and quality assurance processes.

Suggest improvements to address potential systemic problems found during quality control, to ensure that products are produced consistently, and that defects or other errors will not persist throughout the manufacturing or testing process.

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.

Licenses and/or Certifications

Valid United States Driver’s License

Experience

Requires three or more years of Quality Assurance or Quality Control experience in regulated environment or other job related experience.

If Associate's Degree is attained, requires two or more years of Quality related experience.

Knowledge

Must have a working knowledge of various LIS software programs.

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

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

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

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.

Must be capable of operating motor vehicles in all types of weather conditions.

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

Must be able to drive on behalf of the organization.

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. 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.