PRODUCT COMPLIANCE SPECIALIST - BioBridge Global : Job Details

_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) ( 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.

Pay Rate: Hourly: $23.40-$27.00/ Annually $48,672.00-$56,160.00

Job Title: Product Compliance Specialist

Revision: 0000

Job Code: 703730

Shift: Monday-Friday 9am-5pm

FLSA: OT Eligible

Hybrid? N

CPF Level: TB1

Location: San Antonio

Dept.: Global Quality & Compliance (BBG)

Business Unit: BioBridge Global

**General Summary**

Responsible for completing assigned product compliance processes and activities.

This position is responsible for requesting and aggregating records associated with product compliance processes, including serological positive donors and external agencies.

This position is responsible for routing materials appropriately and creating final charts for further review.

Requires organizational and time?management skills, verbal and written communication skills, as well as attention to detail.

Commit to and abide by the character of BioBridge Globals 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

Review documentation, including records, procedures, and forms to ensure quality endpoints and compliance requirements.

Create donor packets and letters for serological positive donors, and perform investigations associated with viral positive donors.

Coordinate and facilitate relevant meetings.

Request documents necessary to complete cadaveric, cord blood, and birth tissue charts.

Receive serology and culture results and route to appropriate drives and/or batch records.

Support process improvements efforts.

Suggest improvements to address and potential process issues and/or to ensure consistency. Performs other duties as assigned.

Non?Essential Tasks

Assist with other department duties as needed.

**Education**

Requires a high school diploma or general equivalency diploma.

**Experience**

No prior specific work experience required.

Prefer one year of Quality & Compliance experience in regulated environment or other job related experience.

**Knowledge**

Must maintain knowledge of and perform according to Standard Operating Procedures (SOPs) and policies.

Must acquire an understanding in document control, product change control, quality systems, and regulatory documentation.

Must maintain familiarity of regulatory/quality compliance, to include FDA, EU, ISO, GHM, cGMP, OSHA, etc.

**Skills**

Must have the skills to recognize unusual results and troubleshoot testing problems as soon as detected.

Must have excellent problem solving and interpersonal skills.

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

Must have strong computer skills.

Must have excellent written and oral communication skills.

**Abilities**

Must be a team player.

Must be able to keep information confidential.

Must be able to perform multiple requests simultaneously while maintaining quality and accuracy.

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 perform well in repetitive work situations.

**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

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 ( . BioBridge Global maintains a Tobacco & Drug-Free Workplace