Product Compliance Specialist Job at BioBridge Global
Our organization is unique in that we are a nonprofit community resource that saves lives by working with volunteer donors to provide the highest quality blood & tissue components to patients. By using cutting-edge technology, our team of dedicated professionals has helped save hundreds of thousands of lives for more than 35 years. Over 200,000 components of life-saving blood and tissue from volunteers throughout South Texas are collected and tested each year. We are internationally recognized for the quality of our services and research. Donors are essential because patients are in constant need of blood, blood components, and/or tissue. It's about life! Share our excitement and 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.
Job Title: Product Compliance Specialist
Revision: 0000
Job Code: 703730
Shift: Monday-Friday, 8am-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 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
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
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 click here. BioBridge Global maintains a Tobacco & Drug-Free Workplace
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