BioBridge Global Quality Assurance Specialist - GenCure in San Antonio, Texas
GenCure at http://gencure.org/ , a subsidiary of BioBridge Global, applies advances in regenerative medicine to help heal patients suffering from trauma, disease or the aging process. Using processed tissue and cell-based therapies, GenCure works to connect needs with solutions. GenCure is both a direct supplier to healthcare providers and a partner with commercial and non-profit organizations providing regenerative medicine treatments to patients.
DEPARTMENT: Quality Assurance
JOB TITLE: Quality Assurance Specialist
FLSA STATUS: Exempt
GENERAL STATEMENT OF DUTIES: Review validation, calibration, Quality Control (QC), and maintenance records for equipment, supplies, and environmental monitoring records for the GenCure subsidiary of BioBridge Global. Review Standard Operating Procedures (SOPs) and forms. Assist with conducting internal audits and during external audits. Provide assistance to departments for special projects.
Education: Bachelor's Degree in Laboratory Science or related discipline
Experience: Two years experience in an FDA regulated environment
Blood Center or Tissue Bank experience preferred
Must have working knowledge of PC software applications using Windows, Microsoft Word, Excel and other software programs as required
Certification/License: MLS (ASCP) / MT (ASCP) or CTBS preferred
Knowledge: Must have working knowledge of regulations and standards for biologics, including but not limited to blood products and HCTPs. Must acquire a working knowledge of donor suitability criteria and infectious disease testing. Must maintain knowledge of and perform according to Standard Operating Procedures (SOPs) and policies. Must maintain a knowledge of cGMP (current Good Manufacturing Practices), cGTP (current Good Tissue Practices), and CLIA regulations. Must maintain knowledge of applicable industry standards, including but not limited to ISO, AABB and AATB.
Skills: Must have excellent oral and written communication skills. Computer skills required.
Abilities: Must be professional, detail oriented, self motivated, innovative, creative, assertive, organized, communicative, and have the ability to work independently. Must be a self-starter and self-directed worker. Must maintain good working rapport with all departments. Must be able to keep information confidential. Must be neat in appearance and well groomed.
Commit to and abide by the character of BioBridge Global’s Core Values of Respect, Integrity, and Excellence (RIE).
Review new or revised Standard Operating Procedures (SOPs) and forms for compliance with applicable regulations.
Assist departments in the development, revision, and preparation of SOPs and forms in accordance with policies, regulations and protocols.
Advise departments in the establishment of calibration protocols and maintenance records in accordance with cGMP, cGTP and/or regulatory requirements.
Assist with coordination of proficiency testing.
Advise departments and assist with development of validation plans.
Review of validation plans, data and summaries.
Perform validations as required.
Assist in the review and management of equipment, calibration, and maintenance records.
Perform batch release review.
Review HCT/P component QC for compliance to standards and regulations.
Assist in conducting internal and external audits.
Assist in maintenance of Quality Assurance (QA) databases.
Assist business units with analyzing metrics for trends.
Review cord blood, PBSC and tissue donation records.
Maintain a positive working relationship with management, co-workers, donors and the public.
May perform other tasks as assigned.
- Know the responsibilities of co-workers and perform those activities in the event of their absence.
TYPICAL PHYSICAL DEMANDS: Will sit, stand, walk and bend during working hours. Required to lift and carry relatively light materials. Requires manual and finger dexterity and eye-hand coordination. Requires normal or corrected vision and hearing within a normal range.
TYPICAL WORKING CONDITIONS: Works in well lighted, air conditioned and heated office. May be exposed to electrical and chemical hazards and other conditions common to an office environment. May be required to work at any time of the day, evening or night during the week or weekend.
• Paid Time Off (PTO)
• 100% Employer Paid Employee Assistance Program
• Extended Illness Benefits (EIB)
• Group Health Medical Plan w/prescription coverage
• Shift Differentials
• Variety of Voluntary Supplemental Insurances
• Paid Holidays
• Voluntary Dental Coverage
• Leaves of Absence
• Voluntary Vision
• Educational Assistance Program
• Flexible Benefit Cafeteria Plan
• Credit Union
• Tax Deferred Retirement Plan
• 100% Employer Paid Pension Plan
• 100% Employer Paid Life Insurance
GenCure, a subsidiary of BioBridge Global, is 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 at http://www1.eeoc.gov/employers/upload/eeocselfprint_poster.pdf . GenCure maintains a Tobacco & Drug-Free Workplace.