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Quality Specialist 1 1

Company BioBridge Global
Location San Antonio, TX 78201
Update 8 Day ago
300
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!
QualTex Laboratories, a subsidiary of BioBridge Global, is one of the largest independent non-profit testing laboratories in the United States for blood and plasma products. QualTex Laboratories is dedicated to supporting global public safety with the timely delivery of high-quality testing services for patients, donors and regulated biological products.

Job Title: Quality Control Specialist, QualTex

Shift: Friday-Sunday, 2pm to 10:30pm (Part Time)

FLSA: OT Eligible

Location: San Antonio

Dept.: Quality Control HQ

Business Unit: QualTex-SA

General Summary

Responsible to perform specialized duties and activities assigned by the department. Recognize unusual results/outcomes that do not adhere to procedural or quality standards. Provide advanced troubleshooting to resolve discrepancies. Maintain high level of knowledge in cGMPs, regulatory, and quality requirements. Follow all Standard Operating Procedures (SOPs) required to perform effectively. Maintain effective communication with internal and external customers.

Commit to and abide by the character of BioBridge Global’s Core Values of Accountability, Stewardship, Pioneer, Integrity, Respect and Excellence (ASPIRE).

Provide world class customer service by capturing and being responsive to the voice of the customer (including donors) through established 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

Competently perform all assigned departmental duties. May include auditing, lot release, statistical analysis, and use of quality improvement tools.

Evaluate results/reports in an accurate and timely manner; recognize and resolve unusual and/or highly complex problems.

Assist in developing, planning, and conducting process enhancements.

Recognize process deviations or problems and use independent judgment and/or experience to resolve.

Prepare and maintain correspondence, reports, and records as needed. Assist with the document control system.

Maintain strict adherence to Standard Operating Procedures (SOPs). Perform computer data entry.

Commit to and embrace the mission, vision, and core values of QualTex Laboratories:

Positive work attitude
Respect for co-workers and management staff
Excellent customer service [for both internal and external customers]
Adherence to all safety, regulatory, and quality requirements
Continuous improvement
Participate in continuing education and attend meetings as required.

Assist with training and/or mentoring of new employees and/or volunteers.

Participate in team oriented work projects for the development and implementation of validations, process improvements, and Standard Operating Procedures (SOPs).

Performs other duties as assigned.

Non-Essential Tasks

Assist in other laboratory areas as directed.

Education

Requires an Associate Degree from an accredited college or university in a specialized area. Required major is Applied Sciences or equivalent.

Prefer a Bachelor’s Degree from an accredited college or university OR five years related experience equivalent to a Bachelor’s Degree.

Licenses and/or Certifications

Categorical Certifications preferred

Certified Medical Laboratory Technician (MLT) or equivalent preferred

Quality certification preferred

Experience

Requires two or more years of laboratory or quality work environment experience.

Knowledge

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).

Skills

Must have the skills to recognize unusual results and troubleshoot testing problems as soon as detected. Must be capable of performing, evaluating, and reporting on quality review.

Must have strong computer skills.

Must have excellent written and oral communication skills.

Abilities

Must be able to keep information confidential.

Must be able to work with interruptions, meet deadlines, and perform accurate work and/or reports.

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.

Must work well independently and as a team member.

Working Environment

Works in a well-lighted air conditioned and heated laboratory/department. May require work with laboratory and robotic instrumentation. 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 to include being on-call.

Physical Requirements

Requires manual and finger dexterity and eye-hand coordination.

Will require walking, bending, and prolonged sitting and/or standing during work hours.

Required to carry up to 25 lbs. and occasionally lift up to 40 lbs.

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
  • Variable Compensation Plan
  • 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 w/prescription coverage
  • Paid Holidays
  • Variety of Voluntary Supplemental Insurances
  • Leaves of Absence
  • Voluntary Dental Coverage
  • Educational Assistance Program
  • Voluntary Vision
  • Professional Development Plan (PDP)
  • 100% Employer Paid Pension Plan
QualTex Laboratories, 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. QualTex Laboratories maintains a Tobacco & Drug-Free Workplace.