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Quality Specialist 1 1Company BioBridge Global
Location San Antonio, TX 78201
Update 8 Day ago
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
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
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
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.
Assist in other laboratory areas as directed.
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
Requires two or more years of laboratory or quality work environment experience.
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).
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.
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.
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.
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