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Job Description

Req#: 28457

QualTex Laboratories is an FDA-registered and CLIA-certified organization that provides state-of-the-art, high volume capacity donor screening and biological testing services. It is one of the largest independent, nonprofit testing laboratories in the United States and has locations in San Antonio and Atlanta

Job Title: Compliance Specialist, Laboratory Services

Revision: 0000

Job Code: 701639

Shift: Day shift, 9:00 a.m. – 5:30 p.m. Hours are flexible

FLSA: OT Eligible

Hybrid? N

Dept.: Lab Services

Business Unit: QualTex ‐ GA

CPF Level: P2

General Summary

Maintain knowledge of all current Standard Operating Procedures (SOPs) and records required to perform effectively. Work with laboratory management to support operations by evaluating current processes and workflows. Responsible for ensuring consistency in practices and procedures as outlined by the SOPs. Maintain excellent communication with the Department and other Laboratory Services personnel regarding daily production and unexpected events to ensure proper actions are being taken.

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.

Major Duties and Responsibilities

Essential Tasks

Complete technical training of pre ‐ analytics and all testing platforms. Assess current processes and procedures.

Develop system for routine observations.

Conduct performance observations on all shifts, as needed.

Assist with the development of workflow consistency and standardization of practices. Assist with investigations for deviations.

Assist with tracking and trending.

Assist with the implementation and oversight of current and, or new processes and provide accurate feedback to Compliance Manager.

Assist with the development of CAPAs and monitoring effectiveness. Conduct retraining as assigned by the Compliance Manager.

Participate in meetings with QA/QC teams. Perform 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

Run departmental errands as directed.

Education

Requires a Bachelor’s Degree from an accredited four ‐ year college or university.

Licenses and/or Certifications

Medical Technician or Certified Laboratory Assistant preferred

Experience

No prior specific work experience required.

Prefer one year of quality and compliance experience. Prefer one year of laboratory experience.

Knowledge

Must obtain a working knowledge of regulatory/quality requirements and perform within all Standard Operating Procedures (SOPs) and policies.

Must acquire a working knowledge of department procedures.

Skills

Must maintain competency in laboratory skills for liquid and material handling. Must be capable of operating laboratory and/or other job related equipment. Must have strong computer skills.

Must be able to print and write legibly.

Abilities

Must be able to keep information confidential.

Must be able to work with interruptions and perform repetitive tasks. 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 be willing to works nights and weekends as needed.

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

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
• 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

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.