Quality Specialist I

Creative Testing Solutions•San Marcos, TX

About The Position

Under general supervision, the Quality Specialist I applies standard procedures and quality methodologies to ensure that test results and cGMP laboratory testing processes meet requirements for final approval and release to laboratory customers. The role reviews routine biological sample testing and verifies that test-batch source data meets quality attributes and cGMP requirements before results are reported. It also approves final test results for release. The position maintains accurate records and documentation in accordance with established procedures and good documentation practices, protects donor, patient, and employee confidentiality, supports archival record organization, and ensures SOPs are followed. The Quality Specialist works with personnel across departments, resolves routine issues using SOPs, escalates matters as appropriate, analyzes environmental monitoring, and assists with investigations and environmental issue resolution. Depending on assignment, the role may review equipment re-qualifications, equipment calibrations and verifications, and critical testing reagents; assist with reagent lot changes; or pack and ship supplies or specimens. The role participates in performance improvement and training programs, provides quality customer service, complies with internal SOPs and external regulations, and brings compliance issues to management’s attention. The schedule is Tuesday through Saturday, 6:00 a.m. to 2:30 p.m. Travel is less than 5%. The laboratory environment includes exposure to biological fluids and potential infectious organisms, extreme cold, production chemicals, moving machinery and equipment, and high noise levels. Personal protective equipment is required.

Requirements

Bachelor’s degree required.
Appropriate state licensure and/or certificate required where applicable.
Must possess the skills and abilities needed to perform assigned duties and responsibilities.
Strong critical-thinking and problem-solving skills.
Ability to maintain confidentiality.
Proficient computer skills and knowledge of computer operation in a Windows environment, including following company procedures to resolve issues.
Ability to work in a team environment and participate as an active team member.
Ability to understand, follow, and give precise written and verbal instructions, perform activities safely, and read and comprehend written procedures and instructions.
Ability to meet the physical requirements described for the role, including extended sitting, standing, handling, finger dexterity and pinching; lifting up to 40 pounds; and walking, climbing, bending, squatting, reaching, grasping, and carrying or moving items up to 40 pounds.

Nice To Haves

Bachelor’s degree in biology, chemistry, or another science-related field.
Previous experience with adult training concepts and their applications.
Trainer Certification.

Responsibilities

Review and approve quality control and verifications for routine biological sample testing; review test batches and verify source data meets quality attributes and cGMP requirements before results are reported.
Approve final test results for release to laboratory customers.
Maintain accurate records and documentation in accordance with procedures and good documentation practices, while maintaining donor, patient, and employee confidentiality.
Support archival record organization and classification maintenance, and ensure SOPs are followed.
Partner with personnel from various departments, resolve routine problems by following SOPs, and escalate issues as appropriate.
Analyze environmental monitoring and assist with investigations, including addressing temperature and humidity issues.
May review equipment re-qualifications and release instrumentation back into the production environment.
May review and approve general laboratory equipment calibrations and verifications and confirm acceptance criteria are met.
May review and approve critical testing reagents for production use and assist with lot changes as directed.
May pack and ship supplies and/or specimens.
Participate in performance improvement teams and training programs as required.
Provide quality customer service and perform assigned duties in compliance with internal SOPs and external regulations.
Bring compliance issues to management’s attention.
Maintain attendance and punctuality in accordance with the absence policy.
Perform other duties as assigned by management.