Overview
Quality Inspector-QA/QC Technician-Precision Sheet Metal Mfg. Jobs in Garland, TX at Irving Tool & Mfg.
Quality Assurance Specialist
Company Overview
At Akina Pharmacy, the shared purpose that drives us is to enrich the lives of the people in our care through compounded medications. As a people-first organization, we embrace the Entrepreneurial Operating System (EOS) to ensure our success by prioritizing the recruitment and development of exceptional talent.
Joining Akina means stepping into an environment where clear communication, pragmatic decision-making, and accountability are at the forefront. We are committed to empowering our team members and fostering a culture of growth and support. If you are driven by a passion for making a meaningful impact and seek a vibrant, compassionate workplace, we invite you to discover the opportunities awaiting you at Akina Pharmacy. Together, let’s build a healthier, happier community.
Position Summary
The Quality Assurance (QA) Specialist plays a pivotal role at Akina Pharmacy, supporting our mission to ensure the highest standards of quality and compliance across sterile and non-sterile compounding operations. This position emphasizes proactive quality assurance practices through internal audits, environmental monitoring, process evaluations, and cross-departmental collaboration.
As a QA Specialist, you will be instrumental in identifying and resolving quality-related events (QREs), conducting root cause analyses (RCA), implementing corrective and preventive actions (CAPAs), and maintaining thorough documentation and audit readiness. The role demands a balance of analytical thinking, precision, and initiative, supporting both continuous improvement efforts and day-to-day quality oversight. Your contributions will ensure alignment with USP guidelines, FDA expectations, and internal quality systems.
Success in this role is rooted in Akina’s values—Excellence Always, Go-Getter’s Unite, Compassion For All, and Called To Serve—and will be evident in your commitment to compliance, training, data integrity, and collaboration.
You will love it here if you are motivated by Akina’s Core Identity Values:
Excellence Always
Go-Getter’s Unite
Compassion For All
Called To Serve
You’ll have success here if you value clear processes and get, want, and have capacity to do the following things:
Environmental & Facility Monitoring: Review, trend, and present results from viable and non-viable air sampling, surface sampling, gloved fingertip tests, aseptic process simulations (media-fills), and in-process quality inspections. Monitor physical parameters including pressure differentials, temperature, and humidity. Ensure compliance with USP <797>, <795>, <800>, and internal quality limits through regular review and timely escalation of deviations.
Audit, Documentation & Compliance Support: Conduct internal audits and reviews of cleaning logs, maintenance records, calibration data, and controlled documents (e.g., SOPs, forms). Maintain oversight of document control, training logs, and validation/calibration records. Ensure audit readiness for regulatory and third-party inspections. Track trends, generate quality reports, and present data-driven insights to leadership.
CAPA, Deviation & Root Cause Analysis (RCA) Management: Lead or support investigations into Quality-Related Events (QREs), deviations, and customer complaints. Perform structured Root Cause Analysis (e.g., 5 Whys, Fishbone, Fault Tree) to identify systemic issues. Propose, implement, and verify the effectiveness of Corrective and Preventive Actions (CAPAs). Participate in quality risk assessments and update SOPs or training as needed.
Batch Release & Quality Oversight: Participate in the batch release process by reviewing compounding records, laboratory results, packaging documentation, and quarantine status to ensure product quality and regulatory compliance. Conduct Acceptable Quality Limit (AQL) inspections on sterile Category 2 and Category 3 compounded batches to detect visual and functional defects. Verify label reconciliation and packaging integrity prior to batch release.
Process Improvement & Training: Collaborate across departments to support continuous improvement initiatives, SOP revisions, and CAPA-driven changes. Perform training needs assessments and track competency of personnel involved in sterile and non-sterile compounding. Deliver or coordinate training programs to close knowledge gaps, improve compliance, and align performance with updated quality and regulatory expectations.
We train our team to help them succeed, and everyone on our team helps with our success. In this role, you’ll be accountable for hitting the following numbers:
QRE Management: Complete approximately 10 Quality-Related Event (QRE) investigations per week, including documentation, root cause analysis, and implementation of CAPAs.
Environmental Monitoring Review: Review and assess results from approximately 300–400 samples per month, including air, surface, and fingertip sampling data.
AQL Inspections: Conduct sampling and inspections on ~100 sterile product batches/month, accounting for ~1300 vials, using AQL standards.
Batch Release: Review and release approximately 100 batches per month of sterile Category 2 and Category 3 compounded products, ensuring all quality, documentation, and regulatory criteria are met prior to distribution.
Our company runs on EOS purely. That means as a member of this team, you will have a leader who:
Gives clear directions and expectations
Makes sure you have the necessary tools
Delegates appropriately
Has effective meetings
Meets one-on-one with you quarterly or more, if needed
Rewards and recognizes your performance
Experience and Qualifications
Education: Bachelor’s Degree in Biology, Microbiology, Chemistry, Toxicology, Nursing, Clinical Laboratory Science, or a related field.
Expertise: Minimum of 1 year in Quality Assurance or Control, with experience in audits, compliance, or analytical troubleshooting.. Experience in clinical, industrial, or laboratory environments involving investigative or problem-solving responsibilities is strongly preferred.
Regulatory Familiarity: Working knowledge of cGMP, USP <797>, <795>, and <800>. Experience in pharmaceutical compounding operations or regulated environments is preferred.
Technology Skills: Proficient in digital quality management systems, data tracking tools, and SOP documentation platforms. Comfortable navigating and adapting to evolving technology systems.
Soft Skills:Excellent written and verbal communication skills. Strong organizational ability, attention to detail, and critical thinking. Demonstrates adaptability, a collaborative mindset, and a commitment to continuous learning and quality improvement.
Benefits & Perks
Comprehensive Medical, Dental, and Vision Options: Choose from three medical plans tailored to your needs, plus options for dental and vision coverage for you and your family.
Paid time off (vacation and sick time): Take advantage of generous paid time off to recharge, focus on personal priorities, and maintain a healthy work-life balance.
Paid Holidays (8 scheduled): Enjoy eight scheduled paid holidays to celebrate and spend quality time with loved ones.
401K Dollar-for-Dollar Up to 4%: Invest in your future with our 401K plan, featuring a dollar-for-dollar match up to 4%.
Rewards & Recognition Program: Be celebrated for your hard work and achievements through our dedicated rewards and recognition program.
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Title: Quality Inspector-QA/QC Technician-Precision Sheet Metal Mfg.
Company: Irving Tool & Mfg.
Location: Garland, TX
