Quality Assurance Specialist

Company / Entity: PharmaSource Direct Job Location: Englewood, CO 80112, United States (Full-Time In-Person) Job Title: Quality Assurance Specialist Reports to: Director of Quality & Regulatory Hours: 8:30 AM - 5:00 PM FLSA Status: Non-Exempt Employment Type: Full-Time (Full-Time In-Person) Choice isn’t optional. It’s everything. Too many companies in the pharmaceutical industry treat quality as automatic. At Pharma Source Direct, we reject that mentality. We exist to give compounding pharmacies and outsourcing facilities a transparent, uncompromising alternative to transactional wholesale. PharmaSource Direct exists to blow that model wide open. Modern medicine is moving beyond one-size-fits-all prescriptions - and Pharma Source Direct is the engine behind that shift. We’re redefining pharmaceutical compounding wholesale by replacing cookie-cutter distribution with high-touch service, specialty API importing, and uncompromising regulatory rigor. Serving 503A pharmacies and 503B facilities nationwide, we deliver the purity, traceability, and customized support that empower providers to treat the individual, not the average. We’re looking for sharp, driven people ready to raise the standard of pharmaceutical supply. Get Well. Live Well. Position Overview PharmaSource Direct is a rapidly expanding leader in the Active Pharmaceutical Ingredient (API) wholesale sector, committed to maintaining the highest standards of safety and compliance. We are seeking a meticulous and proactive Quality Assurance Specialist to join our dedicated team in Englewood, CO. This pivotal role is essential to our operations, serving as the guardian of our quality systems and ensuring that every product we distribute meets rigorous regulatory requirements. Reporting directly to the Director of Quality & Regulatory, you will play a hands-on role in upholding our commitment to excellence. You will function as a bridge between operational departments and regulatory compliance, ensuring that our internal processes are not only robust but also optimized for continuous improvement. If you are an detail-oriented professional who thrives in a collaborative, fast-paced environment where your work directly impacts product integrity and patient safety, we encourage you to apply. What Your Day-to-Day Looks Like Your daily workflow is dynamic, requiring a balance between desk-based documentation and active participation on the production floor. You can expect your time to be allocated as follows: approximately 40% of your time will be dedicated to document control, SOP management, and batch record reviews. Another 30% will involve direct oversight of production activities, investigating nonconformances, and supporting supplier qualification tasks. The remaining 30% will focus on cross-functional collaboration, internal auditing, KPI data reporting, and leading quality training initiatives to ensure every team member is aligned with our standards.

Key Responsibilities

• Conduct comprehensive reviews of batch records, Certificates of Analysis (COA), and other critical compliance documentation.
• Manage the lifecycle of controlled documents, including SOPs, forms, and comprehensive training records.
• Perform consistent on-the-floor Quality Assurance observations within the Operations and Production areas to ensure standard adherence.
• Oversee the lifecycle of nonconformances, deviations, and customer complaints, facilitating timely investigations and driving effective Corrective and Preventive Actions (CAPA).
• Execute supplier qualification processes, including performing audits and maintaining detailed supplier compliance files.
• Coordinate with external laboratory partners for essential API testing requirements.
• Perform internal audits according to the established company schedule and support preparation for customer or regulatory authority inspections.
• Prepare and submit detailed quality reports to comply with all relevant Federal and State requirements.
• Facilitate recurring QA training meetings to foster a culture of quality awareness across the organization.
• Collaborate with cross-functional teams to identify opportunities for process optimization and continuous improvement.

Required Qualifications & Experience

• Bachelor’s degree in Life Sciences, Chemistry, or a closely related scientific field.
• Minimum of 2+ years of professional experience in Quality Assurance or Quality Compliance specifically within the pharmaceutical or API manufacturing industry.
• Demonstrated familiarity with current GMP regulations, FDA guidelines, and modern pharmaceutical quality systems.
• High level of technical proficiency with Microsoft Office Suite, particularly Word and Excel.
• Working knowledge of Quality Management Systems (e.g., MasterControl).
• Exceptional organizational skills with the ability to manage multiple high-priority tasks simultaneously.
• Strong written and verbal communication skills with the ability to perform precise technical writing.
• Must be willing to undergo and pass a comprehensive pre-employment background check and drug screening.

Please note: We kindly ask that candidates only apply if they meet the required qualifications listed above. Preferred Qualifications (Nice to Have)

• Specific experience conducting detailed technical investigations and root cause analysis.
• Previous experience acting as a primary point of contact for external regulatory auditors.
• Advanced certification in Quality Assurance or Regulatory Affairs.
• Proven track record of improving quality SOPs or documentation workflows.

Work Environment & Location Expectations This is a Full-Time, Non-Exempt position based in our Englewood, CO 80112 facility. This role is strictly Full-Time In-Person; remote work is not available for this position. The standard work schedule is Monday through Friday, from 8:00 AM to 5:00 PM. Candidates should be comfortable working in an office and production environment and must be available for standard business hours to ensure full oversight of operational and quality activities. We are committed to supporting our team’s health, financial future, and work-life balance. Our benefits include: Healthcare Coverage: Comprehensive health, dental, and vision insurance plans with company-subsidized premiums. Peace of Mind: 100% company-paid Short-Term Disability (STD), Long-Term Disability (LTD), and Life Insurance. Retirement Savings: A 401(k) plan featuring a 4% company match to help you build for the future. Work-Life Balance: Generous Paid Time Off (PTO) so you can relax, recharge, and take care of what matters most. Our Mission To empower individuals and providers with personalized, root-cause-focused care that restores health, balance, and freedom. Our Vision To lead a transformative shift in modern medicine…where deeper insights, proactive care, and personal choice define the future of wellness. Our Values Care: We provide a welcoming, nurturing environment for our staff and our clients. Growth: We are dedicated to fostering beneficial change for ourselves and those we serve. Respect: We are unwavering in our commitment to speak with honor and listen without judgement. Partnership: Working collaboratively to build trust, value diverse perspectives, and achieve shared goals. Integrity: Acts with honesty, accountability, and alignment to company values.

PharmaSource Direct • 8591 Prairie Trail Dr. Suite C-600 Englewood, CO 80112 • Englewood, CO 80112, United States