Quality Assurance Specialist

FARMAKEIO Pharmacy Network • Southlake, TX

13d

About The Position

The Quality Assurance Specialist will support day-to-day Quality activities within our GMP- regulated 503B outsourcing facility. This role will be involved in a variety of Quality systems, including deviation investigations, complaint handling, change control, CAPA support, document control, batch record review, and general quality systems support.

Requirements

• The ideal candidate will bring prior experience in a GMP-regulated environment, strong attention to detail, and a practical, collaborative approach to Quality.
• This role is intended to grow along with the company.
• The successful candidate will gain broad exposure to core Quality systems and responsibilities, with the opportunity to develop into a Quality Supervisor and potentially a Quality Manager-level role over time based on performance, business needs, and organizational growth.

Nice To Haves

• Bachelor’s degree in a scientific discipline or related field preferred
• Minimum of 2–5 years of experience in a GMP-regulated environment
• Experience in pharmaceutical manufacturing, compounding, sterile or aseptic processing, or another FDA-regulated industry preferred
• Working knowledge of GMP documentation practices and quality systems
• Experience supporting one or more of the following: deviations, investigations, complaints, CAPA, change control, document control, or batch record review
• Strong written and verbal communication skills
• Strong attention to detail, organization, and follow-through
• Ability to manage multiple priorities in a growing company environment
• Ability to work independently while collaborating effectively across departments
• Proficiency in Microsoft Office and comfort learning electronic quality systems or document management tools
• Experience in a 503B outsourcing facility or compounding environment
• Experience supporting inspection readiness or internal audit activities
• Experience reviewing or revising SOPs, forms, logbooks, and controlled records
• Experience in a small or growing manufacturing company where flexibility and cross-functional support are important
• Familiarity with root cause investigation tools and quality risk-based decision making
• Strong investigation and problem-solving mindset
• Clear, concise, and accurate documentation skills
• Good judgment and a practical approach to compliance
• Ability to communicate effectively across functions
• Ownership, accountability, and follow-through
• Willingness to learn, grow, and take on increasing responsibility over time

Responsibilities

• Support daily Quality Assurance activities in a GMP-regulated 503B outsourcing facility
• Participate in investigations related to deviations, nonconformances, complaints, and other quality events
• Assist with complaint intake, documentation, follow-up, and closure
• Support change control activities, including impact assessments, implementation tracking, and closure
• Assist with CAPA initiation, tracking, follow-up, and effectiveness checks
• Review GMP documentation for completeness, accuracy, and compliance with internal procedures and regulatory expectations
• Support document control activities, including creation, revision, issuance, reconciliation, archival, and periodic review of controlled documents
• Assist with batch record review and related documentation review, as assigned
• Maintain quality system logs, records, and tracking tools
• Partner with Production, Quality Control, and other departments to support compliant operations and timely resolution of quality issues
• Support internal audits, inspection readiness efforts, and continuous improvement initiatives
• Escalate quality and compliance risks in a timely and appropriate manner
• Perform other Quality-related duties as assigned to support company growth

Benefits

• 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.

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level