Compliance Pharmacist

Summary

Join Mixlab, a rapidly growing veterinary compounding pharmacy, as their Compliance Pharmacist. This full-time role ensures compliance with all federal, state, and industry regulations. Responsibilities include developing and implementing compliance programs, maintaining pharmacy licensing, conducting audits and inspections, and providing compliance training. The ideal candidate possesses 5+ years of pharmacist experience, 3+ years in compliance, and in-depth knowledge of relevant regulations. Located near one of Mixlab's pharmacies (Hollywood, FL; Los Angeles, CA; Milwaukee, WI; New York, NY; Weatherford, TX), travel is required. Mixlab offers a comprehensive benefits package including health insurance, paid time off, and various other perks.

Requirements

• You have experience working as a Pharmacist for 5+ years
• You have 3+ years of experience working in compliance
• You are a licensed Pharmacist in CA or NY and in good standing with all State Boards of Pharmacy
• You have in-depth knowledge of USP <795>, <797>, <800>, FDA GFI #256, and veterinary compounding regulations
• You have experience with pharmacy licensing, DSCSA compliance, and accreditation processes (e.g., NABP VPP)
• Excellent attention to detail, problem-solving skills, and ability to work independently
• Strong communication and training abilities to educate staff on compliance-related matters
• Your attention to detail is impeccable, and you have incredibly high standards for accuracy and quality
• You are collaborative and have a desire to work in a team-oriented, fast-paced startup environment

Responsibilities

• Ensure compliance with federal and state regulations, including FDA, DEA, NABP, USP <795>, <797>, and <800>, and state boards of pharmacy
• Maintain and oversee pharmacy and pharmacist licensing, as well as state-specific non-resident licenses
• Keep up to date with changing regulations and implement necessary policy and procedural updates
• Prepare and lead pharmacy inspections, audits, and regulatory reviews
• Ensure compliance with FDA GFI #256 and oversee policies related to veterinary compounding restrictions and guidance
• Act as the primary liaison with regulatory agencies, responding to inquiries, facilitating inspections, and addressing compliance concerns
• Maintain DSCSA compliance, including track-and-trace requirements for compounded products
• Develop and oversee Standard Operating Procedures (SOPs) to ensure best practices in compounding, dispensing, and quality assurance
• Conduct internal audits and performance improvement initiatives to enhance quality and compliance
• Monitor and enforce adherence to USP standards, including beyond-use dating and environmental monitoring
• Participate in root cause analysis and corrective/preventive action plans (CAPAs) in response to deviations or nonconformities
• Implement and maintain a quality management system (QMS) to track compliance activities and risk mitigation strategies
• Prepare the Annual PI Report
• Report ADRS, internal quality concerns, etc. to applicable agency
• Conduct CQI activities in conjunction with the VP of and OPS and Compliance
• Provide ongoing compliance training to pharmacy personnel, including technicians and pharmacists
• Develop educational materials and conduct training sessions on regulatory updates, best practices, and compliance requirements
• Serve as a resource for pharmacy staff on regulatory and quality-related inquiries
• Investigate and report adverse drug events (ADEs), product complaints, and medication errors as required
• Maintain detailed records of compliance activities, training, audits, and inspections
• Ensure proper documentation of compounding procedures, ingredient traceability, and lot/batch records
• Collaborate with the development team to provide guidance on product features, occasionally participating in sales activities such as calling or visiting veterinary clinics
• Work collaboratively across operational teams including sales, operations, logistics, care, and supply chain
• Process, compound, and review medication orders as needed
• Travel required to Mixlab sites as needed
• Take on any other assignments as directed by the VP of Operations and Compliance

Preferred Qualifications

Additional licenses preferred

Benefits

• 100% employer-paid health, dental and vision insurance for our employees, effective on the first of the month following your start date
• Paid time off for vacation, holidays and sick time, with the ability to accrue more vacation time with increased tenure
• Competitive starting wages with the opportunity for rapid career growth, promotion, and wage increases
• Company Stock Options
• Pre-tax commuter benefits, dependent care, HSA and FSA
• Employer-paid short and long-term disability leave, parental leave, and life insurance
• 401k with $300/year match
• Referral bonus payouts of up to $1,000 for a successful referral
• Human and pet wellness benefits, including $650/year allowance for routine pet care through Wagmo
• Discounts on many items through Perkspot