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Voshell's Pharmacy

Compliance Officer 503A Compounding

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Job Description

Compliance Officer 503A Compounding Voshell's Pharmacy - 3.5 Baltimore, MD Job Details Full-time $95,000 - $130,000 a year 1 day ago Benefits Health insurance 401(k) Paid time off Qualifications Regulatory inspections Procedural guides Formulation chemistry Manufacturing standard operating procedures Laboratory regulatory affairs Team training Standard operating procedures (SOPs) Compounding medications Drug formulation Full Job Description Voshell's Pharmacy | Baltimore, MD (onsite) | Full-time, W-2
Pay:
$95,000 to $130,000 per year, based on licensure and experience. Licensed pharmacists will be placed toward the top of the range.
Benefits:
health insurance, paid time off, 401(k), continuing education support Why this role exists Voshell's is a Baltimore compounding pharmacy that has served patients for nearly a century. We are licensed in five states and building toward all fifty. Every new state license, every new formula, and every new prescriber relationship adds regulatory responsibility. We are looking for one person to own that responsibility end to end, so our pharmacists can focus on compounding and our leadership can grow with confidence that we are always inspection-ready. This role is about building, not just maintaining. You will design the compliance system for a pharmacy that is growing quickly, and your voice will carry real weight when something needs more work before it launches. What you will own Regulatory readiness. Keep us inspection-ready every day for the Maryland Board of Pharmacy, every non-resident board we hold a license with, FDA, and DEA. Run quarterly mock inspections and lead the follow-up. USP standards. Own our program for USP (non-sterile), USP (hazardous drugs), and USP where applicable: SOP control, beyond-use dating, environmental and cleaning records, and personnel training and competency files. 503A guardrails. Oversee patient-specific prescription requirements, office-use rules by state, and FDA limits on compounding drugs that are essentially copies of commercially available products. Review new formulas and programs (GLP-1, BHRT, peptides) for regulatory risk before launch. Multistate licensing. Partner with leadership on our 50-state licensing growth: applications, renewals, change notifications, non-resident inspection requirements, and a live license calendar. Quality events. Own complaints, adverse events (including MedWatch reporting), errors, out-of-specification results, recalls, and corrective actions, with a clear root cause and follow-through for each. Controlled substances and privacy. DEA recordkeeping, inventories, and CSOS oversight for Schedule III products. Ownership of our HIPAA program. Marketing and prescriber review. Review patient-facing and prescriber-facing materials for compliant claims before they go out. Accreditation. Lead our path to NABP accreditation. Formula development. Develop new compounded formulas and improve existing ones: ingredient and excipient selection, compatibility and stability research, beyond-use date assignment, and master formulation records written to USP standards. Every new formula you develop is reviewed and approved by our pharmacist-in-charge before it goes into production. What you bring Required 3+ years in pharmacy compliance, quality assurance, or regulatory affairs, including experience in compounding (503A or 503B), sterile or non-sterile Working knowledge of USP and , and FDCA section 503A Experience supporting a board of pharmacy or FDA inspection and leading the response Ability to write clear SOPs and deliver training that sticks Hands-on compounding formulation experience, including writing master formulation records and assigning beyond-use dates Preferred Active pharmacist license (PharmD or BS Pharm), eligible for Maryland licensure Multistate non-resident licensing experience
NABP/PCAB/ACHC
accreditation experience DEA registrant compliance experience Our core values These are the values we hire for, grow with, and hold each other to. Own It End to End. We take pride in seeing things through. When you pick something up, you carry it all the way to the finish, and we celebrate the results you create. Say It to the Room. Every voice matters here. We share ideas and concerns openly and respectfully, make a decision together, and then support it as one team. Better Than Yesterday. We are always learning. Each day is a chance to grow a little more, and we support each other as the standard rises. Strengthen the Chain. Every role matters, and we succeed together. The best teammates help the people around them grow. The Patient Is the Point. Everything we do comes back to the people we serve and the care they deserve. Integrity above all. Honesty about our work is the foundation everything else rests on. We ask that every record be accurate and every mistake be raised right away, because that is how we keep patients safe and how we earn each other's trust. How to apply Apply through this posting with your resume and a short note answering: Tell us about a compliance issue you caught before an inspector did. What was it, and what did you change? Finalists complete a short work sample (about 90 minutes): a mock-inspection review of a fictional SOP and batch record, plus a review of a fictional master formulation record. Voshell's Pharmacy is an equal opportunity employer.

Benefits

  • Paid Time Off (PTO)
  • 401(k) Plans
  • Professional Development
  • Health Insurance