Compounding Pharmacist

TITLE: Compounding Pharmacist
TYPE: Direct Hire
LOCATION: Apex, NC
ONSITE/REMOTE/HYBRID: Onsite
START DATE: February/March 2026

At The Vanguard Utility Corporation, we are building a new 503B outsourcing facility focused on patient safety, regulatory compliance, and operational excellence. We are seeking a hands-on Compounding Pharmacist to support daily sterile production and report directly to the Pharmacist-in-Charge.

This role provides pharmacist oversight of Compounded Sterile Preparations (CSPs), verifies critical manufacturing steps, and ensures all pharmacy-controlled activities meet cGMP and regulatory requirements. The Compounding Pharmacist works closely with Production, Quality Assurance, and Quality Control to support compliant operations and continuous improvement.

As part of a startup environment, this position requires flexibility, sound professional judgment, and a willingness to support early-stage buildout activities as systems and workflows evolve.

KEY RESPONSIBILITIES
Compounding Operations and Oversight

• Oversee daily sterile compounding and production activities in compliance with FDA CFRs, cGMP, DEA, and State Board of Pharmacy regulations
• Verify and sign off on critical manufacturing steps per batch records and SOPs
• Monitor gowning, aseptic technique, and cleanroom behavior
• Support batch record review and collaborate with QA on discrepancies
• Maintain controlled substance compliance under the direction of the PIC
• Work closely with Production, QA, and QC to ensure accurate execution and documentation

Quality and Regulatory Support

• Participate in investigations, CAPAs, and change controls related to pharmacy operations
• Review and approve applicable documentation, including batch records, labels, and supporting records
• Assist with writing, reviewing, and updating SOPs and cGMP documentation
• Stay current on FDA guidance and regulatory changes impacting 503B operations
• Support audits, training initiatives, and continuous improvement efforts

Training and Startup Support

• Provide and support aseptic technique and GMP training for compounding personnel
• Assist with workflow setup, documentation improvements, and early-stage operational support
• Support new product development activities, including batch records, labeling, and stability protocols
• Obtain required non-resident pharmacist licenses within one year, as directed
• Perform other duties as assigned

QUALIFICATIONS
Education and Licensure

• Bachelor of Pharmacy or Doctor of Pharmacy required
• Active North Carolina Pharmacist license, or immediate eligibility
• Willingness to obtain required non-resident pharmacist licenses

Experience and Skills

• Experience in sterile compounding within a regulated environment, hospital, 503A, or 503B
• Working knowledge of FDA 503B requirements, cGMP, DQSA, and USP 795, 797, 800.
• Strong understanding of aseptic processes and cleanroom operations
• Ability to supervise and guide production staff during sterile operations

Core Attributes

• Comfortable in a fast-paced startup environment
• Strong attention to detail and documentation accuracy
• Clear communicator with a collaborative, team-oriented mindset
• Committed to quality, compliance, and continuous improvement

EOE STATEMENT
We are an equal opportunity employer. We do not discriminate or allow discrimination on the basis of race, color, religion, creed, sex (including pregnancy, childbirth, breastfeeding, or related medical conditions), age, sexual orientation, gender identity, national origin, ancestry, citizenship, genetic information, registered domestic partner status, marital status, disability, status as a crime victim, protected veteran status, political affiliation, union membership, or any other characteristic protected by law.