You are applying for a position through Medix, a staffing agency. The actual posting represents a position at one of our clients.
Job Summary
The Pharmacist in Charge (PIC) plays a pivotal leadership role at our client in ensuring compliant, safe, and efficient production of sterile and non-sterile compounded drug products within a 503B Outsourcing Facility. This position requires deep expertise in FDA regulations specific to compounding, including cGMP (21 CFR Parts 210/211), USP <797>/<800>, DEA controlled substance handling, and state pharmacy laws. The PIC also leads the pharmacy and cleanroom teams in maintaining production quality, supporting regulatory readiness, and fostering a culture of compliance and continuous improvement.
Key Responsibilities
- Direct daily operations of sterile and non-sterile compounding within the 503B facility.
- Oversee compliance with FDA 503B requirements, cGMPs, USP standards, DEA rules, and state pharmacy laws.
- Implement and maintain quality improvement processes and workflow optimization.
- Ensure the proper handling and documentation of controlled substances in compliance with DEA requirements.
- Review and approve Master Batch Records (MBRs), Batch Production Records (BPRs), and all product release documentation.
- Lead efforts in environmental monitoring, cleanroom control, and aseptic process verification.
- Actively participate in internal and external audits and regulatory inspections.
- Direct training and competency evaluations for all cleanroom and compounding personnel.
- Maintain and update necessary state licenses and pharmacy permits for facility compliance across jurisdictions.
- Provide guidance on complex compounding and clinical issues to executive and quality teams.
Qualifications
- Doctor of Pharmacy (PharmD) or an advanced degree in a related scientific field.
- Licensed and in good standing with the appropriate State Board of Pharmacy.
- Controlled Substance License as required by jurisdiction.
Experience
- Minimum of 5 years of experience in sterile compounding, with at least 2 years in a leadership or supervisory role.
- Experience with analytical testing, formulation development, or stability studies is highly desirable.
Skills
- In-depth knowledge of FDA cGMP, USP <797>/<800>, and DEA regulations.
- Strong leadership, analytical, and interpersonal skills.
- Experience with sterile injectables and aseptic compounding practices.
- Proficiency in scientific technical writing and SOP development.
- Strong working knowledge of Microsoft Office and Quality Management Systems (QMS).
Additional Requirements
- Work may be performed in cleanroom, laboratory, office, or mechanical areas.
- Exposure to aseptic environments and hazardous drugs.
- Requires standing for extended periods and lifting up to 15 pounds.
- Compliance with gowning, environmental, and safety protocols associated with sterile manufacturing.
Benefits
- Paid Sick Leave (Medix provides paid sick leave according to state and local sick leave ordinances).
- Health Benefits / Dental / Vision (Medix offers 6 different health plans: 3 Major Medical Plans, 2 Fixed Indemnity Plans (Standard and Preferred), and 1 Minimum Essential Coverage (MEC) Plan. Eligibility for health benefits is based on verifying that an average of 30 hours per week during the first 4 weeks of the work assignment has been met. If you meet eligibility requirements and take action to enroll, you will be covered no earlier than 60 days into your assignment, depending on plan selection(s)).
- 401k (Eligible on the first 401k open enrollment date following 6 consecutive months on assignment. 401k Open Enrollment dates are 1/1, 4/1, 7/1, and 10/1).
- Short Term Disability Insurance.
- Term Life Insurance Plan.
Medix Overview:
With over 20 years of experience connecting organizations with highly qualified professionals, Medix is a leading provider of workforce solutions for clients and candidates across the healthcare, scientific, technology, and government industries. Through our core purpose of positively impacting lives, we’re dedicated to creating opportunities for job seekers at some of the nation's top companies. As an award-winning career partner, Medix is committed to helping talent find fulfilling and meaningful work because our mission is to help you achieve yours.
