Job Description
Pharmacist Position
The Pharmacist is responsible for supporting Medivant Healthcare's sterile injectable manufacturing operations while ensuring compliance with FDA regulations, USP 797, USP 800, cGMP requirements, and internal quality standards. This role provides oversight of sterile compounding activities, batch record review, labeling verification, cleanroom operations, regulatory compliance, and quality documentation.
The Pharmacist will work closely with Production, Quality Assurance, and Regulatory teams to maintain product quality, manufacturing compliance, and operational excellence. The ideal candidate is a licensed pharmacist with experience in sterile compounding, pharmaceutical manufacturing, or 503B outsourcing facilities and possesses a strong understanding of sterile operations and regulatory requirements.
Key Responsibilities
Sterile Compounding & Manufacturing Oversight
- Oversee sterile compounding and aseptic filling operations to ensure compliance with USP 797, USP 800, and cGMP requirements.
- Monitor cleanroom operations, gowning practices, environmental controls, and aseptic techniques.
- Verify formulation calculations and compounding accuracy.
- Ensure adherence to established manufacturing procedures and standard operating procedures.
- Provide guidance and support to technicians and manufacturing personnel on sterile compounding best practices.
Batch Record Review & Documentation Compliance
- Review and approve batch production records, labels, and associated manufacturing documentation.
- Ensure accurate completion and maintenance of production and quality records.
- Verify product labeling and documentation accuracy prior to release activities.
- Maintain documentation in accordance with regulatory and company requirements.
- Support data integrity and documentation compliance initiatives.
Quality & Regulatory Compliance
- Ensure compliance with FDA regulations, DEA requirements, USP standards, state pharmacy board regulations, and internal quality systems.
- Support internal audits, customer audits, and regulatory inspections.
- Participate in investigations, deviations, CAPA activities, and corrective action implementation.
- Assist with validation, qualification, and continuous improvement initiatives.
- Collaborate with Quality Assurance to maintain inspection readiness and regulatory compliance.
Cross-Functional Collaboration
- Partner with Production, Quality Assurance, Validation, and Regulatory Affairs teams to support manufacturing operations.
- Support process improvements that enhance product quality, compliance, and operational efficiency.
- Provide technical expertise related to sterile manufacturing and pharmacy regulations.
- Assist in evaluating operational risks and identifying compliance improvement opportunities.
Qualifications
Required:
- Active Pharmacist License in the State of Arizona in good standing.
- Minimum 2 years of experience in sterile compounding, pharmaceutical manufacturing, hospital pharmacy, or a 503B outsourcing facility.
- Strong knowledge of USP 797, USP 800, cGMP requirements, and FDA regulations.
- Experience reviewing manufacturing documentation and batch production records.
- Strong analytical, problem-solving, and attention-to-detail skills.
- Excellent verbal and written communication abilities.
- Ability to work effectively in a regulated pharmaceutical manufacturing environment.
Preferred:
- Experience in sterile injectable pharmaceutical manufacturing.
- Experience supporting FDA inspections and regulatory audits.
- Familiarity with LIMS, ERP, electronic batch record systems, or quality management systems.
- Previous experience within a 503B outsourcing facility.
- Experience with validation, deviation investigations, and CAPA processes.
Key Competencies
- Sterile Compounding & Aseptic Processing
- USP 797 & USP 800 Compliance
- Pharmaceutical Manufacturing Operations
- cGMP Compliance
- Batch Record Review & Documentation Control
- Quality Assurance & Regulatory Compliance
- FDA & DEA Regulatory Knowledge
- Investigation & CAPA Management
- Attention to Detail
- Risk Assessment & Problem Solving
- Cross-Functional Collaboration
- Process Improvement
- Technical Leadership
- Communication & Documentation Skills
What Success Looks Like
- Maintain full compliance with USP, FDA, DEA, and company quality requirements.
- Ensure accurate review and approval of batch documentation and manufacturing records.
- Support successful regulatory inspections and internal audit outcomes.
- Maintain high standards for sterile compounding and aseptic manufacturing practices.
- Contribute to continuous improvement initiatives that enhance compliance, efficiency, and product quality.
- Serve as a trusted technical resource for pharmacy, manufacturing, and quality teams.
- Support Medivant Healthcare's mission of providing high-quality, affordable sterile injectable medications to healthcare providers nationwide.
Schedule: Morning 04-05 Hours.
Medivant Healthcare
Job Tags
Day shift