Pharmacist

pharmacist – quality assurance

This description is intended to be illustrative of the major duties performed by the employee assigned to this position. Performs other duties as assigned.

General Description

This position will report directly to the Pharmacist-in-Charge. The pharmacist is responsible for applying clinical knowledge to appropriateness of formulation, processes, and procedures related to sterile pharmaceutical manufacturing and related activities in a 503B Outsourcing Facility.

Quality Assurance pharmacists work collaboratively with other pharmacists, technicians, and various staff members to manufacture sterile drug products to fill customer orders in compliance with all regulatory requirements and company policies and procedures.

Essential Functions

• Review and verify formulation (compounding) activities and documentation performed by technicians and other support staff for completeness, accuracy, and adherence to cGMPs.
• Perform the final review and release of batches.
• Ensure compliance with all federal, state, and local regulations related to facility activities.
• Create/update product labels and determine appropriate label content per applicable regulations.
• Train manufacturing technicians to perform pharmaceutical calculations.
• Perform clinical product complaint and adverse drug event investigations.
• Write and/or review Standard Operating Procedures (SOPs) and deviations.
• Perform DEA recordkeeping and regulatory reporting activities to ensure compliance with all federal and state regulations.
• Participate in internal audits, regulatory inspections, and customer audits as necessary.
• Answer clinical questions from physicians, nurses, and other healthcare providers.
• Work collaboratively with members from various teams to achieve company goals.

sUPERVISORY RESPONSIBILITIES

• None

Experience and Necessary Skills

• Familiarity & Understanding of Sterile Manufacturing/Processing (USP testing, sterilization techniques, etc.) preferred
• Familiarity & Comprehension of regulations including DQSA, 21 CFR 211 and USP guidelines, as applicable.
• GMP and/or pharmaceutical industry experience preferred
• Good IT skills, including but not limited to Word, Excel, PowerPoint
• Excellent interpersonal and communication skills, both verbal and written
• Ability to assume responsibility and act on own initiative
• Good self-management, organizational and planning skills
• Ability to adhere to strict deadlines and procedures
• Excellent reasoning and critical thinking skills
• Hands- on approach with a “can-do” attitude
• Good listener, but proactive in group discussions

Requirements

• PharmD required.
• Maintain Pharmacist Licensure in state of facility and additional states if applicable, as assigned.
• Experience in a pharmacy compounding environment and/or pharmaceutical manufacturing facility preferred.
• Able to lift up to 20 lbs, stand for extended periods of time when required, and gown into an ISO 8 cleanroom environment.

3:30 PM - 12:00 AM (second shift)