This description is intended to be illustrative of the major duties performed by the employee assigned to this position. Performs other duties as assigned.
This position may report directly to the General Manager or a designated Quality Manager, as assigned. The pharmacist is responsible for applying clinical knowledge to appropriateness of formulation, processes and procedures related to sterile pharmaceutical manufacturing and related activities. Staff 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.
- Supervise, Review & Verify quality activities performed by technicians and other support staff. Such verifications may require cleanroom gowning attire and functions as necessary.
- Assist New Product Development/Technical Services Team as necessary.
- Writing and/or review Standard Operating Procedures (SOPs) as assigned.
- Participating in internal audits and regulatory inspections as necessary.
- Performing inventory control activities including check-in receipt, check-out release and routine maintenance of controlled and non-controlled drug substances for both raw materials and finished goods.
- Working collaboratively with members from various teams to achieve production goals.
- Understanding & complying with cGMP’s, company SOP’s and state-specific regulations at all times.
EXPERIENCE AND NECESSARY SKILLS:
- Familiarity & Understanding of Sterile Manufacturing/Processing (USP testing, sterilization techniques, etc.) preferred but willing to teach
- Familiarity & Comprehension of regulations including DQSA, 21 CFR 211 and USP guidelines, as applicable.
- GMP and/or pharmaceutical industry experience preferred but willing to teach
- 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
- Maintain Pharmacist License in state of facility and additional states if applicable, as assigned.
- Experience in a pharmacy compounding environment and/or pharmaceutical manufacturing facility.
- Able to lift up to 20 lbs and stand for extended periods of time when required.