What are the responsibilities and job description for the Staff Pharmacist - 2nd Shift position at Fagron Sterile Services US (FSS)?
About the Job
The Staff Pharmacist (2nd Shift) responsibility is to ensure adherence to facility SOP's and procedures, and adherence to state and federal regulations. The Staff Pharmacist will assist with investigations and assist in daily operational pharmacy duties within the post-production (visual inspection and labeling) and order fulfilment departments.
Key Responsibilities
- Responsible for the execution of opening and closing activities, as needed.
- Ensure strict procedures are followed around the facility.
- Identify trends or issues that are delaying batch production or causing batches to be cancelled.
- Writing operational and production SOP's.
- Liaison with the aseptic operations and quality departments.
- Maintain compliance with all state and federal regulatory agencies.
- Assist in documentation and completion of Adverse Drug Event forms.
- Answer clinical questions from health professionals and provide product information.
- Support order verification within computer order processing queue to ensure facility and product accuracy.
- Review of all batch records and associated documentation verification.
- Ensuring safe work environments, enforcing operational discipline, and monitoring aseptic behaviors.
- Understanding of the importance/impact of cGMP standards.
- Maintain state pharmacy license(s).
Basic Qualifications
- The Staff Pharmacist shall maintain at all times a pharmacist license in the state of Kansas that is in good standing and current.
- Obtaining licensure in other states may be required to fulfil state specific regulatory obligations.
- 2 years pharmacy experience and a good understanding of quality and compliance requirements pertaining to cGMP and 21 CFR 210 & 211.
- Prefer experience with a manufacturing environment.
- Proven effective verbal and written communication skills
- Experience working with standard ERP/MRP systems.
- Experience interpreting compliance requirements and regulations is required.
- Knowledge of DEA, FDA and state regulations pertaining to manufacturing and handling of controlled substances.
- Capable of lifting up to 50 pounds, standing for extended periods of time and shall have no allergies to chemicals that might be used during compounding.
- Ability to read, analyze, and interpret common scientific and technical journals, financial reports, and legal documents.
- Ability to respond to common inquiries or complaints from customers, regulatory agencies, or members of the business community.
- Ability to define problems, collect data, establish facts, and draw valid conclusions.
- Ability to interpret an extensive variety of technical instructions in mathematical or diagram form and deal with several abstract and concrete variables.
- Able to establish robust processes, develop performance standards, track performance through fact driven exercises, and implement solutions to drive continuous process improvements.
- Demonstrates skills to solve complex problems in a wide variety of high pressure situations which require a high degree of ingenuity, creativity and innovativeness.
- In situations where precedent may not exist, is able to independently exercise judgment, determine appropriate solution and take action.
- Demonstrates a strong ability to be adaptable and flexible.