Description
Corporate Statement
Nephron Outsourcing Facility is a 503B outsourcing facility dedicated to creating the highest quality compounds by maintaining current good manufacturing practices to and above the standards set by the FDA.
Position Summary:
- Compounds sterile products using either bulk or pre-sterilized materials utilizing aseptic technique.
- Assists with additional work duties or responsibilities as evident or required.
- Performs other duties as assigned or apparent.
Primary Accountabilities:
NOTE: The primary accountabilities below are intended to describe the general content of and requirements of this position and are not intended to be an exhaustive statement of duties. Incumbents may perform all or most of the primary accountabilities listed below. Specific tasks or responsibilities will be documented in the incumbents’ performance objectives as outlined by the incumbents’ immediate supervisor or manager.
- Prepare cleanrooms for compounding activities.
- Sanitize and inspect materials.
- Perform sterile compounding operations consistent with established protocols, procedures, and cGMP requirements.
- Perform weighing, measuring and addition of raw materials.
- Perform filter integrity testing after sterilizing activities.
- Receive and order sterile compounding supplies and production components.
- Assist in formulation development activities
- Assist with cleanroom cleaning and maintenance as appropriate or required.
- Maintain proper documentation of all compounding activities consistent with established GDP policies and procedures.
Knowledge, Skills & Abilities:
- Minimum of High School Diploma or equivalent with Associates or Bachelor’s Degree preferred
- Prior pharmaceutical experience preferred
- Strong attention to detail, good math skills, and knowledge of Metric System.
- Willingness to participate in training and gain other certifications as needed
- Expertise and skills with handling and mixing of chemicals through education and experience preferred.
- The ability and willingness to change direction and focus to meet shifting organizational and business demands.
- The ability to manage a multitude of resources and to be organized, accurate, and current with data and information.
- Position requires bending, typing, climbing, lifting (up to 15lbs), reaching, vision (20/20 corrected), standing, sitting, walking, and hearing.
- Incumbents are required to wear respiratory protection, laboratory coat, hearing protection, cleanroom gowns and other non-specified protective equipment as necessary.
- Must be able to work individually and on a team.
- The ability to create and contribute to an environment that values people, encourages trust, teamwork, and open communication, and provides participation, learning, feedback and recognition.
- The ability to effectively manage one’s self, demonstrates integrity, be productive under pressure, and achieve development goals.
- Salary range: Based on experience
EEO Statement:
Nephron is an equal employment opportunity employer and does not discriminate against employees or job applicants on the basis of race, religion, color, sex, sexual orientation, gender identity, age, national origin, disability, status as a protected veteran, pregnancy, marital status, genetic information, childbirth, medical needs arising from pregnancy and childbirth and related medical conditions, including lactation, or any other consideration made unlawful by applicable federal, state or local law.
Nephron Pharmaceuticals is a drug free workplace.