Job Summary

Responsible for the accurate weighing, checking and mixing of specific chemical compounds for product formulations; the calibrating and monitoring of a variety of mixing machinery and the accurate documenting and maintaining of production logbooks and records. They’re also required to follow all departmental and company SOP’s and maintain accurate and timely record keeping on each formulation batch. They must be able to work with Antineoplastic products and assist in the Nanotechnology department

Responsibilities

1. Responsible for accurate formulation of all production lots
2. Sets-up, load, operate and monitor all mixing machine equipment for product formulations
3. Responsible to weigh out and mixing exact amounts of chemicals according to specific formulas while monitoring (verifying) product output from mixing equipment operations.
4. Calibrate, operate and monitor all formulation-related equipment (such as scales, meters, etc.).
5. Responsible for the operations necessary to adjust pH of product for in-process testing before releasing to production lines
6. Responsible for the operations necessary to adjust Oxygen levels of Oxygen sensitive product before releasing to production
7. Required to understand and support the formulation of batches using both a volumetric and gravimetric processes based on the requirements as specified in the individual batch records
8. Clean and sanitizes all tanks, equipment and chemical containers used in the product formulation process in accordance with current SOP’s and cGMP’s
9. Fills out forms for recording production volumes (batches) and complies with all current GDP standards
10. Assumes other duties and responsibilities, as necessary, within the compounding department, in an effort to provide the required support to ensure adherence to the production schedule

REQUIRED COMPETENCIES –KNOWLEDGE, SKILLS, ABILITIES
1. Job function requires strict adherence to safety requirements, SOPs, cGMPs, Batch Records and other controlling documentation. Inability to comply with safe work could result in serious injury to self-others or serious damage to equipment or destruction of product. Job function requires joint work efforts with others and ensuring group safety practices are met.
2. Job functions performed improperly could result in destruction of materials in excess of $10,000,000 and poses a health risk to self, others and end users of product. It is imperative that all issues be quickly and accurately communicated, addressed, and corrected to ensure product quality and personnel safety.

SPECIAL CIRCUMSTANCES – WORKING ENVIRONMENT/PHYSICAL REQUIREMENTS
1. Job functions require work in respirators, including half-mask and full forced air breathing apparatus. Work environment is clean but requires special gowning procedures. Position requires work in clean room environments where clean room clothing is required. Work with hazardous materials is required where improper handling and failure to comply with outlined procedure could result in exposure to Antineoplastic/hazardous products and raw materials that could lead to serious illness. All safety requirements will be adhered to and complied with.
2. Failure to comply with safe work practices and or inability to remain focused on responsibilities could result in serious injury. Proper training and understanding of the work requirement makes the possibility, likelihood, and risk of injury extremely low.
3. Job function requires high physical demand. Lift in excess of 75lbs, to move 55 gal drum on and of a pallet, ability to move or handle large motors, assemble and disassemble large pieces of equipment and tanks. All functions may occur on a daily basis.
4. Requires ability to mentally focus on duties and ability to stay mentally alert 100% of time. Due to nature of work, inability to maintain mental alertness could result in improper compounding or processing of product and injury to self or others.
5. Job function may require work site coordination of up to 3 individuals. Direct supervision in this position occurs less than 30%.

EDUCATION/EXPERIENCE REQUIREMENTS

• Person must have a high school diploma or GED.
• Person with experience working in, or around, pharmaceutical manufacturing related industries a plus.
• Ability to not only perform but understand and accurately weigh / measure chemicals in both powder and liquid form and have the ability to read and retain written SOP’s that are required within the formulation department.
  
  

Additional Information

We offer an excellent salary and benefits package including medical, dental and vision coverage, as well as life insurance, disability, 401K with company match, and wellness program.

Fresenius Kabi is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disabilities, or protected veteran status.