Work at Aurora Pharmaceutical
Aurora Pharmaceutical is equipped to be on the cutting edge of animal medicine. Explore your opportunity to be a part of a highly qualified team. Employees at Aurora are futuristic thinkers, wanting to be ahead of the change, not behind it. If you feel you possess the same passion to lead and be at the forefront of animal medicine, please see the positions available below.
To apply for a position at Aurora Pharmaceutical, please send resume to Hrdept1@aurorapharmaceutical.com
No calls please. Relocation expenses are not available.
Production Technician
Job title: Production Technician
Supervisor: Production Manager
Position Purpose: Manufactures pharmaceutical products according to SOPs, GMP and batch record specifications. Performs the day to day activities of the production process including weighing, blending, filling and packaging products. Collaborates with other production staff and other departments.
Job Responsibilities
(Essential job functions noted *
- Works all areas of production operation: weighing, blending, filling, packaging, cleaning*
- Accurately weighs product*
- Blends product according to batch record and SOP*
- Accurately fills and packages materials*
- Cleans equipment and rooms to specifications*
- Regularly inspects equipment for proper functioning*
- Meets productivity and production schedules and deadlines.*
- Troubleshoots process/production problems.*
- Assists with inventory duties such as receiving, product retrieval and shipping.
- Safely operates forklift*
- Complies with established standard operating procedures, cGMP quality standards and regulatory procedures*
- Accurately and consistently completes and documents batch records and other required paperwork*
- Precisely follows work orders and specifications*
- Adheres to all plant safety policies and procedures*
- Assists in set up, change over and test runs of equipment for various sized batches and various products
- Effectively communicates with other production employees and with all levels of management*
- Promotes a positive can-do attitude*
- Collaborates in cross functional teams*
- Consistently follows all company policies & procedures. *
- Performs other duties as requested
- Meets the following physical requirements:*
Sits, bends, stands, walks 90% of the time*
Repeatedly lifts or pushes a cart with 35-80 lbs*
Able to pass a respirator health test
Willing to wear required PPE
Qualifications – Education and Experience
- 1+ years experience in pharmaceutical or food manufacturing in compliance with 21CFR Part 211–Current Good Manufacturing Practice *
- Must be willing to work first or second shift and weekends if needed. *
- Flexible and open minded to suggestions from others; keen vision for continuous improvement.*
This job description is subject to change at the sole discretion of Aurora Pharmaceutical, LLC.
Quality Assurance Manager
Job title: Quality Assurance Manager
Reports to: Quality Control Manager
Purpose: The Quality Assurance (QA) Manager will ensure that products developed are of high quality and all related materials, processes and personnel comply with the requirements of relevant regulatory authorities. The QA Manager will collaborate closely with all functional units in the organization. He/she will coordinate and implement the oversight and improvement of new and existing quality systems. The QA Manager will implement and oversee the site sterility assurance programs and microbiological testing.
Duties & Responsibilities:
- Establish and ensure appropriate quality systems are implemented and maintained, including ongoing data analysis of product and process outputs to ensure early detection and response to quality improvement opportunities and prevention of quality issues*
- Provide coaching and mentorship to the quality team, ensuring appropriate levels of accountability for quality decisions and clearly communicates cross-functionally within the organization*
- Manage all aspects of plant quality systems, including document control, deviations, CAPA, supplier quality, change control, quality assurance, finished product review and release*
- Work with other quality/compliance, manufacturing, warehouse, purchasing and finance managers and personnel to effectively create and support process and quality enhancement initiatives*
- Support an aggressive quality program, which instills personal accountability for accuracy, consistency and completeness for all operations and departments according to site and corporate policies*
- Create and maintain an environment of excellence, world-class quality and continuous improvement throughout the entire plant
- Author, approve and/review area quality deviations and investigation reports as appropriate*
- Ensure on-time completion of all corrective action items*
- Prepare annual reports and conduct internal/external audits to assure cGMP compliance.*
- Identifies and defines acceptable aseptic manipulations, and interventions and the associated controls, to be used in manufacturing processes based on risk analysis*
- Provides oversight of the site integrated sterility assurance programs including: aseptic process simulations, cleaning / sanitization programs, sterility assurance risk assessment strategies and development of sterile projects*
- Serves as a sterility assurance subject matter expert*
- Oversee and monitor facility-wide training including awareness of company quality policies and cGMP training as well as maintain training curriculum and documentation for staff.
- Supervise, coach and develop staff. Complete regular performance evaluation of staff including the identification of development needs.*
- Extensively interact with all levels of personnel to resolve quality issues.*
- Collaborates in cross-functional teams*
- Follows all Aurora Pharmaceutical policies, procedures, regulations and the employee handbook.*
- Assumes additional responsibilities as requested.
- Demonstrates flexibility, i.e. willingly takes on new tasks.*
- Prioritizes projects and meets deadlines *
- Clearly and accurately communicates with all levels of employees*
(* denotes essential job functions)
Knowledge, Skills & Abilities:
- Strong working knowledge of FDA requirements and guidance documents
- Excellent written, verbal and presentation skills
- Highly organized, approachable, flexible and able to respond to changes in a dynamic environment
- Extremely detail oriented
- Expert knowledge of cGMP requirements
- Strong knowledge of process and computer validation requirements
Education:
- Bachelor of Science in Chemistry or Microbiology. Master’s degree preferred.
- 4 years of experience within the pharmaceutical or biotechnology industry preferred
- Prior experience in managing inspections performed by FDA and other regulatory authorities.
- Previous supervisory experience required
- Lean/Kaizen/Six Sigma working knowledge preferred
- Microbiological/environmental monitoring and trending experience in a highly controlled drug manufacturing environment, including sterile fill is desirable
Engineer
Job title: Engineer
Reports to: Engineering Manager
Position Purpose: Design and install pharmaceutical processes in a cGMP environment. Assists maintenance with the repair of pharmaceutical manufacturing equipment and the facility. Develops and implements solutions to insure continued and efficient equipment operations. Participates in process improvement initiatives related to equipment and processes. Writes and executes IQ, OQ, PQ and validations.
Job Responsibilities:
- Sets up machines and equipment for production processes. *
- Inspects machines for proper functioning. *
- Diagnoses equipment problems*
- Investigates equipment failures and difficult to diagnose faulty operations and makes recommendations for improvement*
- Assists maintenance with equipment repairs. *
- Trains other employees on proper use and setup of machines and equipment*
- Complies with established standard operating procedures, cGMP quality standards and regulatory procedures. *
- Creates and updates SOPs (Standard Operating Procedures). *
- Creates and updates equipment and facility drawings. *
- Determines how key quality attributes can be influenced by processing and can be controlled. *
- Assists with new equipment installations*
- Writes and executes IQ, OQ, and PQs*
- Writes and executes validations*
- Sets up calibrations*
- Sets up PMs (Preventive maintenance) *
- Precisely follows work orders and specifications*
- Adheres to all plant safety policies and procedures*
- Effectively communicates with other production employees and with all levels of management*
- Promotes a positive can-do attitude*
- Collaborates in cross functional teams*
- Flexible and open minded to suggestions from others; keen vision for continuous improvement.
- Consistently follows all company policies & procedures.
- Meets the following physical requirements:
*Stands, walks 50% of the time
Repeatedly lifts or pushes a cart with 30-70 lbs - Performs other duties as requested
(* denotes essential job functions)
Qualifications – Education and Experience:
- 2-3 years CAD experience
- Bachelor’s degree in Engineering. *
Equal Opportunity Employer