Quality Manager

Doniphan, NE

Company Profile

A leader in sterile fill manufacturing supplying the animal health industry throughout North America with life sustaining fluids.

What You Can Expect To Be Doing

• Develop, revise and implement procedures and practices used in a GMP aseptic fill manufacturing facility.
• Be responsible for day-to-day Quality functions and the management of staff, including hiring, training and coaching employees to ensure the duties are completed in a timely and accurate manner.
• Understand the concept of Laboratory Control (LC) functions and the manufacturing process.
• Work closely with other management and supervisors to ensure Quality System duties are completed and compliant.
• Oversee the Quality System’s participation in the Master Validation Plan, documentation, assist in new project implementation and develop GMP culture.
• Be familiar with FDA and industry guidelines and interpret them to provide GMP expertise to establish and determine manufacturing procedures, standards, and control points as appropriate based on established validated processes.
• Manage Quality System team and assign and monitor their responsibilities; provide assistance in areas of need
• Hire, fire, advance, promote or any other change of status of employees
• Performance evaluations and disciplinary actions
• Supervise technical staff in carrying out tests and checks
• Create or implement procedures to make sure regulatory compliance is sustained or enhanced. Establish, revise, and approve applicable Standard Operating Procedures and forms
• Communicate compliance information to multiple departments and ensure that information is interpreted correctly. Promote quality achievement and performance improvement throughout the organization.
• Administer compliance tasks:
• Document control and record review
• Cross functional documentation review
• Investigations such as deviations, OOS, and compliance. Follow through with assigned CAPA.
• Execute Master Validation Plan. Work with Project Manager for document review.
• Validations: aseptic, steam, terminal, cleaning, analytical
• Calibration program
• Quality oversight
• Personnel qualification
• Change controls
• Assist with internal and vendor audits
• Implement customer procedure and quality specifications
• Administer drug product recalls
  
  

What You Will Bring To The Table

• Bachelor’s degree in an applied science or engineering field
• Seven years prior experience in Quality Assurance GMP Regulated Industry
• Must have thorough understanding of FDA regulation and pertinent state and federal laws governing pharmaceutical products, manufacturing, and marketing
• Working knowledge of pharmaceutical manufacturing
• Three years of management experience
• Experience in quality management systems
• Experience in quality system audits
• Proficient in Microsoft Office
• Ability to read, write, speak, and understand English is necessary to perform the duties of this position
  
  

To learn more about this fantastic opportunity, please reach out to Tyler Finley at Tyler@ScientificSearch.com