What are the responsibilities and job description for the Quality Manager position at Scientific Search?
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
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
- 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
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