Quality Investigations Engineer - Lincoln, NE

Quality investigations Engineer Location: Lincoln, NE Expense Reimbursements: Lodging (directly paid by client), Rental Car (directly paid by client), 1 Flight per month round trip reimbursed on receipt with 1 checked bag, Up to $40 per day reimbursed on receipt for food. Job Description The Quality Assurance Specialist IV is a role in which consultants are responsible for providing system-wide quality implementation and process improvement /Investigation. Your responsibilities may include: Qualifications:

• We are looking for consultants with 9-12 years' experience in either a laboratory or manufacturing FDA regulated environment as a quality specialist.
• Experience working on a manufacturing floor (solid dosage in this case).
• Evidence of good oral and written communication skills, i.e. effective presentation of concepts and ideas, as well as interpersonal and conflict resolution skills.
• Attention to detail, flexibility and an awareness of production and attendant quality control problems.
• Knowledge of cGMPs and of regulatory requirements as they apply to the pharmaceutical field or a related area.

• Bachelor's degree in biology or a related discipline
• OR demonstrated relevant experience meeting the above listed qualifications

• Perform critical investigations according to the needs of the management team
• Write and submit investigations as well as deviation reports
• Perform Quality batch record review and approval

• Perform critical site reviews for per process environmental monitoring

• Collaborate with Planning, Operations and Technology organizations to ensure batches are ready for release by appropriate due dates

• Perform GMP walk through inspections of assigned departments within the IPT to ensure compliance with cGMPs and regulatory requirements

• Supports and maintains the quality system and is able to make quality system recommendations following through to implementation to address issues found (CAPA, NCR)
• Works interdepartmentally to resolve issues related to material and process quality