Quality Assurance Associate - Quality Control

The Quality Assurance Associate – Quality Control (QC) is responsible to oversee the Quality Assurance (QA) responsibilities for the Quality Control laboratories, to provide daily assistance and guidance to issues such as non-conformance investigations, change controls, quality training, review and approval of documents and to ensure the adherence to Elanco Quality standards and Regulatory agencies. The QA Associate works as a team member within the quality control teams to achieve site goals while maintaining a strong quality mindset.

Job Responsibilities

• Provide routine and non-routine quality oversight and guidance for the quality control clinical and laboratory teams area, 24/7
• Provide a daily presence in the quality control environment to enable contemporaneous testing record review, provide quality expertise to laboratory personnel, and conduct trainings to QC personnel on quality topics
• Responsible for review and approval of QC documents, including but not limited to QCPs, SOPs, forms, protocols and reports
• Assist with review of laboratory materials, semi-finished (antigen), and finished materials (vaccine) testing records and summaries.
• Support during internal/external regulatory inspections
• Assess non-conformances that occur within QC and assist with assay disposition, retests, and investigation
• Function as a quality partner, providing guidance to persons writing change controls, impacting QC; responsible to ensure investigations and change controls meet standards
• Perform testing process confirmation against QC procedures and practices
• Mentor and coach site personnel on Quality matters
• Maintain a general working knowledge of manufacturing process, quality systems and QC testing procedures.
• Participate and support regulatory and technical teams in new product and assay development, product and assay transfers, technical improvements, product registrations and regulatory reviews
• Other duties as assigned

Basic Minimum Qualifications:

• B.S. Degree in Microbiology/Biology/Chemistry/Engineering (Science or Engineering related degree preferred) or equivalent experience in lieu of degree
• 3 years in a Quality Control or Quality Assurance related role
• Root cause analysis, troubleshooting and technical writing skills
• Strong interpersonal and team building skills; ability to lead through influence in a team environment
• Qualified candidates must be legally authorized to be employed in the United States. Elanco does not anticipate providing sponsorship for employment visa status (e.g., H-1B or TN status) for this employment position.

Additional Preferences:

• M.S, is highly desirable
• Familiarity with USDA regulations and 2008 submission process and standards
• Proficiency with applicable computer systems, such as SAP, Veeva and Microsoft Office
• Knowledge of or experience in Lean, Six-Sigma or Operational Excellence
• ASQ certification a plus.
• Experience working in an FDA or USDA regulated industry
• Excellent communication, organization, and leadership skills

Other Information:

• Off hours and weekend work may be required
• Potential exposure to chemicals, allergens, and loud noises
• Personal Protective Equipment (PPE) and clean room environment may apply.

Job Type: Full-time

Pay: From $59,500.00 per year

Benefits:

• 401(k)
• 401(k) matching
• Dental insurance
• Employee assistance program
• Employee discount
• Flexible schedule
• Flexible spending account
• Health insurance
• Health savings account
• Life insurance
• Paid time off
• Parental leave
• Professional development assistance
• Referral program
• Relocation assistance
• Tuition reimbursement
• Vision insurance

Schedule:

• 8 hour shift
• Day shift
• Monday to Friday

Ability to commute/relocate:

• Webster City, IA: Reliably commute or willing to relocate with an employer-provided relocation package (Required)

Work Location: One location

Salary : $59,500 - $0