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As a Quality Assurance Senior Associate you will provide support for Clinton Manufacturing Operations and maintain quality systems and GMP compliance. The QA Representative will:
- Provide production floor support by give assistance and guidance in procedure and master formula revisions, Annual Product Reviews, quality system monitoring (water, stability), and validation.
- Maintain GMP compliance and in the preparation for inspections by various regulatory agencies.
- Facilitate continuous improvement by coaching, authoring and supporting deviation investigations and change control proposal implementation.
- May be responsible for the batch release of material intended for market distribution.
Minimum Basic Qualifications:
- Bachelor’s Degree
- Strong written and verbal communications skills
- Excellent interpersonal skills and networking skills
- Ability to organize and prioritize multiple tasks
- Ability to work independently, decision making, and attention to detail, computer applications, statistical analysis, and problem solving.
- Will need to work in areas manufacturing animal health products.
The responsibilities of the Quality Assurance Representative include:
- Support production floor operations or support group operations
- Oversee the batch release of raw materials
- Investigate out-of-specification or out-of-trend data
- Review and approve master formulas and production related protocols
- Review area procedures, drawings, change proposals, and deviations.
- Approve operations procedures and drawings
- Approve Level 1 deviations and changes
- Participate in area process teams
- Attend and contribute to production morning meetings
Maintain and improve site Quality Systems:
- Write or revise standard operating procedures related to Quality Assurance operations
- Write and revise training associated with Quality Assurance operations
- Deliver training to site personnel on quality related topics
- Maintain and improve Quality Systems and serve as site representative for corporate committees or knowledge transfer (as designated by management)
- Facilitate change implementation while ensuring compliance to applicable cGMP’s and Elanco Quality Systems
- Provide coaching and feedback to operational staff
- Perform periodic audits and inspections of production areas to ensure GMP compliance and inspection/audit readiness
- Investigate customer complaints
- Author, provide input and review validation, annual product review (APR) and Periodic Quality Evaluation (PQE) documents
This job description can be assigned with or without batch release responsibility. If batch release responsibility is included:
- Perform batch release for final products and APIs intended for market distribution.
- Perform and ensure daily coverage of batch release activities.
- Participate in training and mentoring other Quality Assurance representatives responsible for batch release.
- Experience in QA, QC, Engineering, Manufacturing Science & Technology, or Regulatory is desirable.
- Prior Quality Assurance experience preferred.
- Must complete required batch release training prior to release of final batches
Elanco is an EEO/Affirmative Action Employer and does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status