(Archived) Senior Associate-Quality Assurance

As a leading global animal health company, Elanco delivers innovative products and services to improve the health of pets and farm animals around the world because we believe making animals' lives better, makes life better. Since 1954, we have provided solutions that support veterinarians, farmers and pet owners to advance our vision of Food and Companionship Enriching Life. Elanco's promise to employees: Together, we foster an inclusive culture where everyone can make a difference, encouraging ownership, growth and well-being.

Position Description:

To provide support for Clinton Manufacturing Operations and maintain quality systems and GMP compliance. The QA Representative will:

Provide production floor support by giving assistance and guidance in procedure and master formula revisions, Product Quality Reviews, quality system monitoring (water, stability), and validation. Maintain GMP compliance 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 Qualification (education, experience and/or training, required certifications):

• Strong written, interpersonal and networking skills; ability to organize and prioritize multiple tasks; ability to work independently; strong decision-making skills; knowledge in computer applications (Word/Excel/PowerPoint, Etc) and statistical analysis. Will need to work in areas manufacturing animal health products.
• Bachelor’s Degree- Science related field preferred.
• 3 years minimum experience.
• 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:

• 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 lots.
• Language requirements - English.

Key Objectives/Deliverables:

The responsibilities of the Quality Assurance Representative include:

Production Support

• 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 documents.
• Lead Investigator for deviations.
• Author change controls.
• Review and/or approve area procedures, drawings, change proposals, and deviations.
• Attend and contribute to area huddles and process teams.

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).

Continuous Improvement

• 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 documents, product quality review (PQR)) and Periodic Quality Evaluation (PQE) documents.

Notification of Drug testing and Background Checks

Elanco conducts urinalysis drug testing as a mandatory part of its pre-employment application and background check process after acceptance of a conditional offer of employment by an applicant. The drug testing will be conducted by a certified laboratory/testing service selected by Elanco, in accordance with the procedures required by applicable state and federal law. Additionally, Elanco requires successful completion of a urinalysis drug test if it has reasonable suspicion that an employee is under the influence of drugs or alcohol which adversely affects or could adversely affect the employee's job performance as allowed by applicable law. Tested applicants will be given a copy of any positive test result. All test results shall be considered confidential and shall not be disclosed by Elanco, other than to those persons for whom such disclosure is necessary. Positive test results, or a refusal to consent to and participate in pre-employment drug testing, shall be grounds for denial of employment. Cooperation in scheduling the testing is important for processing an application for employment. By signing your acceptance to an offer of employment, you consent to be drug tested and acknowledge you have thoroughly read the foregoing notice and policy, and you understand and agree that in order to be considered for employment with Elanco, you will be required to comply with Elanco's drug testing policy. Elanco's background check requirements also include but are not limited to an acceptable criminal background check, educational verification, job history verification and motor vehicle report (if required to drive a company vehicle). If appropriate for the role, as outlined on the job posting, successful completion of Post Offer Exam, Work Simulation and/or Administrative Skills Testing may also be required.

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