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Qc Analyst

2 weeks ago

Auckland City, New Zealand Elanco Full time

Education : EQUIVALENTEXPERIENCE

**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 Summary**

The Quality Control Analyst has a vital role to play to ensure that Elanco products manufactured at the Manukau site are fit for intended use.

Reporting to the Quality Control Manager, you will ensure all raw materials, packaging materials, stability samples, bulk and finished products are tested in accordance to validated and approved methods, procedures and specifications.

**Responsibilities**:

- Responsible for your own safety and in ensuring safe working practices are followed in the laboratory to create a safe working environment for all staff by wearing correct Personal Protective Equipment at all times and any identified risks are reported
- Analyze samples in a timely manner to meet laboratory key performance indicators and customer needs by performing analysis according to the laboratory schedule and relevant Quality Control documentation and prompt review of results.
- Provide a prompt investigation of all Quality Control out of specification results to enable the release of test results within agreed timeframes by ensuring investigations and corrective and preventative actions are completed by their due date.
- Conduct all routine analysis and with adherence to Quality Control procedures to remain in compliance and deliver accurate results by following local standard operating procedures, Good Manufacturing Practice, Good Laboratory Practice and site Quality Systems.
- Assist in the development of standard operating procedures and test methods to ensure the Quality Control documents are accurate and within their review date by drafting documents and reviewing documents as assigned.
- Assess that all equipment is qualified and calibrated according to standard to ensure accurate test results are generated by reviewing equipment status before use and reporting any deviations to the Quality Control Manager.

**Basic Qualifications**:

- Minimum BSc in chemistry or equivalent tertiary qualification.

**Additional Skills & Preferences**:

- Work experience working in an analytical laboratory with practical HPLC experience including troubleshooting and method validation would be an advantage.
- A thorough understanding of GMP and GLP as well as validation requirements including pharmacopoeia and ICH requirements is desirable.
- Computer literate especially with Microsoft Office suite
- Excellent planning, organization and time management skills
- Strong problem-solving skills, including Out of Specification investigations.
- Strong written, oral and collaborative skills to effectively communicate Quality information and requirements to employees at all levels

**Additional Information**:

- In this role, you may have direct interaction with regulatory agencies during site inspections.
- Tasks may require handling hazardous or other dangerous materials.

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