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Qc Senior 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.**

To ensure that all raw materials, packaging materials, stability samples, bulk and finished products are tested in accordance with validated and approved methods, procedures and specifications to assure Elanco New Zealand manufactured products are fit for intended use.

This position provides guidance and support to the QC Analysts on any technical issues that may arise during testing and coordinates activities with the QC Manager to ensure Key Performance Indicators are met.

**Responsibilities**:

- Plan and schedule work for the Quality Control analysts based upon the manufacturing schedule and the stability program, considering any requested priorities from Supply Chain Management.
- Take personal responsibility 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.
- Complete all testing of incoming raw materials, packaging materials, stability samples, bulk and finished products 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.
- Resolve any technical problems during testing to enable the timely
- analysis of samples by providing a senior level of expertise and advice to QC analysts on any testing issues.
- 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.

**Basic Qualifications**:

- Tertiary qualification with an emphasis on Chemistry, Biochemistry or Chromatography.
- Minimum of 5 years work experience working in an analytical laboratory with practical HPLC experience including trouble-shooting and method validation.
- Experience in Pharmaceutical industry.

**Additional Skills & Preferences**:

- A thorough understanding of GMP and GLP.
- Computer literate especially with Microsoft Office suite.
- Excellent planning, organizational and time management skills.
- Strong problem-solving skills, including Out of Specification
- An understanding of validation requirements including pharmacopoeia and ICH requirements.
- Knowledge of global and local veterinary and pharmaceutical regulatory requirements is desirable
- Strong written, oral and collaborative skills to effectively communicate quality information and requirements to employees at all levels

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