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As an Analytical Analyst, you'll play an important role in the day-to-day operation of the Analytical laboratory and supporting site activities.
Position Summary:
The Analytical Analyst reports to the Quality Control Manager and is responsible for analytical method transfers, and method validations/verifications, with minimum supervision. The candidate will be responsible for troubleshooting any OOS/OOT results that are generated in the Analytical Laboratory. The candidate will be responsible for generating and reviewing analytical method validation/transfer protocols and managing laboratory supplies for method transfer/validation. The candidate will help prepare and maintain an inspection-ready status within the laboratory to support regulatory audits. Experience with analysis of biologics including bioassays is highly desirable.
Responsibilities:
* Perform routine analytical activities as required to support day-to-day laboratory operations.
* Perform analytical testing.
* Prepare and execute method transfer protocols and generate reports.
* Be actively involved in internal investigations e.g. Laboratory Out of Specifications, Incidents & Deviations etc.
* Ensure that all work is carried out in compliance with the required company standards and conforms to cGxP, relevant SOPs, and safety and environmental guidelines.
* Identify continuous improvement opportunities.
* Implement Health & Safety requirements as per site documentation including SOPs, Safety Statement.
* Report any defects or potential hazards.
Qualifications and Skills Required:
* Minimum of bachelor's degree in pharmaceutical sciences/chemistry or chemical/bioengineering.
* 5 years' experience in the pharmaceutical industry.
* Experience in analytical method development, method validations, optimization, troubleshooting, tech transfer, operations, risk analyses/FMEA for drug substance (small molecules), drug product.
* Data analysis and presentation skills.
* Problem-solving skills.
* Understanding of US, EU, and ICH Good Manufacturing Practices regulation concepts.
* Demonstrated leadership in a fast-paced company.
* Team player.
* Ability to communicate clearly and concisely verbally and in writing.
* Willingness to work in the laboratory as required.
* Proficient in Microsoft Office.
* Strong interpersonal skills.
* Excellent written and verbal communication skills.
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