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 generated in the Analytical Laboratory. The candidate will also generate and review analytical method validation/transfer protocols and manage laboratory supplies for method transfer/validation. Additionally, 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 to support day-to-day laboratory operations.
* Conduct 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 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 and Safety Statement.
* Report any defects or potential hazards.
Qualifications and Skills Required:
* Minimum of a 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, continuous improvement, troubleshooting, tech transfer, operations, and risk analyses/FMEA for drug substances (small molecules) and drug products.
* 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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