- Hiring diverse talent
- Maintaining an inclusive environment through persistent self-reflection
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- Ensuring growth opportunities for our people
Senior Analyst Bioassay - Durham, United States - Actalent
Description
Description:
The Senior Associate will support the overall management and delivery of phase appropriate analytical method verification/qualification/validation and method transfer between stakeholders of our client and their customers. Ensure that all aspects of method lifecycle are conducted at the site in compliance with cGMP regulations, relevant compendial requirements, company policies, standards and procedures and safety standards. Will support all site activities to ensure timely and successful execution of method lifecycle activities at the site. Specific activities include authoring/executing/review of study design, protocols and reports associated with analytical method qualification/validation/transfer. 70% of time will be executing studies outlined in protocols.
Job Responsibilities (core responsibilities; include people management if applicable)
• Support the site's Analytical Method Lifecycle program encompassing all Quality activities to support method transfers and validation.
• Interface directly with client stakeholders for quality or compliance issues associated with analytical methods.
• Contribute to product specification development and ensure alignment with method capabilities.
• Support QC method/analytical investigations (OOS/OOT) at the site.
• Review and approve SOPs as required.
• Performs all other related duties as assigned.
Additional Skills & Qualifications:
5+ years of cGMP bioassay experience, method development and validation
cSDS page - nice to have
Experience Level:
Intermediate Level
About Actalent
Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.
Diversity, Equity & Inclusion
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