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Description:

This is a QC Analyst III Position

Reporting to the QC Manager, the QC Analyst III will be responsible for the execution of method transfer tests for new product development, new API sources, technical transfers and other related activities. The QC Analyst III is the subject matter expert responsible for the more complex analysis using various wet chemistry and instrumentation techniques to assure compliance to cGMP, SOPs and quality standards who will also provide training and technical support to other Analysts and Technicians as needed.

• Ensures that all work is carried out in compliance with company Safety policies, Good Manufacturing Practices (GMP/GLP) and Standard Operating Procedures (SOPs).
• Author, review and execute to method transfer protocols for new product introduction and compendial validation
• Ability to work directly from the USP or EP pharmacopeia to write protocols and execute methods.
• Expertise with analytical tests utilizing HPLC/UPLC, GC, UV, IR, FTIR, KF and other laboratory instruments.
• Assess, compare and perform risk assessments for compendial method compliance according to USP, EP, and other regulations.
• Assess analytical methods and perform gap analysis on analytical method validations for NPI. Develop plan and timelines for method transfers, required improvements and justification with approval from team to ensure compliance.
• Conducts complex analytical (physical & chemical) testing of raw materials, in-process samples, finished products required for method transfer and validation.
• Reviews laboratory documentation in notebooks, attachments, chromatography software and specification sheets for accuracy, completeness and compliance with established SOPs, specifications and methods.
• Conducts the investigation of deviations, out of specification (OOS), and non-conformances. Writes reports as required.
• Verifies and processes analytical data for method transfer. Writes technical documents such as methods, specifications, SOPs, method validation protocols and reports, method transfer protocols and reports.
• Participates in general lab duties, including clean up, administration, logbook review and operations support.
• Other duties as assigned.

Additional Skills & Qualifications:

Analytical Wet Chemistry Lab experience using the following methods/equipment: titration, pH, Potency, Conductivity, Viscosity, TOC, UV, IR, GC, HPLC assays

High integrity, excellent attention to detail, analytical thinker, ability to organize and prioritize, work in team environment and individually, and take initiative (can be verified by reference)

Strong problem identification and problem resolution skills

Excellent written and verbal communication skills for liaising and communicating with internal departments and external vendors

Strong work ethic and positive team attitude

Nice to Have:

Leadership experience

Technical writing experience

Troubleshooting Analytical equipment

Authoring and executing method transfers and protocols

Diversity, Equity & Inclusion

At Actalent, diversity and inclusion are a bridge towards the equity and success of our people. DE&I are embedded into our culture through:

• Hiring diverse talent
• Maintaining an inclusive environment through persistent self-reflection
• Building a culture of care, engagement, and recognition with clear outcomes
• Ensuring growth opportunities for our people

Actalent is an equal opportunity employer.

About Actalent

Actalent connects passion with purpose. We help visionary companies advance their engineering and science initiatives through access to specialized experts that drive scale, innovation, and speed to market. With a network of almost 30,000 engineering and sciences consultants and more than 4,500 clients across the U.S., Canada, Asia, and Europe, Actalent serves many of the Fortune 500. An operating company of Allegis Group, the global leader in talent solutions, Actalent launched as a new specialized engineering and sciences services and workforce solutions brand in 2021.