AddressDescription
Description:
• Execute feasibility (pre-validation) studies to support validation experimental design
• Translate technical information and requirements into experimental design
• Generate, review and execute phrase appropriate method
validation/verification/transfer protocols
• Prepare documentation in support of the sampling, analysis, and reporting of method
qualification or validation results
• Perform troubleshooting during method qualification or validation.
• Perform data analysis, interpretation and review using statistical methods
• Prepare summaries and reports
• Compile and track undesirable/unacceptable problems encountered during analytical
method execution
• Write, review and assist in the evaluation of the effectiveness of SOPs and identify
necessary changes following validation activities. Ensures that SOPs are current
• Assist in the maintenance of validation/verification/transfer documents
• Assist to write risk analysis (or statistical analysis) as part of validation activities;
• Monitoring and tracking of validation/verification/transfer activities
• May assist with training, competency assessment, and performance evaluations of
laboratory personnel as appropriate
• Investigate deviations in validation protocols, identify the root cause of the deviation,
issue corrective and preventive actions, and carry out follow-up once the actions are
implemented to ensure their effectiveness;
• Work closely with AD to ensure accurate transfer of methods from AD to QC.
• Work closely with QC to ensure accurate scheduling of instrumentation and validation
activities
• Work closely with QA to ensure documents are reviewed and approved in a timely
manner
• Work closely with Project Management and the Account Manager to ensure that
customer expectations with respect to method validation and transfers are met
• Work closely with Regulatory Department to ensure that information is pertinent to
method validation are transparent to regulatory
• Offer expertise to other departments of the company such as Production, Maintenance,
Quality, Engineering and Analytical Services;
• Plan and coordinate the activities required as part of the validation protocol with the
departments of Production, Maintenance, Quality, Engineering and Stability;
• Responsible for continuous evaluation/ optimization of test methods for efficiency and
cost reduction
• Perform other duties as assigned
Additional Skills & Qualifications:
• BS or MS in Analytical Chemistry or equivalent
• 2+ years experience in a cGMP pharmaceutical/biotechnology laboratory
• Strong technical knowledge HPLC, GC and MS
• Proficient use of Microsoft Office suite of applications (Outlook, Excel, Word, PowerPoint,
Teams, etc.)
• Ability to work as part of a team and also independently with minimal to no supervision
• Ability to rapidly change focus during times of shifting or changing priorities
• Impeccable technical writing skills with extreme attention to detail, specifically the lexicology
and grammatology of written English text as applied to technical writing
• Excellent organizational, multitasking, and communication skills
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
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
The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.
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