Scientist

Description:

The Scientist I will be working under the supervision of the

Pharma QC Lab Supervisor and will be responsible for non-routine method

development and validation, routine analysis and testing, equipment calibration

and maintenance, and routine product release sample analysis and stability

analysis. They will also be required to be able to troubleshoot complex

equipment issues, multi-task, and follow SOP's.

• Performs development and analytical validation/verification

activities per USP and ICH criteria.

• Ability to validate HPLC, GC and dissolution methods and

generate appropriate and accurate protocols and reports.

• New equipment validation

• Follows in-house procedures to complete testing.

• Suggests possible improvements to current testing.

• Organizes and prioritizes testing workload to achieve goals

and objectives.

• Verify like work performed by other analysts.

• Prepares documents suitable for FDA (Federal Drug

Administration) submissions.

• Conducts routine OOT/OOS investigations to determine root

cause.

• Performs trending activity to aid in investigations.

• Updates/Revises SOPs to comply with current standards.

• Performs routine equipment calibrations as specified by SOP.

• Performs routine laboratory maintenance as specified by SOP.

• Routinely maintains a clean work area.

• Other duties as assigned.

Skills:

Chemistry, HPLC, GC, LC, Method Development, Equipment

validation, SOP, analytical chemistry, Dissolution

Additional Skills & Qualifications:

• Bachelor's degree in Chemistry, Biochemistry or other related

scientific field.

• Extensive experience with equipment validation and method

development.

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

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.

If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please email actalentaccommodation@actalentservices.com for other accommodation options.