Position Overview:
The QC Analyst II of analytical team will be responsible for testing of in-process, lot release and stability samples for various commercial and clinical drug products. Author and revise SOPs, deviations, CRs and LIRs. Areas of responsibility include but are not limited to testing samples for Appearance, pH, UV and water content, HPLC, ELISA, western blot and SDS-PAGE as needed. Participate or lead investigations, reports and process optimization activities as needed. Actively participate in group and project teamwork.
Job Duties:
Perform routine and non-routine release, in-process and stability testing for drug substance, drug product, and other critical reagents and documentation under cGMP.
Perform Analytical assays such as HPLC (SEC, IEX, HIC, RP, affinity), ELISA, SDS-PAGE, Western Blot, Water Content, UV, Appearance, and pH.
Independently author and lead quality records such as Deviations, Lab Investigations, CAPA, Change Control including leading thorough and timely investigation and/or implementation activities.
Author and revise SOPs as needed.
Lead and/or support method development, optimization, transfer, qualification, and validation activities of analytical methods.
Support equipment and software qualification and maintenance activities.
Review of laboratory records generated in support of QC testing including procedures, methods, audit trails and other controlled documents.
Provide training to laboratory analysts as needed and guide junior analysts in the lab environment including troubleshooting.
Work on multiple projects to meet departmental and organization goals.
Work collaboratively with Manufacturing, QA and Regulatory to support CMC analytical deliverables.
Experience Required:
B.S. in Science related field
3-4 years in a Quality Control laboratory environment (GMP environment) with a commercial setting.
Hands-on experience with a wide range of analytical techniques such as ELISA, SDS-PAGE, Western Blot, Karl Fisher and HPLC (SEC, IEX, HIC, RP, affinity).
Writing and or authoring deviations, lab investigations, protocols, SOPs, reports, and data trending.
Desired:
Prior experience working in method validations, method transfers, Raw material and stability testing is a plus.
Must be able to maintain data integrity, and understanding of US and international (e.g. EU, ICH, GXP) regulations.
Ability to manage multiple tasks and meet deadlines with a high tolerance for ambiguity, solutions oriented and able to problem solve and identify root cause.
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.