Easter Seals Jobs

Purpose:

The QC Analyst is responsible for supporting Quality Control bioanalytical testing for release of clinical and commercial products. This includes the ability to interface with multiple groups, the ability to independently perform tasks, interpret results, and troubleshoot. Additionally, when needed, this position will be able to assist with training and assay transfer.

Required Competencies: Knowledge, Skills, and Abilities

• Hands-on experience with various bioanalytical techniques including ELISA, qPCR and FACS and cell-based assays.

• Experience in assay transfer, technology transfer, validation from Analytical Developmental group to Quality Control group.

• Ability to accurately and completely understand, follow, interpret and apply Global Regulatory and cGMP requirements.

• Technical writing skills.

• Problem-solving ability/mentality, technically adept and logical.

• Ability to represent the interests of the group on cross-functional teams.

• Ability to set priorities of the group and manage timelines.

• Ability to work with management locally and globally.

• Ability to communicate effectively with peers, department management and cross-functional peers.

Duties and Responsibilities

• Perform testing of in-process, final product, stability samples, and method transfer.

• Utilize scientific principles to assist in analytical testing methods and the proper use of laboratory equipment.

• Anticipate and troubleshoot problems.

• Recommend corrective actions and participate in the development of best practices.

• Understanding of regulatory guidelines.

• Complete all work in a timely manner.

• Work and communicate effectively within the team to ensure timelines are met.

• Apply technical knowledge and abilities to ensure all testing is performed in a compliant manner.

• Communicate effectively with peers, and demonstrate teamwork, with regards to results of review and corrections required.

• Document training per procedural and cGMP requirements.

• Perform assigned tasks within a CAPA, deviation, or project

• Draft and review technical documents, such as SOPs and forms.

• Communicate effectively with management regarding task completion, roadblocks, and needs.

• Performs other tasks as assigned.

Education and Experience

• Bachelor’s degree required, preferably in Science.

• 2-3 years of relevant work experience, preferably in a regulated environment.

• An equivalent combination of education and experience may substitute. EX: if the person has a Master degree but less exp. (1-2 years), manager would still consider that candidate.

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 (%20actalentaccommodation@actalentservices.com) for other accommodation options.