Associate Specialist, Quality Control

Job Description

Are you driven by the desire to make a significant impact on global health? Join our company, a leading research-intensive biopharmaceutical organization. We are pioneers in developing innovative health solutions that advance the prevention and treatment of diseases in both humans and animals. As an Associate Specialist in Lab Technical Operations, you will be an integral part of our manufacturing division, contributing to our mission of saving and improving lives around the world.

Responsibilities:

• Execute sample management efforts across large molecule areas. This includes the movement of sample and reagent materials on site, domestically, and internationally.  

• Operate and contribute to the various sample inventory systems on site (RLIMS, Bioinventory, etc.)

• Perform sample manipulation and coordination with the supply chain and external laboratories as required (e.g. formulation, dispensing, aliquoting, labelling, etc.)

• Support vaccine and biologic manufacturing processes as part of a cross-functional team.

• Learn new processes and procedures.

• Maintain well-documented, organized and up-to-date study files with respect to sample paperwork/inventories.

• Write, review, and improve Standard Operating Procedures for the operation of equipment and processes.

• Contribute to process and equipment safety reviews.

• Perform second scientist/second person review as required.

• Ensure all work is compliant with regulatory expectations and conforms to current Good Manufacturing Practices (cGMP) and EHS guidelines.

• Ensure adherence to all current regulatory data integrity (ALCOA) requirements.

• Submit audit responses for approval and provide assistance with laboratory audit preparation activities where required.

• Conduct technical/operational investigations and analyses and recommend corrective and preventative actions.

• Generate and track metrics associated with material aliquot and sample storage/movement

• Support other departments to win as one team.

• Embrace and establish an empowered, diverse, and inclusive team culture.

Education Requirements:

• Bachelor’s degree or higher in engineering, science, or business fields.

Required Experience and Skills:

• 1-4 years of Bioanalytical or sample management experience.

• Proficiency with Microsoft Office applications (Word, Excel, PowerPoint).

• Knowledge of laboratory operations.

• Ability to perform technical procedures.

• Understanding of Good Laboratory Practices (GLPs) with GMP control environment.

• Schedule Flexibility.

Preferred Experience and Skills

• Strong personal motivation to work for a company that saves and improves lives.

• Interest in a diverse career at an active, dynamic manufacturing campus.

• Strong motivation to succeed and to help others to do the same.

• Excellent attention to detail.

• Ability to prioritize and manage time.

• Strong critical thinking skills and a proactive, hands-on approach to problem-solving.

• Ability to examine an issue from diverse perspectives (safety, compliance, maintenance, automation, equipment, process, and people) in order to best understand and resolve it.

• Enthusiastic and confident self-starter, with a passion for continuous learning.

• Strong communication skills, written and verbal.

• Works independently and as a team member with integrity, precision, motivation, respect, and inclusion. #EBRG'S #VetJobs

Required Skills:

Accountability, Accountability, Aseptic Manufacturing, Biopharmaceuticals, Communication,