Contractor, QC Associate, Environmental Monitoring

Exciting opportunity to work in our state-of-the-art facility located in Florham Park, NJ.  The QC Associate is responsible for supporting Quality Control microbiology testing for release of clinical and commercial products and environmental monitoring. 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 development/implementation.

Perform environmental monitoring and testing of in-process, final product, and stability samples.

• Utilize scientific principles to assist in microbiological testing methods and the proper use of laboratory
• Assist with assay and equipment troubleshooting.
• Participate in continuous improvement projects.
• Willingness to learn regulatory guidelines and assist with developing, writing and executing methods, protocols, reports and other related documents.
• Complete all work in a timely manner without constant supervision.
• Work and communicate effectively within the team to ensure timelines are met.

Participate in visual inspection of cell therapy and human tissue products.

• Contribute to development or modifications of visual inspection paradigm.
• Execute visual inspection process within specified timelines.

Perform peer review of testing data.

• Review all data in accordance with applicable procedures and cGMP requirements.
• Apply technical knowledge and abilities to ensure all testing is performed in a compliant manner.
• Complete all review in accordance with required release timelines.
• Communicate effectively with peers, and demonstrate teamwork, with regards to results of
• review and corrections required.

 Train new analysts to general job duties.

• Complete necessary training to become a qualified trainer.
• Assist in training new analysts
• Document training per procedural and cGMP requirements.

Support document revision, project, CAPA, and investigation/deviation related tasks.

• Perform assigned tasks within a CAPA, deviation, or project
• Assist in drafting and review of technical documents, such as SOPs and protocols/reports.
• Communicate effectively with management regarding task completion, roadblocks, and needs.
• Demonstrate initiative, courage, and continuous improvement throughout investigation/corrective action lifecycles

Performs other tasks as assigned.

Education and Experience

• Bachelor’s degree in a scientific discipline required, ideally a microbiology background.
• 0-2 years of relevant work experience
• An equivalent combination of education and experience may substitute.
• Experience working in clean room environments and with cell therapy products is a plus

Working Conditions

• The incumbent will be working in a GMP Cleanroom/laboratory setting daily throughout the day.
• The incumbent must evaluate numerical values
• The incumbent will be working around potentially biohazardous
• Must be able to lift up to 25 lbs. on a daily routine basis
• Flexible scheduling required

This job description is intended to describe the general nature and level of work being performed by the person assigned to this position. The primary duties and responsibilities are intended to describe those functions that are essential to the performance of this job.

This job description does not state or imply that the above are the only duties and responsibilities assigned to this position. There are other duties and responsibilities that are considered incidental or secondary to the overall purpose of this job. Employees/contractors holding this position will be required to perform any other job-related duties as requested by management.