QC Associate - Environmental Monitoring in Hanover, NJ at Apex Life Sciences

Date Posted: 9/26/2018

Job Snapshot

Job Description

QC Associate - Environmental Monitoring

Purpose and Scope of Position

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 transfer.

Knowledge, Skills, and Abilities

  • Familiarity with various microbiology techniques and environmental monitoring.
  • Ability to accurately and completely understand, follow, interpret and apply Global Regulatory and cGMP requirements.
  • Ability to assist with Technical writing and data trending if needed.
  • 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 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 equipment.
  • 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.
  • Minimum 2+ years of relevant work experience, preferable in a regulated environment.
  • An equivalent combination of education and experience may substitute.
  • Experience working in clean room environments and with cell therapy products is strongly preferred.

Working Conditions

  • The incumbent must analyze numerical values on a daily basis.
  • The incumbent will be working a laboratory setting up to seven (7) hours per day.
  • The incumbent will be working around biohazardous materials, including chemical agents, up to seven (7) hours per day.
  • Flexible scheduling required

FOR IMMEDIATE CONSIDERATION please email your resume to grucci@apexlifesciences.com or call 732-874-7133


EEO Employer

Apex is an Equal Employment Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, age, sexual orientation, gender identity, national origin, disability, protected veteran status, or any other characteristic protected by law. Apex will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable law. If you have visited our website in search of information on employment opportunities or to apply for a position, and you require an accommodation in using our website for a search or application, please contact our Employee Services Department at 844-463-6178.