QC Analyst

Job Description

• 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.
• Asist with training and assay transfer.
• Perform testing of in-process, final product, and stability samples.
• 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 and can independently develop, write and execute methods, protocols, reports and other related documents.
• Complete all work in a timely manner.
• Work and communicate effectively within the team to ensure timelines are met.
• 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.
• Perform training effectively.
• 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
• Draft and review 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.
  
  

Qualifications

• Bachelor's degree required (preferable in Science)
• 2-4 years of relevant work experience, preferably in a regulated environment.
• An equivalent combination of education and experience may substitute
• 2 years of relevant analytical testing or QC experience or equivalent combination of education and experience, preferably in a regulated environment.
• 2 years of experience in cell and molecular biology techniques (e.g., cell-based assays, flow cytometry, qPCR, ELISA, Tissue Culture).
• 2 years of experience in writing technical documents.
• 3 years of Microsoft Office
• Hands-on experience with various bioanalytical techniques including ELISA, qPCR and FACS.
• 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.
• The incumbent should be able to distinguish colors and possess correctable vision to 20/20, annual eye exam is required.
• The incumbent must analyze numerical values on a daily basis.
• The incumbent will be working a laboratory setting up to six (6) hours per day.
• The incumbent will be working around biohazardous materials, including chemical agents, up to six (6) hours per day.
  
  

Benefits

Healthcare Insurance: Synectics offers eligible employees and their dependents healthcare coverage through BlueCross BlueShield of Illinois. Eligibility begins on the 1st day of the calendar month following 60 days of continuous full time employment with Synectics. Premiums are subsidized by Synectics.

Dental Insurance: Synectics offers eligible employees and their dependents a dental plan through MetLife. Eligibility begins on the 1st day of the calendar month following 60 days of continuous full time employment with Synectics.

Vision Insurance: Synectics offers eligible employees vision insurance through VSP. Eligibility begins on the 1st day of the calendar month following 60 days of continuous full time employment with Synectics.401(k) Plan: The Synectics Inc. Investment Savings Retirement Plan. Synectics offers all employees who are 21 years of age or older the opportunity to invest in the 401(k) Plan on the first enrollment date that is at least 30 days after employment begins. Enrollment dates are each January 1st, April 1st, July 1st, and October 1st.

Technical Certification Bonus: Synectics is pleased to award its employees a bonus of up to $500 for an approved professional certification. In determining the bonus amount, Synectics will consider the cost of the test(s) for any certification relating to your current position, achieved during your employment with us. Only one Certification Bonus per calendar year may be awarded per employee. Only current, active employees will be eligible to receive this bonus. It will be awarded 90 days after the Synectics office has received documentation confirming the successful completion of the certification.

Synectics is an equal opportunity employer.