Assistant QC Scientist

6 days ago

Warren, United States Synectics Inc Full time
Job DescriptionJob Description

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.

  • Additionally, when needed, this position will be able to assist with training and assay transfer.

  • 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.

  • Able to distinguish colors and possess correctable vision to 20/20, annual eye exam is required.

  • Analyze numerical values on a daily basis.

  • Working a laboratory setting up to six (6) hours per day.

  • Working around biohazardous materials, including chemical agents, up to six (6) hours per day.

  • Position Handles Hazardous Materials

Qualifications:

  • Bachelor's degree required, preferably in Science.

  • Will accept Master's degree with less experience (1-2 years)

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

  • 2+ years of hands-on experience with bioanalytical technique such as ELISA, Potency, Cell based assays, etc.

  • 1+ Experience working in regulated environment (e.g. cGMP, cGLP)

  • Previous Assay Transfer, assay validation experience

  • Previous CAR-T experience preferred

  • Technical understanding and troubleshooting skills

  • Experience/knowledge in deviation, CAPA, Change Control

  • Team player, flexible, good communication skills

  • 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.

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.

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