Quality Control Analyst

Job Description Role is focus on daily laboratory operations and the execution of testing to support new product transfer and manufacturing activities. Testing may include samples from drug substance and drug product, manufacturing, stability, raw materials, and various protocol studies using approved test methods. Assays may include pH, visible particulates, osmolality, protein concentration, and qPCR. This position will also author and revise SOPs, review and approve protocols, as well as own document workflows in Veeva Vault. In addition, the role is responsible for maintaining operational readiness and GMP compliance within the QC areas. The position will also support more complex projects, operational excellence initiatives, and various quality systems. Follow specific, detailed instructions. Impact: Contributions are usually limited to task-related activities. Errors do not typically have major effect on the organization. Specific QC Focus Area: Biochemistry Focus: A280, SOLO A280, Compedia methods (pH. Moisture, OSMO, Appearance, Subvisible particles), Enzyme Activity assays, DNA, PCR, Free Thiol. 80% Testing execution. 10% QC operations support which entails data review, data trending, OE/5S initiative, maintenance of equipment and reagents, reagent prep, lab housekeeping, and support for other QC groups if needed. 10% Compliance and quality systems (SOP revisions, input to quality system). Requirements Bachelors degree and minimum of 2-4 years related experience. Desired: GMP knowledge, work experience. Limited use and/or application of basic principles, theories and concepts. Limited knowledge of industry practices and standards. Position requires critical thinking. Key Skills: MS Office, LIMS, SAP, Trackwise, Veeva Vault, EDMS, Compliance and strong science understanding. Complexity and Problem Solving: Solve routine problems of limited scope and complexity following established policies and procedures. Works on problems of limited scope. Follows standard practices and procedures in analyzing situations of data from which answers can be readily obtained. Builds stable working relationships internally. Contacts are primarily with immediate supervisors, and other personnel in the section or group. Repetitive bendings and reaching to set up and break down equipment. Ability to work around chemicals. Ability to wear personal protective equipment such as gloves, gowning, and respiratory protection in some cases. Ability to walk and stand for periods of time. 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 of the month following at least 1 calendar year after employment begins. Synectics is an equal opportunity employer. #J-18808-Ljbffr