Quality Control Analyst

DescriptionExecute routine in-process, drug substance, and stability test methods.Use a variety of laboratory instrumentation and computer systems to collect and record data (such as LIMS, SoftmaxPro, Charles River Endoscan, MODA, and Empower).Maintain lab operations (including cleaning, ordering of supplies, reagent preparation, stocking, waste disposal).Demonstrate a functional understanding of a laboratory setting and Standard Operating Procedures (SOP's).Work within laboratory environment for extended periods of time, conducting facility monitoring (i.e., Environmental Monitoring and Critical Utility Monitoring) and product tests, reviewing data, maintaining laboratory materials and instruments and other laboratory functions as required.Complete all testing, including special project and protocol testing in a timely and appropriate manner.Maintain data integrity and ensure compliance with company SOP's, specifications, and cGMP regulations.Support low risk deviations, CAPA's and change controls within the electronic Quality Management System.Initiate and own laboratory investigations.Occasionally participate in department problem-solving.Author minor revisions to existing SOP's.Receives general instructions on routine work and detailed instructions on new assignments.May be required to work overtime or be assigned to a different shift as needed.May perform equipment maintenance and calibrations as required.Complete mandatory training within required timeframe.Perform other duties as assigned.QualificationsBachelor's or master's degree in any Life Sciences with relevant laboratory coursework.0-3 years of relevant experience.Previous experience in a regulated environment preferred.Laboratory instrumentation understanding or experience preferred.Must be able to communicate effectively with managers and peers.Must be able to read, write, and converse in English.Must have basic computer skills.General use of word processing, spreadsheets, databases, etc. for the purposes of work execution, training, performance management, and self-service.Good interpersonal skills and able to work effectively and efficiently in a team environment.Knowledge of cGMP manufacturing preferred.Knowledge of basic chemical, biological and/or microbiological safety procedures preferred.Must display eagerness to learn and continuously improve.QC Analytical Skill Set - HPLC, UPLC, UV-Vis, Appearance, Concentration, pH, CE, Osmolality, TOC, strong micropipetting skillsQC Bioassay Skill Set - ELISA's, Cell Maintenance, Cell-Based Assays, plate readers, Gels, icIEF, Aseptic Technique, strong micropipetting skills, biosafety cabinetsQC Micro Skill Set - Endotoxin, Bioburden, Environmental Monitoring, Manufacturing Cleanrooms, Aseptic Technique, Critical Utility systemsComplexity and Problem SolvingEmployee at this level is involved in routine tasks of basic scope and complexity.Employee receives detailed instructions on new work and refers to policies and procedures for guidance.Responsible for conducting independent work with guidance from trainers and more senior staff.Responsible for making basic decisions founded on sound principles, international industry/regulatory standards, and robust scientific basis.Understand the needs of key collaborators (i.e., Quality and Manufacturing Operations) to provide compliant and timely test results.Physical Demands:Must be able to remain in a stationary or standing position for extended periods of time in both office and laboratory environment.In certain areas of Quality Control, the following may apply:Carry weight, lifting - Frequently moves laboratory materials and portable instruments weighing up to 30 pounds.Climb - Occasionally ascends/descends step ladders to reach materials and/or stairs to collect samples.Dexterity/balance - required to gown for cleanroom work, balance and dexterity are required.BenefitsHealthcare 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.