Quality Control Analyst

Description

• Independently execute and review routine in-process, drug substance, and stability test methods in a timely manner.
• 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).
• Conduct test methods including samples generated for facility monitoring (i.e., Environmental Monitoring and Critical Utilities), in-process, drug substance, and stability.
• Own and author quality system events (i.e., laboratory investigations, deviations, CAPA's and change controls).
• Demonstrate a functional and basic theoretical understanding of laboratory operations 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.
• Independently exercise judgment within generally defined Quality Control (QC) procedures and practices in selecting methods and techniques to troubleshoot problems and/or formulate solutions.
• Decisions have moderate impact on future QC processes and procedures that impact batch disposition.
• Initiate and own laboratory investigations, basic complexity low and medium risk deviations, CAPA's, and change controls of moderate scope within the electronic Quality Management System.
• Participate in cross-functional teams.
• Draft studies and investigations of moderate scope and work on problems where the situation or data requires a review of identifiable factors.
• Author new SOP's and initiate changes to existing procedures.
• Train new QC Analysts on routine procedures and practices.
• May be required to work overtime or be assigned to a different shift as needed.
• Perform equipment maintenance and calibrations as required.
• Complete mandatory training within required timeframe.
• Participate in cross-functional collaboration with internal departments (i.e., Quality, Manufacturing, Engineering, Metrology, and Business Excellence).
• Responsible for conducting independent work with minimal guidance from trainers and more senior staff.
• Responsible for contributing to moderate scope decisions founded on sound principles, international industry/regulatory standards, and robust scientific basis.
• Understand the needs of key collaborators (i.e., Manufacturing Operations, Quality Assurance, Validation and Quality Systems) to provide compliant and timely test results.
• Must be able to remain in a stationary or standing position for extended periods of time in both office and laboratory environment.
• 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.
• May be required to wear personal protective equipment (PPE) and other clean room garments daily. This may include safety shoes, safety glasses, aprons, face shields, lab coats, full body gowns, hair nets and gloves and hearing protection.
• May be required to participate in an on-call rotation for off-shift coverage or occasionally work off-shift hours to help support a 24-7 manufacturing department.
• Willingness to travel to various meetings or training, this could include overnight trips.
  
  

Requirements

• Bachelor's or Master's degree in any Life Sciences with relevant laboratory coursework
• 3-6 years of relevant experience preferred.
• Previous experience in a regulated environment preferred.
• Must understand laboratory instrumentation.
• 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
• Knowledge of chemical, biological and/or microbiological safety procedures.
• Must display eagerness to learn and continuously improve.
• QC Micro Skill Set - Contamination control, Endotoxin, Bioburden, Environmental Monitoring, Manufactuirng Cleanrooms, Aseptic Technique, Critical Utility systems
  
  

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.