Quality Control Validation Scientist

About the role

As a QC Analytical Scientist, you will support various Quality Control activities within the AQC department. You will transfer and execute analytical methods, including raw materials, for use in a cGMP environment in Quality Control, covering both analytical quality control methods (AQC) and Quality Control Microbiology methods (QCM).

Responsibilities

• Drive analytical method validation and transfer of laboratory methodologies.
• Support the execution, issue resolution (e.g., discrepancies), and completion approval of test plans/protocols.
• Support troubleshooting of analytical methods.
• Ensure laboratory equipment is maintained in a validated state and that all analytical methods transferred follow company and regulatory requirements.
• Responsible for protocol and report generation and other technical documents as required, including supporting raw material qualification for new products.
• Use sound scientific principles and statistical techniques to solve problems and make recommendations.
• May support the installation, operational qualification (IOQ), maintenance, and troubleshooting of instrumentation in the AQC group.
• Responsible for deliverables to ensure timelines and milestones are met.
• May need to work in controlled or clean room environments requiring special gowning.
• May work around chemicals such as alcohol, acids, and buffers that may require respiratory protection.
• Able to work more than 8 hours a day or 40 hours a work week as needed.

Requirements

• Bachelor's Degree in Biotechnology, Microbiology, Pharmacy, Chemistry, or equivalent.
• Minimum of 1 year of analytical development or validation experience in Pharmaceutical, Biopharmaceutical, or related manufacturing environment, or an advanced degree.
• Strong technical writing skills and ability to generate technical documents and reports that meet company and regulatory requirements.
• Knowledge of analytical methods and operations with a strong emphasis on problem-solving.
• Knowledge of analytical method validation.
• Intermediate statistical knowledge and experience with data analysis.
• Knowledge of cGMP, especially lab-related topics such as method validation and unexpected results investigation.
• Basic knowledge of regulatory requirements concerning analytical instrumentation and test methods.
• Substantial knowledge and understanding of regulatory standards requirements (e.g., CGMP, QSR, USP, 21CFR, ICH).
• Ability to complete tasks with minimal direction and demonstrate basic project management skills.
• Ability to multi-task in a highly dynamic and diverse environment.
• Attention to detail, good organization, and time management skills to meet deadlines.
• Proficient in Microsoft Office.
• Strategically and business-oriented thinking.

Nice to have

• Experience with the KNEAT Program.
• Experienced in reviewing and approving Life Cycle Validation Documents.
• Familiarity with paperless validation software for life sciences.
• Experience with Commissioning, Installation, Operational, and Performance Qualification protocols and reports for Equipment, Facilities & Utilities at Biopharmaceutical Manufacturing plants.
• Experience with Computer System Validation protocols and reports, including SCADA and MES.
• Experience with QC/Micro Laboratory Instrument Qualification and method validation.

Benefits

• Healthcare Insurance: Eligible employees and their dependents receive 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. Premiums are subsidized by Synectics.
• Dental Insurance: Eligible employees and their dependents receive a dental plan through MetLife. Eligibility begins on the 1st day of the calendar month following 60 days of continuous full-time employment.
• Vision Insurance: Eligible employees receive vision insurance through VSP. Eligibility begins on the 1st day of the calendar month following 60 days of continuous full-time employment.
• 401(k) 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.