QA Specialist 2 at PCI Pharma Services in Rockford, IL

Summary: PCI Pharma Services is a company focused on life-changing therapies and making a global impact. They are seeking a QA Specialist 2 to ensure compliance with quality assurance standards and regulatory requirements through the review of pharmaceutical materials and testing processes. Responsibilities: - Timely and efficient review ensuring a high level of accuracy with minimal personal error, completeness and compliance to requirements to ensure that Quality Assurance standards and regulatory requirements are met, including data integrity - Record and maintain all related data and records in compliance with cGMP and ALCOA principles - Knowledge of USP/EP general chapters and ICH guidelines which pertain to job function - Train other associates in data review for which expertise/competency has been demonstrated - On time completion of assigned training in ComplianceWire - Participate in internal Health and Safety audits including developing actions and follow up - Participates in internal, customer and regulatory audits - Maintains a high level of safety and highlights any potential unsafe act immediately to all and works with relevant personnel to prevent further occurrence - Participates in implementation and execution of continuous improvement activities - Play a role in creating and maintaining an atmosphere of teamwork throughout the laboratory - Knowledge of and adhere to all PCI, cGMP, and GCP policies, procedures, rules - Embodies cultural values and aligns daily actions with department goals and company culture - This position may require overtime and/or weekend work - Performs other duties as assigned by Laboratory Management - Performs review of microbial testing and analytical chemistry testing related to QC functional responsibilities - Supports Commerical and Clinical stability and release by performing review of analytical testing of raw materials and drug products for the following tests in accordance with GMP, GLP and company test methods: - Issue notebooks, worksheets and test forms in accordance with defined procedure - Plans and organizes work with periodic supervision and communicates data review progress to Laboratory Management as needed - Ability to interpret different customer method requirements with minimal supervision - Actively participates in and method transfer and/or method validation activities between facilities within the organization or between organizations by reviewing method transfer protocols and reports for any of the above analytical testing listed - Technical Data Review of New/Revised Test Methods/SOP’s/Work Practices - Authors deviation investigations, Out of Specification investigations, Out of Trend investigations, develops Corrective Actions/Preventative Actions as needed - Reviews data using statistical tools such as Chromatography Data System (Chromeleon) and Microsoft Excel - Gathers data for APR’s and authors APR reports for various customers - Drives on time completion of data correction activities in conjunction with the QA Supervisor - Associate should be self-motivated, organized, capable of working independently and in a collaborative environment - Ability to prioritize and multi-task concurrent project demands, while maintaining exceptional attention to detail as well Required Qualifications: - Bachelor's Degree in a related field and/or 1-5 years of related experience and/or training - College-Level Mathematical Skills - Intermediate Computer Skills: Ability to perform more complex computer tasks and knowledge of various computer programs - Full Professional Proficiency: Ability to speak, read, and write fluently and accurately on all levels pertinent to professional needs - Very High Reasoning: Ability to define problems, collect data, establish facts, and draw valid conclusions. Be able to interpret an extensive variety of technical instructions in math or diagram form and deal with several abstract/concrete variables - High Standard of Report Writing Preferred Qualifications: - Ability to demonstrate attention to detail - Ability to adapt to a changing work environment - Ability to hold oneself in a professional manner - Ability to identify and resolve problems in a timely manner - Ability to exhibit sound and accurate judgment - Ability to demonstrate excellent time management skills - The ability to display a willingness to make decisions - Ability to take ownership of issues and work towards resolution - Ability to work to ensure good interpersonal relations are maintained Required Skills: HPLC, GC, Pharmaceutical testing Important Skills: Statistical tools, cGMP knowledge, Report writing Nice-to-Have Skills: Interpersonal relations, Attention to detail, Time management, Problem solving, Adaptability Benefits: Paid time off, Health insurance coverage (including dental and vision), Flexible spending account, 401(k)