QC Data Reviewer

A Medisca Partner, CED Analytical Labs is an analytics testing laboratory that delivers customized solutions with an unwavering commitment to quality and innovation that their customers can always count on. Offering worry-free and agile testing services at the highest standards of quality, CED Analytics supports partners in the pharmaceutical compounding, life-science, and healthcare industries. Committed to Partners in Wellness, CED Analytics offers an unfailing devotion to improving lives across a multitude of needs and multitude of people. The QC Data Reviewer will be responsible for the review of all laboratory data including routine QC testing and stability study testing. This position is responsible for ensuring that all documents are filled in accurately by the analysts and that all procedures are adhered to. The ability to analyze and interpret all forms of analytical chemistry data is required. The successful candidate will have a strong working knowledge of cGMP/GLP, USP/NF, EP, ICH, and FDA regulations. Responsibilities & Duties: Analytical Data Review and Release Perform data review on all types of analytical testing performed in the lab, including but not limited to, Identification testing, Wet Bench testing, Titration, HPLC, GC, ICP-MS, etc. using USP, EP, and manufacturer methods. Check all laboratory notebooks and associated print outs for correctness of raw data and verify all reagents, standards, and equipment used are within acceptable limits. Work with analysts to ensure timely document corrections and provide guidance on documentation requirements as needed. Notify Quality management of any out of specification results and provide support in the investigation process as needed. Ensure all data is reviewed quickly and accurately according to laboratory SOPs. Generate Certificates of Analysis for completed routine testing. Stability Perform data review on all types of analytical stability testing, including but not limited to, assays, chromatographic purity, water determination by Karl Fisher, etc. using USP, EP, and manufacturer methods. Notify Quality management of any out-of-trend or out of specification results as they relate to stability testing. Generate Certificates of Analysis and Interim Testing Reports for completed stability testing. Quality Operation Assist with internal facility and system audits on a regular basis. Support Quality management during external audits involving customers and regulatory agencies. Provide administrative support for sample login. Support other Quality Projects as needed. Qualifications: Bachelor of Science in Chemistry or a Science related field Minimum of three (3) years of experience in a pharmaceutical environment/cGMP laboratory Two (2) – three (3) years in Quality Control Experience with reviewing all forms of Analytical Chemistry Data Strong working knowledge of cGMP/GLP, USP/NF, ICH and FDA regulations Experience working with a Laboratory management system (LIMS) preferred, but not required. Knowledge of Microsoft Office suite (Word, Outlook, Teams and Excel) Excellent communication skills; fluent English (oral & written) required. Able to work independently and with minimal supervision. Strong organizational skills, ability to prioritize multiple projects, detail oriented. What’s in it for you… We invest time and resources into making sure CED is as good as the people we hire. Work/Life Balance – PTO, vacation policy and paid statutory holidays Invest in your health – Group Benefit plan and health savings account Your well-being is important – Wellness program offered Your Future is Bright – Opportunities to learn and grow within CED Save for your Future – CED contributes to a 401k plan when you invest in the plan Help us grow – Employee Referral Program We like to have fun – company events throughout the year We thank all applicants for their interest; however, only candidates to be interviewed will be contacted. We are an equal opportunity employer.