Conduct testing of raw materials, in-process materials, and formulation samples in support of production at the *** Johns Creek Manufacturing site.
Responsible for the inspection and disposition of raw materials, packaging components, and parts in support of production at the *** Johns Creek Manufacturing site.
Perform tasks according to approved SOP's, methods, and procedures in compliance with cGMP, FDA regulations and Corporate Quality Policies.
Maintain QC Analytical Laboratory in compliance with regulatory standards and site procedures.
Document and Review Analytical Data and Laboratory records accurately, completely, and in a timely manner.
Conduct lab investigations and special analytical projects, as assigned.
Complete and participate in training activities, as assigned, and to perform job responsibilities and maintain up to date analytical skill sets and practices.
Participate in continuous improvement activities looking to pursue laboratory best practice and offer appropriate feedback when non-value added activities are observed.
Computer Skills with working knowledge of MS Office Suite (Outlook, Word, and Excel).
Excellent written and verbal communication and interpersonal skills.
Excellent problem solving skills including experience independently writing technical investigations that include a root cause and corrective action, i.e. nonconformance reports and corrective action reports.
Preferred: Experience with LabVantage or similar LIMS, Empower3 or similar data acquisition systems.
Up to 2 years of experience working within a cGMP compliant industry. Demonstrated ability to work on and solve routine analytical problems. Working knowledge of USP, HPLC, GC, UV/Vis, FTIR, Particle Size Analysis, and other common laboratory techniques. Familiarity with computer applications and data acquisition systems. LIMS experience, preferred. Experience with Chromatography instruments.