QC Chemist

Quality Control AnalystSince 2013, our site Unither Manufacturing LLC. based in Rochester (NY), specializes in the manufacture of Blow-Fill-Seal, Liquid Stick-Packs, Pharmaceutical bottles, Tablets and Capsules. It has more than 360 employees.Reporting to the QC Supervisor - Finished ProductsJob SummaryThis position performs analyses of materials, drug substances and drug products following cGMPs. Supports method development activities and perform method validations with supervision. Maintains and proposes improvements to lab quality systems.Essential Functions / ResponsibilitiesCompleted Analysis Performs, interprets, evaluates, and records routine and some non-routine analytical lab tests of materials, drug substances and drug products following CGMPs.Execute protocols, experiments as written.Maintains instruments and equipment. Sets up instruments and conducts sample tests. Performs routine calibration of instrumentation. Ensures an adequate supply of test materials are available to perform daily testing.Maintains and updates training records in a timely manner.Methods & Validation Supports method development/validation and method transfer activities.Problems Identified & Resolved Proactively identifies issues, communicates & proposes/implements solutions.Performs laboratory troubleshooting; proposes solutions, implements with direction.Supports investigations, proposes solutions.Writes investigations with supervision.Recommends and assists in implementation of improvements to procedures.Safe, Compliant, Efficient Labs Supports lab systems as assigned and maintains laboratory in compliance with SOPs, cGMPs, HS&E requirements, and FDA, DEA, USP, EP, and OSHA regulations.Trainees Demonstrate the Ability to Execute Analytical Processes Implements training that ensures our ability to meet GMP, regulatory, and customer requirements and promotes first time right delivery.Monitors the effectiveness of their training efforts and modifies approach to ensure achievement of learning objectives.Distinguishes between training and non-training needs and works with Supervisor/Manager to recommend an appropriate solution to performance problems.May support/provide input for investigations, troubleshooting, and method development/validation with supervision. Writes basic investigations with supervision.We are committed to bringing these values to life with our employees by granting them a high degree of autonomy in the exercise of their profession and by encouraging their initiatives.We are committed to providing them with working conditions and atmosphere that is conducive to their development and the expression of their potential.Unither is an Equal Opportunity Employer. We are committed to providing reasonable accommodations for qualified individuals with disabilities and to ensuring equal employment opportunity for all applicants. Unifin SAS