Qc Chemist Senior

Overview

Who we are? We are a French pharmaceutical industrial group, recognized for making affordable healthcare products that improve and simplify patients’ lives to as many people as possible. With 30 years of technological expertise, we position ourselves as a world leader in sterile single dose with 10 sites on 4 continents and more than 2000 employees. Since 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 300 employees.

Your role Reporting to the QC Supervisor - Finished Products
,

This position performs routine analyses as required. Performs method development and validation, from design to execution, with some supervision. Manages projects with moderate input. May independently manage the activities of others. Implements technical improvements to laboratories quality systems. Provides technical resources for laboratory and mentors less experienced employees as needed.

• Completed Analyses:
  Performs, interprets, evaluates, and records routine and some non-routine analytical lab tests of materials, drug substances and drug products following CGMPs (cGMPs).
• Execute protocols and experiments as written.
• Reviews and approves laboratory data.
• 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.
• Supports lab systems as assigned and maintains laboratory in compliance with SOPs, cGMPs, HS&E requirements, and FDA, DEA, USP, EP, and OSHA regulations.
• Develops and implements training to meet GMP, regulatory, and customer requirements and promotes first-time-right delivery.
• Monitors the effectiveness of training and adjusts approaches to ensure learning objectives are met.
• Identifies training needs and collaborates with Supervisor/Manager on solutions to performance issues.
• Assists in implementing new procedures by aiding in the design and delivery of training.
• Ensures documentation of training is retained as required by procedures.
• Performs method development and validation, from design to execution, with some supervision.
• Seeks opportunities to improve existing methods.
• Leads investigations, proposes solutions, and implements corrective action with minimal supervision.
• Conducts and writes laboratory investigations with minimal supervision; communicates issues and proposes/implements solutions.
• Recommends and assists in implementing improvements to lab procedures and processes.

• B.S. in Microbiology or Chemistry with minimum of three (3) years’ experience in an FDA-regulated laboratory OR
• B.S. in Life Sciences with five (5) years’ laboratory experience
• Ability to read, communicate and legibly write in English, analyze and interpret scientific and regulatory documents.
• Experienced in method development and validation.
• Competency in chromatographic techniques (HPLC, GC, chiral separation) and/or familiarity with spectroscopic techniques (MS, UV/Vis, FTIR), physical characterization and/or dissolution.
• Ability to evaluate data, perform trend analysis, identify issues, and implement solutions.
• Computer
  
  Skills:
  
  basic Outlook; advanced Word, Excel, PowerPoint with the ability to produce documents, charts, and tables; capable of creating complex documents and using basic data analysis tools.

• Scope of decision-making: complex analytical judgment; plan and perform duties with general knowledge of company policies; work independently toward general results; adapt procedures to meet different conditions.
• Level of supervision: project direction of other employees performing similar work.
• Contacts: regular internal contacts and occasional external contacts, including customers/clients.
• Physical requirements/environment: visual acuity, color recognition, finger dexterity;
  English literacy; exposure to chemical/biological hazards; sitting/standing ~50/50; lifting up to 35…