Quality Specialist II, Chemist

Position Summary

Performs a variety of chemical analyses and GMP review of raw materials, packaging components, ancillary solutions, in-process samples, finished product and stability samples in accordance with cGMP, GLP, DEA and company policies and procedures. Assists in writing and performing method validations and method transfers. Assists in process validations. Conducts equipment validations IQs, OQs, PQs, and MQs, if necessary. Provides assistance and technical support to other groups with chemical testing needs and performs troubleshooting of analytical methods and instrumentation.

• Perform all assigned testing in a timely and organized manner in accordance with cGMP, GLP, DEA and company policies and procedures.
• Accurately document all necessary and relevant information in a clear concise manner as per cGMPs.
• Operate and maintain all analytical instrumentation and equipment as per established procedures.
• Write, revise, develop and evaluate operational and maintenance procedures.
• Communicate openly within the group to provide and gather information, to optimize the use of resources and to optimize efficiency.
• Provide training and assistance to other group members.
• Actively participate in investigations, problem solving and troubleshooting.
• Ensure that equipment and working areas are maintained with good safety and housekeeping practices.
• Re-stock chemicals and consumables used in analysis.
• Prepare and present data summaries (written and oral) as necessary.
• Responsible for compliance with Controlled Substance documentation and accountability procedures and policies while maintaining high alert to diversion and theft possibilities.
• Exercises good judgment in interpreting, understanding context, and reporting data.
• Proactively identifies potential problems and recommend solutions.
• Prepares, writes, and distributes reports as appropriate.
• Participates in preparation and revision of job related controlled documents.
• Performs analytical testing of samples under limited direction.
• Skilled with laboratory equipment, including routine maintenance and calibration.
• Proficient with use and understanding of laboratory chromatography software.
• Performs other related assignments and duties as required and assigned.

The incumbent must have a BA or BS degree in Chemistry or closely related science in addition to 2 years minimum relevant experience. Graduate degree (MS Preferred) with one-year minimum experience.

Must demonstrate comprehension of at least two or more analytical technology (HPLC, GC, Dissolution, Automation, or Spectroscopy – UV/Vis, NIR, IR, or AA/AE); and should have a familiarity with cGMPs and FDA requirements. Relevant experience may include academic and/or industry experience and is measured based on the quality and quantity of the experience as it relates to the requirements of the position.

• All positions in the Quality Core Tract require the ability to:
  Fundamentally understand and use applicable quality systems.
• Maintain all accurate regulatory documentation.
• Collect data to ensure compliance with applicable GMP, GLP, GCP, GAMP (“GxP”) regulations and internal Standard Operating Procedures (“SOPs”).
• Maintain current knowledge base within relevant technical discipline of FDA regulations and awareness of the necessity and impact of compliance on the business.
• Maintain current knowledge base in relevant technical discipline.
• Each professional must possess effective interpersonal, verbal and listening skills.
• Knowledge of and adherence to appropriate laws and regulations are critical.

Perform job functions in various positions that may require sitting, stooping, balancing, kneeling, crouching, twisting, and/or reaching. While sitting for an extended period of time on a routine basis, incumbent may use the following equipment:
Personal computer, telephone/ other voice communication devices, copier, fax, scanners, or other specialized equipment used in an office setting. Lift and maneuver equipment and materials weighing up to 20 pounds. Take samples which may…