Location
Wilson, NC | United States
Job description
Job 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.
Primary Responsibilities
- 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.
Education and Experience Requirements
The incumbent must have a BA or BS degree in Chemistry or closely related science in addition to 2 or more years of minimum relevant experience. Graduate degree (MS Preferred) with one-year minimum experience.
Necessary Knowledge, Skills, and Abilities
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.
COMMON ACCOUTABILITIES AND SKILLS:
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.
Supervisory Responsibilities (if Applicable)
There are no positions reporting to this position.
Physical and Environmental
- 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 require stretching, bending, or twisting to remove product from the equipment and/or drums.
- Use small hand and power tools to perform incidental maintenance.
- Perform cleaning and assembly/disassembly on laboratory equipment which may require pulling, pushing, or twisting to remove equipment shields, parts and panels. Equipment and parts could weigh up to 20 pounds. Also requires operation of industrial hose (water) and physical exertion (repetitive wiping, rubbing and scrubbing) to clean equipment and laboratory surfaces.
- Ability to work a 10 hour per day/4-day work week; 40 hours per week with overtime as required.
Additional Information
The job description is not an exhaustive list of all functions that the employee may be required to perform, and the employee may be required to perform additional functions. Additionally, the company may revise the job description at any time.
Job tags
Salary
