Quality Assurance Associate
The Quality Assurance associate is responsible for reviewing analytical data and ensuring that testing is completed according to appropriate analytical methods. This role must have a solid understanding of GMP requirements and follow New Jersey Laboratories Quality Manual, Standards Operation Procedures, and any applicable compendia methods. The ideal candidate will have experience in analytical laboratory procedures and methods as well as being familiar with quality systems.
Role and Responsibilities
- Ensure testing is conducted according to appropriate test methods and regulatory standards.
- Verify all calculations associated with analytical data.
- Verify that all equipment is calibrated and documented appropriately.
- Responsible for identifying and communicating errors found in documentation to analysts and management.
- Write and update Standard Operation Procedures, as required.
- Issuance and control of laboratory notebooks and documents.
- Assist in writing and reviewing deviations reports, as required.
- Ensure that stability study protocols are followed.
- Assist in maintaining and reviewing investigation reports.
- Work as a team: Departmental collaboration to achieve a common goal or to complete a task in the most effective and efficient manner
- To accommodate business needs, which includes understanding how to prioritize daily tasks and be efficient with managing time.
- Responsible for reviewing analytical data associated with but not limited to:
- High Performance Thin Liquid Chromatography
- High Performance Liquid Chromatography
- Gas Chromatography
- Inductively Coupled Plasma Mass Spectrometry
- Wet Chemistry Analyses
- Microbiological Analyses
The position includes all other responsibilities that may be necessary to fulfill the duties associated with the position or as may be assigned.
- Bachelor’s degree (or equivalent experience) in chemistry or biological science.
- Minimal two (2) years of experience in the pharmaceutical industry.
- Demonstrates a good understanding of United States Pharmacopeia testing procedures and methodology.
- Chemistry and biology knowledge.
- Experience in a cGMP environment.
- Excellent analytical, written, and verbal communication skills.
- Ability to work independently and collaborate on team projects.
- Computer competency with experience in Microsoft Office Suite.
- Authorized to work in the U.S. of America.
WORK CONDITIONS AND PHYSICAL REQUIREMENTS
The Quality Assurance and Regulatory Affairs Manager may require working additional hours to meet project deadlines and will travel occasionally to attend seminars, conferences, or trainings.
- Wear proper protective equipment.
- Sometimes exposed to loud sounds or distracting noise levels.
- Are often exposed to contaminants or hazardous conditions while conducting analyses.
- Work within several feet of others in the laboratory.
- Sit or stand for an extended period.
- Be able to lift objects up to 25 pounds.
- May have to crawl or climb to perform certain tasks like maintenance of an instrument.
- Repetitive tasks with few breaks.
Note: The Company will explore and provide reasonable accommodations to assist any qualified individual with a disability in performing the essential functions of his/her job.