US ~ Boothwyn, PA
Quality Control Analyst
Our growing and successful business comprises of over 700 talented individuals globally, in an environment where everybody counts and is instrumental to our success. With state-of-the-art manufacturing and clinical facilities in the UK and USA, we deliver a full range of drug development solutions around the globe saving our clients both time and money.
People join Quotient Sciences because we are a respected member of the drug development world, specializing in delivering innovative solutions that integrate formulation development, real-time GMP manufacturing, and clinical testing. We pride ourselves on the quality of our services and our engaged culture. We are passionate about helping our customers get new medicines to market.
GENERAL PURPOSE OF JOB
The position may reside in any one of the functional areas and carry out the responsibility under some supervision:
- Analytical method validation and transfer activities.
- Formulation development work including Material characterization and physical testing
- API/raw material sampling and testing, In-process, finished product, and stability testing, cleaning verification swabbing and testing.
ESSENTIAL DUTIES AND RESPONSIBILITIES include the following. Other duties may be assigned.
Operate and troubleshoot the following instruments/equipment to test pharmaceutical samples:
- Dissolution apparatus
- Karl-Fisher water content titrator
- Other analytical instruments as directed
- Follow analytical test methods, compendial methods,experimental procedures and SOP’s
- Document test results in laboratory notebook, in real-time, and communicate status of test results to supervisor
- Peer review of laboratory notebooks for technical details
- Maintain control of all project related samples submitted to the laboratory
- Write and review methods, reports, etc.
- Perform housekeeping to assure the laboratory is continuously maintained in a safe and orderly condition
- Carry out duties in compliance with all state and federal regulations and guidelines including FDA, EPA, OSHA and DEA.Comply with all company and site policies and procedures
- Manageresponsibilities and work in an efficient manner to assure accurate and timely data reports
- Consult and work closely with supervisor regarding any issues with sample preparation, instrument performance, data acquisition and analysis as it applies to data integrity and accuracy
- Train on all the SOPs and company procedures on regular basis and remain up to date with the training curriculum
ADDITIONAL POSITION REQUIREMENTS
- Remain current in profession and industry trends
- Make a positive contribution as demonstrated by making suggestions for improvement
- Learn new skills, procedures and processes including aspects of formulation development
- Is available for other duties as required
- Is available for overtime as needed
EDUCATION and/or EXPERIENCE:
Requires B.S. in Chemistry or equivalent with a minimum of 2-5 years or M.S or Ph.D in Chemistry or equivalent with a minimum of 0-2 year of industrial pharmaceutical laboratory experience or a combination of equivalent training, experience and education. Knowledge of experiment documentation, operation and basic troubleshooting of analytical instrumentation and knowledge of GMP, GLP, and ICH guidelines.
- Read and interpret documents such as safety rules, operating and maintenance instructions, manuals, and standard operating procedures.
- Work with mathematical concepts such as mean, standard deviation and relative standard deviation
- Apply concepts such as fractions, percentages, ratios and proportions to practical solutions
- Identify problems, collect data, and establish facts
OTHER SKILLS, ABILITIES OR QUALIFICATIONS
- Knowledge of chemical concepts and theories
- Familiar with a variety of laboratory equipment and data acquisition
- Excellent written/oral communication skills,
- Computer knowledge (excel, word)
- GMP regulationsAbility to work independently as well as with others in a team environment