Piramal Enterprises Ltd.
POSITION SUMMARY: The Quality Control Scientist is responsible for providing analytical chemistry support for the facility.
To perform this position successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill and/or ability required.
Shall adhere to all regulatory requirements, including FDA, EPA, OSHA, and related safety, health and environmental procedures, policies and practices.
Consistent support and practice of all Ash Stevens/Piramal’s mission and values.
Support manufacturing operations with testing of raw materials, starting materials, intermediate products, final products, and cleaning verification samples. Sample “Quarantined\ materials upon receipt.
Testing of reference standards and stability samples.
Document sample preparation, equipment set-up, and test results in laboratory notebooks or other appropriate test record forms. Verify data with second quality team member as required. Maintain all records as required to maintain compliance.
Assist in the preparation of new or revised documentation as required.
Participate in quality unit projects, including but not limited to supplier certification, methods development, methods validation and training of both quality unit members as appropriate.
Provide support in maintenance and calibration of laboratory analytical instrumentation. Perform routine calibration verification of facility instrumentation such as balances and thermometers. Maintain accurate records regarding maintenance and calibration activities. Interact with Mettler-Toledo representative as appropriate (scheduling for service repairs and calibrations).
Assist in the maintenance of the QC laboratory. In addition to routine housekeeping and glassware cleaning, maintains appropriate inventory of supplies and chemicals. Keeps work area organized.
As required, performs routine testing on the water system (DI, ice, potable, and QC water) and prepared reports as needed
Bachelor’s degree in Chemistry or BioChemistry
Minimum two (2) to five (5) years of experience in pharmaceutical quality control
Knowledge of analytical testing and instrumentation
Excellent organizational and planning skills.
Strong written, verbal, and interpersonal communication skills.
High attention to detail.
Demonstrated strong analytical skills, and the ability to work independently against multiple deadlines.
Physical demands and work environment:
The physical demands and work environment described here are representative of those that must be met by a team member to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
Frequent lifting, bending, stooping, squatting, pushing and pulling can be expected.
Long periods of sitting and walking may also be expected in this position.
This position may require long periods of sitting, typing, computer entry or looking at a computer.
Potential limited exposure to hazardous chemicals.
Personal protective equipment including safety glasses, lab coats, gloves, specialized clothing including laboratory uniform and appropriate shoes may be required in areas associated with this position
Piramal Enterprises Ltd.