JOB SUMMARY:
The essential job function is to oversee development and validation of analytical methods for raw materials, work-in-process, and finished products.
Aptalis is an Equal Opportunity Employer “EEO/M/F/DV”.
ESSENTIAL DUTIES AND RESPONSIBILITIES:
The essential job function is to oversee development and validation of analytical methods for raw materials, work-in-process, and finished products.
Collect and compile necessary literature to support the development process; utilizing all necessary information available from publications such as USP, NF, BP, JEP, Florey, etc.
Record all work and data in the approved laboratory notebooks.
Comply with all regulations as specified by OSHA, EPA, FDA, etc., and as defined in Corporate Hygiene plan.
Prepare and/or revise technical reports and other documents.
Ensure all necessary equipment, supplies and reagents are ordered in advance of need.
Assist in transferring analytical procedures to Quality Control.
Train other analytical chemists and technicians.
Stay abreast of government regulations and assure that other chemists are trained and informed on all aspects of regulations.
Maintain laboratory equipment and perform analytical troubleshooting and minor repairs on lab equipment.
Follow and perform other job-related duties as requested.
GENERAL REQUIREMENTS:
The position requires good attendance, a standard eight-hour day, and five-day work week. The employee must be fluent in written and spoken English. Position may require working overtime and weekends. All employees are required to comply with the organization’s Privacy Policy. Failure to abide by these requirements may result in the employee’s immediate termination.
SUPERVISORY RESPONSIBILITY:
None.
EDUCATION AND/OR EXPERIENCE:
MS in Analytical Chemistry or equivalent degree in physical sciences with a minimum of 5 years or PhD with minimum of two years of relevant laboratory experience, BS with a minimum of 8 years.
QUALIFICATIONS:
To perform this job 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. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
In-depth knowledge of Pharmaceutical operations, including lab procedures and equipment, instrumentation, safety procedures, and laboratory practices; mathematical analysis and statistical computations; government regulations.
Working knowledge of personal computers and legible handwriting.
Interface with internal and external customers and vendors.
Ability to work independently.
PHYSICAL REQUIREMENTS: 1. The employee is required to:
Stand, walk, push, twist, reach overhead, and bend to the floor.
Frequently move items up to 50 pounds and occasionally required to move items or objects up to 100 pounds.
Occasionally required to climb ladders and/or steps to reach equipment.
2. Visual Ability:
Visual accommodation necessary for reading precision measuring equipment, machine dials, gauges, and thermometers; must be able to observe fine details under microscope; must be able to distinguish color indicator changes in test solution.
3. Smelling Ability:
Must have sense of smell to detect odors of unacceptable compounds and/or mixtures.
4. Manual Dexterity:
Must have steady hands and good physical coordination in order to handle delicate laboratory instrumentation and equipment.
5. Hearing Ability:
Must be able to hear alarms, detect machine sounds and malfunctioning equipment to identify and diagnose changes so appropriate action can be taken.
6. Working Conditions: The employee is subject to:
High noise levels from operating machinery
Skin exposure to oils, vapors, and a variety of chemicals. (Required to wear gloves when working with hazardous materials.)
Breathing exposure to dust, mists, and fumes
The employee may be required to wear a respirator and must pass the required respirator evaluation test.
COMPANY POSITION STATEMENT:
This is not necessarily an exhaustive list of all responsibilities, duties, performance standards or requirements, efforts, skills or work conditions associated with this position. While this is intended to be an accurate reflection of the current job, Aptalis reserves the right to revise the job or to require that other or different tasks be performed when circumstances change (e.g. emergencies, change in workload or technology developments).
APTALIS - 13 months ago
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