Executes testing of all active substances, raw materials (excipients) and finished dosage forms according to defined procedures under close direction
Participates in the self-directed work team in prioritizing, scheduling and resource allocation in order to maintain efficient workflow to assure completion of schedules, fully synchronized with the Process Oriented Unit
Support deviation investigations including OOS/OOE/OOT
Participates in laboratory operational improvement projects
Ensure that all activities are performed according to the local Quality System and SOP’s, as well as national and local regulations
Demonstrate behaviors and positive attitudes in line with Quality Assurance values.
Performs other duties as may be required or necessary
Follow all hazardous materials and hazardous waste management regulations and guidelines.
Ensure compliance with GMP/HSE regulations.
Champion a Quality Culture and ensure a safe working environment.
As appropriate, responsible for implementation of, compliance to, and governance of practices and principles specifically prescribed to this role by the Operational Standards for Supply Chain Excellence .
Demonstrates and role models the values and behaviors
Employees may be required to inspect products or packaging, or any other task where near visual and/or color acuity is necessary. Possess visual acuity no worse than 20/20 uncorrected or correctable to 20/20 with combined eyes.· Employees must be able to lift or handle objects greater than 25 pounds to perform certain duties essential to the job unction.
Employees may be required to perform tasks essential to the job function in areas that require the use of hearing protection devices.
Performance of tasks essential to the job function may require the employee to work directly with, handle, or otherwise come into contact with chemicals or pharmaceutical agents (including potent compounds).
Employees must be able to gain access to elevated work surfaces via vertical ladders or stairs to perform tasks essential to the job function.
Employees may be required to enroll in a medical surveillance program based on the potential exposure to certain health hazards encountered as a result of their job function
1 year or more of work experience in pharmaceutical and commercial environment is preferred.
Previous hands-on practical laboratory experience is required.
Must have a demonstrated working knowledge of scientific principles.
Must be able to demonstrate basic decision-making skills.
Must possess good oral and written communication skills.
Must be able to demonstrate sound judgment.
Must have demonstrated problem solving abilities.
Strong organizational skills are required.
Good computer skills are required. Working knowledge of MS word, Excel, Power point is a plus.
Experience working in an FDA regulated environment is highly desired.
Must be willing to work as part of a team and demonstrate good interpersonal skills.
Source: Job Diva – Job Listing