Job Title: QC Laboratory
Effective Date /
Last Modification Date: 20OCT15
Conduct laboratory work as necessary to assure that products are tested per operating procedures. Ensure that work is carried out in an efficient and safe manner. Utilizes judgment in making adaptation and modifications on all assignments.
Assures appropriate review of analytical results commensurate with Patheon review policy
Maintains equipment calibration schedule and ensure that all required calibrations and maintenance are completed in a timely fashion
Follow standard operating procedures and assist with revision process of current procedures.
Ensures laboratory compliance with applicable regulations
Assists with on the job procedural, cGMP, and safety training of new laboratory staff
Acts as communication liaison for laboratory with other facility departments.
Ensures timely and accurate method transfers from method development group.
Performs analytical testing of raw materials, in-process samples, and finished products using analytical laboratory instrumentation, such as HPLC, GC, CE, ICP, and dissolution apparatus as necessary.
Assists with preparations for internal and external laboratory audits and inspections.
Receives assignments in the form of objectives and determines how to use resources to meet schedules and goals.
Coordination of the daily activities of a section and/or department with responsibility for results.
Bachelor's degree in Chemistry preferred.
Experience Preferred (minimum - BS biology/chemistry graduate)
1-2 years of experience working in a laboratory, (GLP or GMP/cGMP environment preferred) 1-2 years of experience working with analytical instrumentation, such as HPLC, GC, CE, ICP and dissolution apparatus
Equivalent combinations of education, training, and relevant work experience may be considered.
Ability to drive functional, technical and operational excellence. Ability to inspire and drive team effectiveness. Good knowledge of medical terminology, clinical data, and Good Manufacturing Practices (GMP). Strong proficiency in Microsoft Office Suite (Word, Excel, and PowerPoint. Effective written, interpersonal, and presentation skills. Ability to work on multiple projects simultaneously.
Position requires ordinary ambulatory skills and physical coordination sufficient to move about office locations; ability to stand, walk, stoop, kneel, crouch periodically for prolonged periods of time; manipulation (lift, carry, move) of light to medium weights of 10-35 pound pounds; arm, hand and finger dexterity, including ability to grasp and type for prolonged periods of time; visual acuity to use a keyboard, computer monitor, operate equipment, and read materials for prolonged periods of time; ability to sit, reach with hands and arms, talk, and hear for prolonged periods of time.
This job description is intended to present the general content and requirements for the performance of this job. The description is not to be construed as an exhaustive statement of duties, responsibilities, or requirements. Managers and supervisors may assign other duties as needed. Nothing contained herein should be construed to create an employment contract. Occasionally, required skills/experiences for jobs are expressed in brief terms. Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees.
FOR HR USE ONLY
Job Code(s): Florence, SC / Job Code:
Job Category: Categories to be determined by Corporate HR
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