Vacancy expired!
FUNCTION STATEMENT:
Responsible for the routine testing of raw material, in-process, stability, and/or finished product samples. Coordinates the timely completion of routine and special request testing and utility testing. Anticipate the materials needed for future scheduled projects. Assists with training of new employees and performing laboratory data review. Keeps Laboratory Supervisor informed of all departmental activities.
POSITION SUMMARY:
Reports to QC Chemistry Supervisor
Duties are of routine nature but are followed according to established standard operating procedures. Problem recognition ability is needed. Non-critical functions utilize independent action and decision making with follow-up reporting to supervision.
Supervisor directly responsible for training, assignment of duties and review/approval of work. Direction, training and some day-to-day supervision may also come from a Scientist or Senior Scientist.
PRINCIPAL ACTIVITIES PERFORMED BY THE INCUMBENT:
Develops new Standard Operating Procedures for laboratory test procedures. Maintains SOPs to assure constant compliance with corporate and regulatory requirements.
Monitors and tracks laboratory test results.
Assists in Training new department personnel in standard operating procedures.
Informs supervisory personnel of all relevant events impacting the operations and performance of the department.
Maintains knowledge of cGMPs and GLPs.
Provides validation test support.
Performs Preventative Maintenance for departmental equipment.
Follows safety requirements and maintains good housekeeping of lab areas.
Supports new product development related testing as directed.
Writes and executes protocols for equipment validations and special projects.
Performs routine analysis related to the testing and release of Raw Material, Stability, In-Process Finished Product and/or Stability.
Prepares and performs routine analysis by HPLC, GC and/or AA including assay and impurity methods, collects, processes and calculates generated data.
Assist with the execution of equipment and method validation protocols.
Checks and reviews data.
Responsible for compiling Annual Quality Product Reports.
Assumes additional duties and responsibilities as assigned.
REQUIREMENTS:
B.S. in Chemistry or related field with 0-3 years experience preferred.
Four Year College Degree with 3 5 years experience.
Associates Degree with 5+ years experience.
Excellent verbal and written communication skills are essential.
Vacancy expired!