SCIENTIFIC PROTEIN LABORATORIES LLC
POSITION TITLE:
QC Analyst - HPLC
PRIMARY OBJECTIVE OF POSITION
Responsible for performing HPLC analyses on APIs (Active Pharmaceutical Ingredients)
following strict written procedures derived from the United States Pharmacopoeia (USP) and/or
other documents, to meet strict compendial and custom specifications. This work is performed
under the cGMP/FDA (Current Good Manufacturing Practice/Food and Drug Administration)
guidelines.
DUTIES AND RESPONSIBILITIES
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Participate in and follow departmental training, SOP, procedure and protocol
documentation as required. Train other analysts on HPLC assay as required.
In a timely manner, prepare reagents, verify the documentation of those reagents and
maintain inventory levels of quality stock reagents and standards.
Responsible for preparation of the purchase of reagents and lab supplies. Accurately
forecast supplies,
equipment and maintenance needs.
Follow Standard Operating Procedures (SOPs) to obtain accurate results. Write/revise
SOPs to ensure compliance with compendial documents.
Perform chemical, microbiological, and PCR testing and interpret the results of raw
material, in-process and finished product APIs and special products.
Author and/or execute chemical experiments, analytical method and instrument validation
efforts as necessary.
Properly record all data results on appropriate documents and in electronic files. Review
and interpret the work of other analysts.
Oversee and/or perform analytical investigations for OOS (Out-of-Specification) and OOT
(Out-of-Trend) chemical data.
Ensure that the work area is maintained in clean condition and free from clutter. Assist in
reporting obstacles that hinder the cleanliness of the laboratory.
Perform routine calibration and preventive maintenance of laboratory equipment.
May be required to cross- train in other areas of the laboratory as necessary.
Schedule and perform HPLC work as required to meet company objectives.
Some amount of self training and independent action is necessary in this position.
Customer focus and participation in project meetings needed.
Perform other duties as assigned.
JOB STANDARDS
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Education: Minimum of a Bachelor’s Degree in Chemistry, Biochemistry or related
scientific discipline is required. Degree requirements may be substituted by year-for-year
work experience in a directly related position. A working knowledge of chemical
laboratory techniques and theories is required.
B.
Experience: Minimum three (3) years of previous industrial chemical laboratory
experience are required. Four (4) years of previous industrial chemical laboratory
experience are preferred. Must have working knowledge of IC HPLC methodology. Must
have hands on experience with Dionex and Waters or Agilent HPLC systems.
C.
Job Standards: Ability to follow company and departmental policies. Ability to provide
input requiring guidelines, to ensure proper operation of laboratory. Highly motivated
individual who can demonstrate initiative, and provide suggestions for improvement.
Ability to work accurately with a sense of urgency, and must be organized. Must be a
team-oriented individual, able to communicate effectively and to work cooperatively with
others, across departments. Must be able to identify, report and assist in the correction of
unsafe working conditions immediately. Good communication skills, both written and oral
are required. Good attendance is required. Good computer skills including experience
with word processing, spreadsheets, and E-mail required. Demonstrated computer
experience in WORD and EXCEL is required. Must be able to perform routine and
complex mathematical calculations involving concentrations, dilutions, etc. Previous
cGMP chemical laboratory experience is required. Data entry of results in computer
spreadsheets is required daily. Experience with routine and some complex laboratory
instrumentation (such as Fume Hoods, pH Meters, Analytical Balances, Conductivity
Meters, Titrators, FTIR, HPLC and/or GC) is required.
D.
Work Environment: Typical Laboratory environment. PPE (Personal Protective
Equipment) Required. This will include safety glasses, laboratory coats. This may include
gloves, dust masks and/or respirators. Overtime, weekend, first and/or second shift
coverage may be required.
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Physical Standard: The job requires standing, sitting, walking, bending, twisting,
squatting and reaching. Frequent lifting of 1-20 lbs. and occasional lifting of 21-60 lbs. is
required.
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