QC Analyst I, II, or III - 2nd shift

Company: Recro Pharma, Inc ( Learn More )

General Information
US-GA-Gainesville
N/A
Not Specified
Full-Time
Not Specified
Not Specified
False
False
Job Description

The QC Analyst I position is an entry level analyst position. The QC Analyst I is required to complete the most comprehensive in-house training program for all laboratory activities. Documented proficiency is required before the QC Analyst I can perform tasks independently. Because of the level of experience required for this position, the scope of work is generally limited to routine testing explicitly following written test protocols, however, upon the discretion of QC supervisory staff the QC Analyst I may be called upon to execute non-routine testing to support method validation, and method transfer. In addition, the QC Analyst I may be called upon to write or revise SOPs, analytical procedures, and analysis reports, or qualify as trainers on specific procedures.

The QC Analyst II must be proficient at basic analytical techniques such as pipetting, weighing, drying, filtering, etc.; and must have industry experience (preferably in an FDA regulated industry) with one or more techniques in automated instrumental analysis (HPLC, GC, dissolution) or wet chemical analysis (compendial methods). The QC Analyst II requires in-house training for most laboratory activities, but consideration is given to individual training needs based on prior experience; however documented proficiency is required for the execution of all activities. Because of the level of experience, and training associated with this position, a QC Analyst II may be assigned the responsibility of specialized compliance functions within the laboratory, such as controlled substance management, reference standard inventory control, cleaning validation swab procedures, and method validation and transfer activities. The QC Analyst II will be required to write or revise SOPs, analytical procedures, and analysis reports, at the discretion of quality control supervisory staff.

The QC Analyst III position is a highly experienced analyst position within the QC laboratory. The QC Analyst III requires the least comprehensive in-house training curriculum of any analyst position in the laboratory by virtue of prior experience, although documented proficiency is required for the execution of all activities. Because of the level of experience associated with this position, a QC Analyst III may be assigned the responsibility of specialized compliance functions within the laboratory, such as controlled substance management, equipment IQ, OQ, PQ activities, reference standard inventory control, cleaning validation swab procedures, and method validation and transfer activities. The QC Analyst III will be required to write or revise SOPs, analytical procedures, analysis reports, validation documents, etc. at the discretion of quality control supervisory staff.

Job Requirements

QC Analyst I - Bachelor’s Degree in chemistry or related scientific discipline is required and one (1) year of work experience in a pharmaceutical/biologics lab environment with cGMP experience is preferred.

QC Analyst II - Bachelor’s Degree in chemistry or related scientific discipline and a minimum of three (3) years of Quality Control lab experience in the pharmaceutical/biologics industry with cGMP experience is required.

QC Analyst III - Bachelor’s Degree in chemistry or related scientific discipline and a minimum of six (6) years of Quality Control lab experience in the pharmaceutical/biologics industry with cGMP experience is required.

The employee must regularly lift and /or move up to 10 pounds, frequently lift and/or move up to 25 pounds and occasionally lift and/or move up to 50 pounds. While performing the duties of this job, the employee is regularly required to stand; use hands to finger, handle, or feel; reach with hands and arms and talk or hear. The employee is frequently required to sit, climb, balance and write legibly. The employee is occasionally required to walk; stoop, kneel, crouch, or crawl and taste or smell.

Specific vision abilities required by this job include close vision, color vision, and the ability to adjust focus. Must have corrected visual acuity of 20/40 or better bilaterally. The employee must be able to pass color/contrast testing passing 9 of 12 elements.

In certain assignments, the employee will occasionally be exposed to fumes or airborne particles. The employee will frequently be exposed to toxic or caustic chemicals. The employee will be regularly required to wear personal protective equipment such as a lab coat, protective gloves, ear protection and protective safety glasses throughout much of the day. The employee will be required to pass a Pulmonary Function Test (PFT) in order to wear a half-face respirator occasionally for certain assignments.