Share Email Opening Title QC Analyst I, II, or III - 1st/2nd Shift  Category Quality Control   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. All three roles perform testing and inspection of any and all samples submitted to the laboratory in a cGMP compliant manner following written procedures and good documentation practices. In addition, they perform data management activities, maintain workspaces in inspection ready state, perform housekeeping and glassware maintenance, review and document test results, track and dispose of waste, maintain supplies, and comply with all regulations, policies and procedures applicable to the site (DEA, FDA, OSHA, etc.)   Position 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.   About the Organization Societal is a bi-coastal contract development and manufacturing organization (CDMO) with expertise to deliver on our client's needs, regardless of complexity level. These projects span pre-Investigational New Drug (IND) development to commercial manufacturing and packaging for a wide range of therapeutic dosage forms. We provide industry leading support for small molecule therapeutic development, end-to-end regulatory support, clinical and commercial manufacturing, aseptic fill/finish, lyophilization, packaging and logistics services to the global pharmaceutical market. We do all of this in our best-in-class facilities in San Diego, California and Gainesville, Georgia. New hires will pass a background check and drug screen as a condition of employment.   EOE Statement We are an EOE dedicated to a diverse workforce and a Drug-Free work environment. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, status as a protected veteran, or any other characteristic protected by law. If you require an accommodation to complete the application or interview process, please contact careers@societalcdmo.com.   EmpID None Specified  This position is currently not accepting applications. To search for an open position, please go to http://Societal.appone.com WE ALSO RECOMMEND Other Jobs Within Same Category -- None found -- Other Jobs Within 60 Miles -- None found --

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