Quality Control Chemist I

Nature and Scope

Perform QC related work including, but not limited to, preparing/performing analysis samples from all phases of a manufacturing or other handling processes and creating/revising SOPs.

Essential Duties and Responsibilities

Nothing in this job description restricts management's right to assign or reassign duties and responsibilities to this job at any time.

• Perform QC testing in all phases of manufacturing including raw material, in-process, bulk, finished goods and stability testing.
• Conduct various laboratory procedures as per manufacturing/QC SOPs.
• Assist fundamental tasks for special projects on analytics and instruments.
• Prepare and maintain testing records.
• Involve in procedure review and propose modifications and updates.
• Support design and development of experimental protocols, SOP's, etc., consistent with cGMP/GLP.
• Under general supervision, manage own time effectively, maintains control over all current assignments and responsibilities.
• Perform any other tasks/duties as assigned by management.

Education Requirements and Qualifications

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill and/or ability required.

• BS degree in Chemistry, Biology or equivalent combination of education and experience.
• Up to 2 years of related quality control and quality assurance in the pharmaceutical industry.

• Require/Preferred Experience with specific equipment/software/programs etc.

• Clean, organize and legible documentation.
• Knowledge of cGMP environment is a plus.
• Able to follow, create, maintain, and organize documents per established company guidance.
• Knowledge of workplace safety and safe materials handling as appropriate
• Must be able to read documents in Standard English such as Standard Operating Procedures, maintenance schedules and operating manuals.
• Ability to work overtime as needed.

Physical Environment and Requirements

• Physically able to wear laboratory protective gowning and equipment, including but not limited to gowning, goggles, face shields, respirators, and protective gloves. PPE and Respirators are essential for the health and safety of employees.

• Specific vision requirements include 20/20 near vision (can be corrected with eyeglasses or contacts) and color vision.

• Specific vision requirements include color vision.

• Employees must maintain a clean-shaven appearance each working shift to wear tight-fitting respirators properly.
• Employee must be able to occasionally lift and/or move up to 50 pounds.

Expected Salary Range:

$33.70-35.00

American Regent celebrates diversity and we are committed to creating an inclusive environment for all employees. We are an Equal Opportunity Employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability status, or protected veteran status.

Applicants have rights under Federal Employment Laws.

• FMLA poster: https://www.dol.gov/whd/regs/compliance/posters/fmlaen.pdf
• Know Your Rights: Know Your Rights: Workplace discrimination is illegal (eeoc.gov)
• Employee Polygraph Protection Act: https://www.dol.gov/whd/regs/compliance/posters/eppac.pdf

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