QC Scientist III

Nature and Scope

As part of a team of Analytical Chemists, this position is responsible for performing the analytical activities necessary to support finished product and raw material groups.

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.

• Responsible for performing routine testing on raw materials and/or finished product pharmaceuticals in compliance with cGMPs.

• Execute wet chemical and analytical methods to assess the purity, potency and stability of drug substances and finished products.

• Assist in the identification of synthetic impurities and potential degradation products utilizing various chromatographic and spectroscopic techniques.

• Perform analytical analysis using HPLC, GC, UV/VIS and FTIR.

• Create and maintain accurate lab record documentation.

• Perform routine maintenance and calibration of laboratory instrumentation.

• Monitor progress and coordinate completion of routine testing to meet commercial production and release deadlines.

• Mentor and trains junior chemists within the Group.

• Provide technical problem solving and troubleshooting for technicians and analysts.

• Plan and implement projects and studies as assigned by manager.

• Ensure all work is performed and documented in accordance with existing company policies, procedures, Current Good Manufacturing Practices, health, and safety requirements.

• 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.

• B.S. in Chemistry, Pharmaceutical Science or related field required.

• Minimum 6 years pharmaceutical Quality Control laboratory experience.

• Supervisory experience preferred.

• Thorough knowledge of cGMP and USP requirements.

• Expertise in operation and maintenance of laboratory equipment (HPLC, GC, IR, UV-Vis).

• Demonstrated problem solving, planning and organization skills.

• Excellent interpersonal and communication skills (oral and written).

Physical Environment and Requirements

• While performing duties of the job, incumbent is occasionally required to stand; walk; sit; use hands to finger, handle or feel objects, tools or controls; reach with hands and arms; balance; talk and hear.

• 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.

• Employees must maintain a clean-shaven appearance each working shift to wear tight-fitting respirators properly.

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

• Employee must be able to occasionally lift and/or move up to 25 pounds.

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.

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