Description

Perform various analytical tests on mass/finished goods in a compliant and timely fashion while following cGMPs and industry⁃standard safety practices. Responsible for overseeing and performing stability testing on OTC product to assure that it meets established specifications and conforms to all applicable FDA, USP, and Company standard practices and regulations. Daily analysis will include physical and chemical testing using wet chemistry techniques and analytical instrumentation. Responsible for evaluating results of self and others and for informing management of critical issues in a timely manner.⁃ 50 % ⁃⁃ Test and analyze OTC product, non⁃OTC product, and other material as assigned. Use UPLC/HPLC and ICP⁃OES instruments and related software to acquire, process, and document test results. Conform to all applicable cGMP and safety guidelines.⁃ 10 % ⁃⁃ Troubleshoot instrumentation issues and out⁃of⁃specification (OOS) or out⁃of⁃trend results. Use clear reasoning to develop and evaluate investigation hypotheses, results, and any corrective and/or preventative actions needed. Assist in evaluating and troubleshooting third⁃party OOS investigations.⁃ 10 % ⁃⁃ Oversee and provide guidance on daily activities for Chemist I and entry⁃level staff (lab technicians and interns) regarding best practices for test methods, troubleshooting instruments, and interpreting test results. Assist in the assignment of workload and disposition of tested materials.⁃ 10 % ⁃⁃ Document results following laboratory guidelines and cGMP practices. Clearly, concisely, and logically communicate issues and outcomes to management in a timely fashion.⁃ 10 % ⁃⁃ Track and trend stability results.⁃ 5 % ⁃⁃ Assist in training of Chemist I and entry⁃level staff.⁃ 5 % ⁃⁃ Perform other tasks as assigned, ensuring smooth laboratory workflow and daily operations.

Qualifications

⁃ Must have working knowledge of analytical techniques (conventional and instrumental, including chromatography and emission spectrometry) and all instrumentation typically found in a well⁃equipped pharmaceutical analysis lab.⁃ Must have working knowledge of Microsoft Office (Word and Excel, Access a plus). Waters Empower experience a plus.⁃ Must have knowledge of OTC and FDA guidelines and applied knowledge of GMPs.⁃ Must have demonstrated problem solving skills with ability to conduct root cause analysis in laboratory investigations.⁃ Must have excellent oral & written communication skills and strong organizational skills.⁃ Must be able to work additional time as needed.⁃ Experience in high throughput lab a plus.⁃ Cosmetic and pharmaceutical experience a plus.⁃ SAP skills and experience a plus.⁃ Minimum 3⁃4 years experience⁃ Bachelor's Degree in Chemistry or Biochemistry

Equal Opportunity Employer

It is Company's policy not to discriminate against any employee or applicant for employment on the basis of race, color, creed, religion, national origin, ancestry, citizenship status, age, sex or gender (including pregnancy, childbirth and related medical conditions), gender identity or gender expression (including transgender status), sexual orientation, marital status, military service and veteran status, physical or mental disability, protected medical condition as defined by applicable state or local law, genetic information, or any other characteristic protected by applicable federal, state, or local laws and ordinances. The Company will endeavor to provide a reasonable accommodation consistent with the law to otherwise qualified employees and prospective employees with a disability and to employees and prospective employees with needs related to their religious observance or practices. Should you wish to apply for this position or any other position with the Company and you believe you require assistance to complete an application or participate in an interview, please contact USApplicantAccommodations@Estee.com.